Nortriptyline
Tricyclic antidepressant. Nortriptyline is a metabolite of amitriptyline.
CATEGORY: "Safe use of nortriptyline during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards"[G6].
BREAST FEEDING: The American Academy of Pediatrics has classified nortriptyline as a drug "for which the effect on nursing infants is unknown but may be of concern" [G3].
The WHO Working Group on Human Lactation estimated that 2% of the maternal daily dose would be ingested by a breast feeding infant, and concluded that breastfeeding while taking this medication is probably safe.[G8].
NEONATAL SIDE EFFECTS: Possible urinary retention [1].
CERCA LETTERATURA
1.Shearer WT et al.: Urinary retention in a neonate secondary to maternal ingestion of nortriptyline. J Pediatr 81:570-2, 1972.
MEDLINE
NSAID
CATEGORY:B or C in early pregnancy depending on compound.
CATEGORY:D near term .
NSAIDs used near term may cause premature closure of the ductus arteriosus, and inhibit labor. Oligohydramnios after prolonged use is a common complication with NSAIDs as a class.
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Nystatin, vaginal tablet
Antifungal
CATEGORY: C
BREAST FEEDING: Compatible.[G1].
NEONATAL SIDE EFFECTS: None reported.
CERCA LETTERATURA
Ofloxacin
Anti-infective;Quinolone
CATEGORY:C
BREAST FEEDING:
The American Academy of Pediatrics has classified ofloxacin as a drug "Usually
Compatible With Breastfeeding"
[G3]. However,
Briggs GG et al. do not consider this drug compatible with breast feeding,
because of high excretion of this drug into human milk [G1].
NEONATAL SIDE EFFECTS: None reported.
CERCA LETTERATURA
Olanzapine
Antipsychotic. Monoaminergic antagonist
23 olanzapine-exposed pregnancies resulted in no increase in major or minor anomalies. However, the
sample size is too small to draw firm conclusions [1].
CATEGORY:C
BREAST FEEDING:
The manufacturer does not consider this drug to be compatible with breast
feeding.
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
1.Goldstein DJ, Corbin LA, Fung MC. Olanzapine-exposed pregnancies and lactation: early experience. J Clin Psychopharmacol. 2000 Aug;20(4):399-403.
MEDLINE
Olsalazine
Anti-inflammatory agent for gastrointestinal use. Olsalazine is converted to mesalamine (5-aminosalicylic acid) in the colon.
CATEGORY:C
BREAST FEEDING: The American Academy of Pediatrics has classified 5-aminosalicylic acid as a drug that "should be given to nursing mothers with caution" [G3].
NEONATAL SIDE EFFECTS: May cause diarrhea.
CERCA LETTERATURA
Omeprazole
Proton Pump Inhibitor. Used for control of stomach acid
CATEGORY:C
Although there are a number of case reports of fetal anomalies (anencephaly, hydranencephaly, and talipes) following the use of omeprazole [G1] large human studies have not supported an association between omeprazole and congenital defects[1-4].
BREAST FEEDING: A single case report suggests that there is minimal excretion of omeprazole into human breast milk [5].
Because of the limited data regarding the potential for serious adverse reactions in nursing infants from omeprazole, and because of the potential for tumorigenicity shown for omeprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
1. Lalkin A, Loebstein R, Addis A, Ramezani-Namin F, Mastroiacovo P, Mazzone T, Vial T, Bonati M, Koren G. The safety of omeprazole during pregnancy: A multicenter prospective controlled study. Am J Obstet Gynecol 1998;179:727-30.
MEDLINE
2. Kallen B: Delivery outcome after the use of acid-suppressing drugs in early pregnancy with special reference to omeprazole. Br J Obstet Gynaecol 105:877-881, 1998.
MEDLINE
3.Ruigomez A, Garcia Rodriguez LA, Cattaruzzi C, Troncon MG, Agostinis L, Wallander MA, Johansson S.
Use of cimetidine, omeprazole, and ranitidine in pregnant women and pregnancy outcomes. Am J Epidemiol 150:476-481, 1999.
MEDLINE
4.Kallen BA. Use of omeprazole during pregnancy--no hazard demonstrated in 955 infants exposed during pregnancy.
Eur J Obstet Gynecol Reprod Biol. 2001 May;96(1):63-8.
MEDLINE
5. Marshall JK, Thompson AB, Armstrong D. Omeprazole for refractory gastroesophageal reflux disease during pregnancy and lactation.Can J Gastroenterol. 1998 Apr;12(3):225-7.
MEDLINE
Ondansetron
Ondansetron (Zofran® tablets and injection)
Antiemetic. Selective 5-HT 3 receptor antagonist .
Molecular weight: 365.9. Plasma protein binding of ondansetron as
measured in vitro was 70% to 76%, with binding constant over the pharmacologic
concentration range (10 to 500 ng/mL).
CATEGORY:B
Reproduction studies have been performed in pregnant rats and rabbits at daily
oral
doses up to 15 and 30 mg/kg per day respectively, and have revealed no evidence of impaired fertility
or harm to the fetus due to ondansetron [1].
Reports on the use of ondansetron during the first trimester in human
pregnancy are scarce.
In one case report ondansetron 8 mg IV TID was used to successfully treat hyperemesis gravidarum
in a woman
from approximately 11 to 13 weeks gestation. She gave birth to a term healthy infant [2]. Tincello
and Johnstone also used ondansetron intermittently every trimester to treat
hyperemesis gravidarum in one patient with no apparent adverse effects
on the mother or infant [3].
In a randomized controlled trial comparing ondansetron with promethazine
for the treatment of hyperemesis gravidarum 15 patients were treated with
ondansetron at a mean gestational age of 11 weeks'. Patients were given an
initial dose of ondansetron 10 mg IV with additional doses as need TID.
Ondansetron demonstrated no benefit over promethazine in patients
hospitalized for hyperemesis gravidarum. The authors of
the study suggested that increasing ondansetron dosages or using a
continuous infusion might have improved the treatment response. Pregnancy
outcomes were not reported for either group [4].
In two additional case reports of pregnant women treated with ondansetron
during the third trimester both mothers delivered normal infants [5, 6].
While the above reports are reassuring the number of reported cases is
too
small to draw firm conclusions
regarding the teratogenic risk of
ondansetron in human pregnancy.
BREAST FEEDING: It is not known whether ondansetron is excreted into human milk.
SEARCH LITERATURE
1. Physicians Desk Reference 57th ed.
Montvale, NJ: Thomson PDR;
2004: 1680-2
2. Guikontes E, et al. Ondansetron and hyperemesis gravidarum.Lancet. 1992; 340:
1223.
MEDLINE
3. Tincello DG and Johnstone MJ.Treatment of hyperemesis gravidarum with the 5-HT3 antagonist ondansetron
(Zofran).Postgrad Med J. 1996;72:688-9.
MEDLINE
4. Sullivan CA, et al. A pilot study of intravenous ondansetron for hyperemesis
gravidarum.
Am J Obstet Gynecol. 1996 ; 174: 1565-8.MEDLINE
5. World MJ: Ondansetron and hyperemesis gravidarum.Lancet. 1993; 341:
185.
MEDLINE
6. Arango HA, et al. Management of chemotherapy in a pregnancy
complicated by a large neuroblastoma.Obstet Gynecol. 1994 ;84:665-8.
MEDLINE
Oxacillin
Antibiotic, Penicillin
CATEGORY:B
First trimester exposure to penicillin derivatives in more than 3500 human pregnancies was not associated with an increased risk of
congenital anomalies [G1].
The findings of a more recent small study did not find an increased risk of congenital anomaly after exposure to oxacillin during pregnancy [1].
BREAST FEEDING: Excreted into human breast milk.
NEONATAL SIDE EFFECTS: Possible diarrhea.
CERCA LETTERATURA
1.Czeizel AE, Rockenbauer M, Sorensen HT, Olsen J.Teratogenic evaluation of oxacillin. Scand J Infect Dis. 1999;31(3):311-2.
MEDLINE
Oxaprozin
Nonsteroidal Anti-Inflammatory
CATEGORY:C
NSAIDs used near term may cause premature closure of the ductus arteriosus, and inhibit labor. Oligohydramnios after prolonged use is a common complication with NSAIDs as a class.
BREAST FEEDING:
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Oxazepam
Anxiolytic. Metabolite of diazepam, prazepam and temazepam
CATEGORY:D
BREAST FEEDING: The WHO Working Group on Drugs and Human Lactation considers
oxazepam compatible with breast feeding when taken by mothers in occasional small doses .[G8].
NEONATAL SIDE EFFECTS: Possible sedation and depression.
CERCA LETTERATURA
ADDITIONAL READING: Benzodiazepines in Pregnancy
1999 Illinois Teratogen Information Service
Oxycodone
Opioid analgesic. Molecular weight: 351.83
CATEGORY:B
"Reproduction studies have been performed in rats and rabbits by oral
administration at doses up to 8 mg/kg and 125 mg/kg, respectively. These doses
are 3 and 46 times a human dose of 160 mg/day, based on mg/kg basis. The results
did not reveal evidence of harm to the fetus due to oxycodone." [1]
Results of The Collaborative Perinatal Project
found no increase in the incidence of major malformations among 8
pregnancies exposed during the first trimester to oxycodone [2].
Schick et. al. also found no significant increase
in the incidence of major malformations in 78 pregnancies after
first trimester exposure to oxycodone [3].
Briggs et. al. reported that data from a
surveillance study of Michigan Medicaid recipients did
not support an association between oxycodone
and major malformations in 281
newborns who had been exposed to oxycodone
during the first trimester [4].
BREAST FEEDING: Oxycodone is excreted into breast milk [5, 6]. Withdrawal
symptoms can occur in breast-feeding infants when maternal administration of an
opioid analgesic is stopped. Ordinarily, nursing should not be undertaken while
a patient is receiving oxycodone [1].
NEONATAL SIDE EFFECTS: Drowsiness and withdrawal symptoms in the neonate [7].
SEARCH
LITERATURE
1. Physicians
Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2004: 2856-57
2 Heinonen OP, Slone D, Shapiro S: Birth Defects and Drugs in Pregnancy.
Publishing Sciences Group Inc., Littleton, MA, 1977.p 287
3. Schick B, et al. Preliminary analysis of first trimester exposure to
oxycodone and hydrocodone.[Abstract] Reprod Toxicol. 1996;10:162.
4. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore,
MD: Williams
& Wilkins,2002 p 1053-1054
5. Marx CM, et al. Oxycodone excretion in human milk in the puerperium. [Abstract]
Drug Intell Clin Pharm 1986;20:474.
6. Dickson PH, et al.The routine analysis of breast milk for drugs of abuse in a
clinical toxicology laboratory.J Forensic Sci. 1994 Jan;39(1):207-14. PMID: MEDLINE
7.Rao R and Desai NS OxyContin and neonatal abstinence syndrome. J Perinatol.
2002 Jun;22(4):324-5. PMID: MEDLINE
Paromomycin
Antibiotic, Aminoglycoside.Used in the treatment of intestinal parasites.
CATEGORY:C
In the absence of intestinal ulceration paromomycin is poorly absorbed [1].
BREAST FEEDING: Compatible with breast feeding. Because this drug is poorly absorbed orally high concentrations in breast milk would not be expected [G1].
NEONATAL SIDE EFFECTS: None reported.
CERCA LETTERATURA
1. Gardner TB, Hill DR.Treatment of giardiasis. Clin Microbiol Rev. 2001 Jan;14(1):114-28. Review.
MEDLINE
Paroxetine
Antidepressant
CATEGORY:C
Limited human data suggests no increased
rate of anomaly. However, there is insufficient data on possible behavioral
teratogenic effects .
BREAST FEEDING: Excreted into breast milk. Compatible [1]. The American Academy of Pediatrics has classified paroxetine as a drug "for which the effect on nursing infants is unknown but may be of concern" [G3].
NEONATAL SIDE EFFECTS: Neonatal withdrawal syndrome has been reported after
third trimester in utero exposure [2] .
CERCA LETTERATURA
1. Begg EJ, Duffull SB, Saunders DA, Buttimore RC, Ilett KF, Hackett LP, Yapp P, Wilson DA. Paroxetine in human milk. Br J Clin Pharmacol. 1999 Aug;48(2):142-7.
MEDLINE
2. Nordeng H, Lindemann R, Perminov KV, Reikvam A. Neonatal withdrawal syndrome after in utero exposure to selective serotonin reuptake inhibitors.
Acta Paediatr. 2001 Mar;90(3):288-91.
MEDLINE
ADDITIONAL READING: Paxil (PDF file)
2000 Organization of Teratology Information Services
Penicillamine
CATEGORY:D
BREAST FEEDING: Contraindicated [1,2]
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
1. Ostensen M. Treatment with immunosuppressive and disease modifying drugs during
pregnancy and lactation.
Am J Reprod Immunol. 1992 ;28:148-52.MEDLINE
2. Copper disposition of the fetus and placenta in a patient with untreated
Wilson's disease. Am J Obstet Gynecol. 1993;169:196-8.MEDLINE
Penicillin
CATEGORY:B
BREAST FEEDING: Compatible [1]
NEONATAL SIDE EFFECTS: Rash, diarrhea
CERCA LETTERATURA
1. Matsuda S. Transfer of antibiotics into maternal milk.
Biol Res Pregnancy Perinatol. 1984;5(2):57-60.MEDLINE
Pentazocine
CATEGORY: C,
D*
BREAST FEEDING: It is not known whether this drug is excreted in human
milk.
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
*All narcotics may produce withdrawal
syndrome in neonates with prolonged use.
Permethrin
Scabicide, topical
CATEGORY:B
BREAST FEEDING: Compatible [1]
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
1. Clinical Effectiveness Group (Association of Genitourinary Medicine and
the Medical Society for the Study of Venereal Disease). National guidelines for
the management of scabies. Sex Transm Inf 1999;75:S76-7 (PDF file)
Phenobarbital
CATEGORY:D
BREAST FEEDING:The American Academy of Pediatrics has classified
phenobarbital as a drug that has been associated with
significant effects on some nursing infants and should be given to nursing
mother with caution.[G3].
NEONATAL SIDE EFFECTS: Sedation, rash, withdrawal, methemoglobinemia [G3]
CERCA LETTERATURA
Phenothiazines
CATEGORY:C
BREAST FEEDING: See individual agents.
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Phentermine
Sympathomimetic amine chemically related to amphetamine. Used as appetite suppressant.
CATEGORY:C. Safe use in human pregnancy has not been established. However, a
small controlled prospective cohort study of 98 pregnancies found no increased
risk of spontaneous pregnancy loss, or of major or minor anomalies after first
trimester exposure to the combination phentermine/fenfluramine [1].
BREAST FEEDING: It is not known whether phentermine is excreted into human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
1. Jones KL, Johnson KA, Dick LM, Felix RJ, Kao KK, Chambers
CD.Pregnancy outcomes after first trimester exposure to phentermine/fenfluramine.
Teratology. 2002;65:125-30.
MEDLINEADDITIONAL READING:
Phentermine(PDF file)
2000 Organization of Teratology Information Services
Phenylpropanolamine
The FDA has requested that all drug companies discontinue marketing products
containing phenylpropanolamine, because of an association
between phenylpropanolamine and an increased risk of hemorrhagic stroke in
women.
First trimester exposure has been associated with a statistically significant
increased rate of eye and ear malformations
[G10].
BREAST FEEDING:
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
ADDITIONAL READING: Over the Counter Cold Medications in Pregnancy
1998 Illinois Teratogen Information Service
Phenytoin
Anticonvulsant
CATEGORY:D
Fetal Hydantoin Syndrome: Cardiac defects, dysmorphic craniofacial features, hypoplastic nails, and distal phalanges, intrauterine growth restriction, and microcephaly. Mental retardation may be seen when the full syndrome is present.
Up to 30% of exposed fetuses may have anomalies; The full syndrome occurs in 10% of exposed fetuses [1].
Fetuses with low activity of the enzyme microsomal epoxide hydrolase appear to be at highest risk for developing the syndrome. [2].
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Rare methemoglobinuria
CERCA LETTERATURA
1.Teratology. ACOG technical bulletin number 236--April 1997
2. Buehler BA et al.,Prenatal prediction of risk of the fetal hydantoin syndrome. N Engl J Med 322:1567, 1990 MEDLINE
Pindolol
Hypotensive agent, beta-adrenergic blocking agent
CATEGORY:B
BREAST FEEDING: The manufacturer does not consider pindolol to be compatible
with breast feeding.
NEONATAL SIDE EFFECTS: Possible hypotension, bradycardia
CERCA LETTERATURA
Piroxicam
Nonsteroidal Anti-Inflammatory
CATEGORY:C
NSAIDs used near term may cause premature closure of the ductus arteriosus, and inhibit labor. Oligohydramnios after prolonged use is a complication with NSAIDs as a class.
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Potassium
CATEGORY: C
BREAST FEEDING: Compatible [G1].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Potassium
Iodide
Expectorant
CATEGORY:D
Crosses placenta. Prolonged use may cause hypothyroidism in the fetus.
BREAST FEEDING: Compatible
[G9].
NEONATAL SIDE EFFECTS: Goiter, allergic
reactions
CERCA LETTERATURA
Pravastatin
Antilipemic Agent, HMG-CoA reductase inhibitor
CATEGORY:X
BREAST FEEDING: Contraindicated
[G1].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Prednisone
Corticosteroid
CATEGORY:" The use of these drugs (corticosteroids) in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus."[G6].
Many older studies including a surveillance study of Michigan Medicaid recipients do not support an association between prenatal prednisone exposure and congenital anomalies[G1].
However, more recent studies suggest a possible increased risk of oral cleft when prednisone is used during the first trimester in humans [1,2].
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
CERCA LETTERATURA
1. Carmichael SL; Shaw GM: Maternal corticosteroid use and risk of selected congenital anomalies. Am J Med Genet 1999;86:242-4.
MEDLINE
2.Park-Wyllie L, Mazzotta P, Pastuszak A, Moretti ME, Beique L, Hunnisett L, Friesen MH, Jacobson S, Kasapinovic S, Chang D, Diav-Citrin O, Chitayat D, Nulman I, Einarson TR, Koren G. Birth defects after maternal exposure to corticosteroids: prospective cohort study and meta-analysis of epidemiological studies.
Teratology. 2000 Dec;62(6):385-92.
MEDLINE
ADDITIONAL READING: Corticosteroids in Pregnancy
2000 Illinois Teratogen Information Service
Premarin (Conjugated estrogen)
CATEGORY:X
BREAST FEEDING:
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Primidone
Anticonvulsant
CATEGORY:D
BREAST FEEDING: The American Academy of Pediatrics has classified primidone as a drug that has been associated with significant effects on
some nursing infants and should be given to nursing mother with caution.[G9].
NEONATAL SIDE EFFECTS: Sedation.
CERCA LETTERATURA
Procainamide
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G9].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Prochlorperazine
CATEGORY:C
BREAST FEEDING:
NEONATAL SIDE EFFECTS: Possible sedation.
CERCA LETTERATURA
Progesterone
CATEGORY:B
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Promethazine
CATEGORY:C
BREAST FEEDING: With caution
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Propanolol
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:Hypotension,bradycardia
CERCA LETTERATURA
Propoxyphene
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Withdrawal
CERCA LETTERATURA
Propylthiouracil
CATEGORY:D
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Potential for
hypothyroidism
CERCA LETTERATURA
Pseudoephedrine
Sympathomimetic agent used as a decongestant (vasoconstrictor). Molecular weight:201.70
CATEGORY:
C
A retrospective study by Werler MM, et al.
, found that among mothers of 206 infants with gastroschisis and 126 mothers of
infants with small intestinal atresia infants with gastroschisis had an
increased risk (odds ratio = 1.8) of having been exposed to pseudoephedrine
during gestation. The risk for gastroschisis was increased further (odds ratio =
4.2) among infants who had been exposed to pseudoephedrine combined with
acetaminophen. The risk of small intestinal atresia was also increased for any
use of pseudoephedrine (odds ratio = 2.0) and for use of pseudoephedrine in
combination with acetaminophen (odds ratio = 3.0). The authors of the study
cautioned that underlying maternal illness may have confounded the results of
this study [1].
Gastroschisis is a congenital defect of the anterior abdominal wall
characterized by an opening beside the umbilical cord that allows bowel to
protrude. Gastroschisis is thought to arise from disruption of blood flow
to the affected abdominal wall [2]. The defect is uncommon and occurs in the
general population with an incidence of 2.4 to 3.2 per 10,000 births in
the general population with the highest incidence in women 15-19 years of age (
26.5 per 10,000 births) [3,4]. The uncommon occurrence of gastroschisis should
be considered when counseling patients or interpreting the literature as to the
increased risk for gastroschisis after any particular drug ingestion.
In contrast to the above epidemiological study by Werler MM, et al. three
retrospective studies of 1,842 newborns exposed to pseudoephedrine during the
first trimester found no increased risk for malformations [5-7]. In addition a
prospective study by Schatz et al. also found no increased risk for
malformations in 714 infants after exposure to pseudoephedrine at any time
during pregnancy[8].
The American College of Obstetricians and Gynecologists (ACOG) and The
American College of Allergy, Asthma and Immunology (ACAAI) recommend oral
decongestants be avoided during the first trimester "...unless the expected
benefit is large and unique" [9].
BREAST FEEDING: Pseudoephedrine is excreted into breast milk and may suppress
lactation [10, 11]. The reported milk:plasma ratio (at 3 hours) is 3.9 [10]. At
the maximum recommended pseudoephedrine doses, the calculated infant dose
delivered via milk is less than 10% of the maternal dose [11]. The American
Academy of Pediatrics and the WHO Working Group on Human Lactation consider the
occasional use of pseudoephedrine to be compatible with breast feeding [12, 13].
NEONATAL SIDE EFFECTS: Agitation
SEARCH
LITERATURE
ADDITIONAL READING: Over
the Counter Cold Medications in Pregnancy
1998 Illinois Teratogen Information Service
1.Werler MM, et al Maternal medication use and
risks of gastroschisis and small intestinal atresia. Am J Epidemiol.
2002;155:26-31 MEDLINE
2. Hoyme HE, et al. ;The vascular pathogenesis of gastroschisis: intrauterine
interruption of the omphalomesenteric artery.J Pediatr. 1981;98:228-31.MEDLINE
3. Reid KP, et al., The epidemiologic incidence of congenital gastroschisis in
Western Australia. Am J Obstet Gynecol. 2003;189:764-8. MEDLINE
4. Nichols CR, et al., Rising incidence of gastroschisis in teenage pregnancies.
J Matern Fetal Med. 1997;6:225-9.MEDLINE
5. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,
Baltimore, MD: Williams
& Wilkins,2002 p 1187.
6. Aselton P et al. First-trimester drug use and congenital disorders. Obstet
Gynecol. 1985;65:451-5. MEDLINE
7. Jick H et al. First-trimester drug use and congenital disorders.JAMA.
1981;246:343-6. MEDLINE
8. Schatz M et al. The safety of asthma and allergy medications during pregnancy.
J Allergy Clin Immunol. 1997;100:301-6.MEDLINE
9. The use of newer asthma and allergy
medications during pregnancy. Position Statement. The American College of
Obstetricians and Gynecologists (ACOG) and The American College of Allergy,
Asthma and Immunology (ACAAI). Ann Allergy Asthma Immunol. 2000;84:475-480. MEDLINE
10. Findlay JW et al: Pseudoephedrine and
triprolidine in plasma and breast milk of nursing mothers. Br J Clin Pharmacol
18:901-6, 1984. MEDLINE
11. Aljazaf K, Pseudoephedrine: effects on milk production in women and
estimation of infant exposure via breastmilk.Br J Clin Pharmacol. 2003;56:18-24.
PMID: MEDLINE
12. The
WvHO Working Group, Bennet PN (ed).: Drugs and Human Lactation. Elsevier,
Amsterdam, New York, Oxford, 1988.
13.Transfer
of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89.
Review.
Pyrantel
pamoate
CATEGORY:C
BREAST FEEDING:
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Pyridostigmine
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Pyridoxine
CATEGORY: A
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Pyrimethamine
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Vomiting, marrow
suppression
CERCA LETTERATURA
Quinapril
Antihypertensive; ACE inhibitor
CATEGORY: C first trimester
CATEGORY: D second and third trimesters
2nd and 3rd trimester ACE inhibitor exposure is associated with hypocalvaria, and renal defects related to fetal hypotension and decreased
renal perfusion. The latter may result in oligohydramnios.
BREAST FEEDING: Excreted into human milk. Compatible [1].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
1.Begg EJ, Robson RA, Gardiner SJ, Hudson LJ, Reece PA, Olson SC, Posvar EL, Sedman AJ. Quinapril and its metabolite quinaprilat in human milk.
Br J Clin Pharmacol. 2001 May;51(5):478-81. MEDLINE
Quinidine
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:Anemia,rash,arrhythmias,optic
neuritis
CERCA LETTERATURA
Raloxifene
Selective estrogen receptor modulator (SERM)
CATEGORY:X
BREAST FEEDING: Contraindicated
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Ramipril
Antihypertensive; ACE inhibitor
CATEGORY: C first trimester
CATEGORY: D second and third trimesters
2nd and 3rd trimester ACE inhibitor exposure is associated with hypocalvaria, and renal defects related to fetal hypotension and decreased
renal perfusion. The latter may result in oligohydramnios.
BREAST FEEDING: Excreted into human milk.
The manufacturer does not consider this drug to be compatible with breast
feeding.
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Ranitidine
Treatment of peptic disorders, Antihistamine (H2 Receptor Antagonist)
CATEGORY:B
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS: Reduces gastric
acidity
CERCA LETTERATURA
Reserpine
Antihypertensive Agent
CATEGORY:C
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:Galactorrhea
CERCA LETTERATURA
Rifampin
Antituberculosis Agent
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Risperidone
Antipsychotic, Antimanic
CATEGORY: C
BREAST FEEDING:
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Rofecoxib
Nonsteroidal Anti-Inflammatory, cyclooxygenase-2 inhibitor
CATEGORY: C
Animal studies showed a treatment dependent decrease in the diameter of the ductus arteriosus. No delay in labor or parturition was seen.
There is no data on the use of rofecoxib during human pregnancy.
BREAST FEEDING:
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Salmeterol xinafoate
Salmeterol xinafoate (Serevent Diskus ®)
Bronchodilator, inhaled ß 2-agonist. Molecular weight:603.8
CATEGORY:
C
Among 47 infants whose mothers used salmeterol during early pregnancy, one case
of Aarskog syndrome (short stature, musculoskeletal, and genital anomalies) was
reported which was unlikely to be associated with salmeterol exposure [1].
Preliminary data from The Organization of Teratology Information Services (OTIS)
prospective cohort study of asthma medications in pregnancy did not support an
association between salmeterol and major malformations, growth disturbances,
spontaneous abortion, premature delivery, or preeclampsia. The OTIS study
compared the outcomes of 126 mothers who used salmeterol during pregnancy
( 90% had used the drug during first trimester) with 91 mothers who used only
short-acting beta agonists and 115 non-asthmatic women. Malformations in the
salmeterol group included 1 case of bicuspid aorta with penoscrotal fusion, 1
case of bilateral and 3 cases of unilateral inguinal hernia [2].
The American College of Obstetricians and Gynecologists (ACOG) and The
American College of Allergy, Asthma and Immunology (ACAAI) would not recommended
salmeterol for use during pregnancy in preference to older ß 2-agonists,
cromolyn or beclomethasone. However, salmeterol may be beneficial for patients
who have moderate-severe asthma and have shown a good response to this drug
prior to pregnancy [3].
BREAST FEEDING: "Since there are no data from controlled trials on the use
of salmeterol xinafoate by nursing mothers, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother. Plasma levels of salmeterol after inhaled
therapeutic doses are very low. Caution should be exercised when salmeterol
xinafoate is administered to a nursing woman"[4].
SEARCH
LITERATURE
1. Wilton LV, Pearce GL, Martin RM, Mackay FJ, Mann RD. The
outcomes of pregnancy in women exposed to newly marketed drugs in general
practice in England. Br J Obstet Gynaecol. 1998;105:882-9. MEDLINE
2. Jones KL et al. Salmeterol Use and Pregnancy Outcome: A Prospective
Multi-Center Study. American Academy of Allergy, Asthma and Immunology 58th
annual meeting. New York, New York, USA. March 1-6, 2002. J Allergy Clin Immunol.
[Abstract] 2002 ;109:S21-446. MEDLINE
3. The use of newer asthma and allergy medications during pregnancy. Position
Statement. The American College of Obstetricians and Gynecologists (ACOG) and
The American College of Allergy, Asthma and Immunology (ACAAI). Ann Allergy
Asthma Immunol. 2000;84:475-480. MEDLINE
4. Serevent® Diskus® package insert, GlaxoSmithKline.2003 .
Secobarbital
CATEGORY:D
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Withdrawal
CERCA LETTERATURA
Sertraline
Antidepressant. Selective serotonin reuptake inhibitor (SSRI). Molecular
weight:342.7
CATEGORY:C
"Reproduction studies have been performed in rats and rabbits at doses
up to 80 mg/kg/day and 40 mg/kg/day, respectively. These doses correspond to
approximately 4 times the maximum recommended human dose (MRHD) on a mg/m 2
basis. There was no evidence of teratogenicity at any dose level.
When pregnant rats and rabbits were given sertraline during the period of
organogenesis, delayed ossification was observed in fetuses at doses of 0.5
times the MRHD in rats and 4 times the MRHD in rabbits. When female rats
received sertraline at a dose of 20 mg/kg (1 times the MRHD) during the last
third of gestation and throughout lactation, there was an increase in the
number of stillborn pups and in the number of pups dying during the first 4
days after birth." [1].
Transplacental passage in humans has been demonstrated with a mean ratio
of cord to maternal serum concentration of 0.29 (range 0.10 to 0.66) after
maternal doses of 25 to 150 mg day [2].
A prospective study of women followed by The California Teratogen
Information Service found no increase in the rate of major anomalies in the
infants of 112 women who had used sertraline during pregnancy when
compared to nonexposed controls. Anomalies reported in the sertraline
exposed group included bilateral choanal atresia, valvular pulmonic stenosis
with an atrial septal aneurysm, unilateral club foot, and Down syndrome in a
pregnancy that was terminated. Infants exposed to sertraline during
the third trimester were more likely than controls to have neonatal
transition difficulties and were more often admitted to a special care
nursery [3]
Kulin NA et. al. prospectively examined 147 women who reported use of
sertraline during the first trimester pregnancy. The rates of miscarriage,
stillbirth, prematurity, mean birth weight, and major malformations in the
women who used sertraline were comparable to unexposed controls. Most of the
women had taken 50 mg daily (range 25-250 mg/d) [4] .
Hendrick V, et. al. found no increased rate of congenital anomalies in a
group of 36 women who had received sertraline therapy at any time during
pregnancy. Reported complications included three newborns admitted to the
special care nursery because of transient tachypnea of newborn, and another
infant admitted to special care because of esophageal perforation during
mouth suctioning [5].
BREAST FEEDING: Sertraline and its active metabolite
desmethylsertraline are excreted into breast milk.
A study of fifteen nursing women taking sertraline (25-200 mg/day)
found the milk/plasma ratio to be highly variable (range, 0.42-4.81). The
highest concentrations of sertraline and desmethylsertraline were observed 8
to 9 hours after maternal ingestion[6].
In another study of eight women taking sertraline the milk/plasma ratios
of 1.93 and 1.64 were estimated for sertraline and N-desmethylsertraline
respectively. Infant exposure calculated from estimated milk production
(0.15 l kg(-1) day(-1)), was estimated to be 0.90% and 1.32% for
sertraline and N-desmethylsertraline respectively [7].
Hendrick V et. al. , found no detectable medication (parent and/or
metabolite) present in the majority of (25/33) the serum samples
obtained from 30 infants exposed to sertraline through breast-feeding.
Sertraline was significantly more likely to be detected in an infant if the
mother's daily dose was 100 mg or higher [8].
The American Academy of Pediatrics has classified sertraline as a drug
"for which the effect on nursing infants is unknown but may be of
concern" [9].
NEONATAL SIDE EFFECTS:
Nystagmus has been observed in the newborn of a mother who had been
taking sertraline 50 mg daily for the two weeks preceding delivery. The
nystagmus resolved by 72 hours postpartum [10].
As previously mentioned, Chambers CD, et. al. found infants who had been
exposed to sertraline during the third trimester were more likely than
controls to have neonatal transition difficulties and more likely to be
admitted to a special care nursery [3].
One case report described "...agitation, restlessness, poor
feeding, constant crying, insomnia and enhanced startle reaction."
after abrupt cessation of breast feeding in an infant whose mother had been
taking the maximum recommended daily dose of 200 mg daily [1] throughout
most of her pregnancy and during lactation. Symptoms were persistent for 48
hours and subsided over next few days [11].
In contrast to the above case report, Hendrick V et. al. did not observe
symptoms suggesting neonatal withdrawal in 11 infants after prenatal
exposure to sertraline at doses of 25 to 150 mg per day [2].
SEARCH
LITERATURE
1. Physicians
Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2003: 2678-80.
2.Hendrick V, et. al. Placental passage of antidepressant medications. Am J
Psychiatry. 2003;160:993-6. MEDLINE
3. Chambers CD, et. al. Pregnancy outcome in women who use sertraline.
Teratology 1999;59:376.
4. Kulin NA, et al: Pregnancy outcome following maternal use of the new
selective serotonin reuptake inhibitors: a prospective controlled
multicenter study. JAMA. 1998;279:609-10. MEDLINE
5. Hendrick V et al. Birth outcomes after prenatal exposure to
antidepressant medication. Am J Obstet Gynecol. 2003;188:812-5.MEDLINE
6. Stowe ZN, et al. The pharmacokinetics of sertraline excretion into human
breast milk: determinants of infant serum concentrations. J Clin Psychiatry.
2003 ;64:73-80.MEDLINE
7. Kristensen JH, et al. Distribution and excretion of sertraline and
N-desmethylsertraline in human milk. Br J Clin Pharmacol. 1998;45:453-7.MEDLINE
8. Hendrick V, et al. Use of sertraline, paroxetine and fluvoxamine by
nursing women.Br J Psychiatry. 2001;179:163-6. MEDLINE
9.American
Academy of Pediatrics Committee on Drugs: Transfer of drugs and other
chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89.
10. Oca MJ, Donn SM. Association of maternal sertraline (Zoloft) therapy and
transient neonatal nystagmus. J Perinatol. 1999;19:460-1.MEDLINE
11. Kent LS and Laidlaw JD. Suspected congenital sertraline dependence.[Letter]
Br J Psychiatry. 1995;167:412-3. MEDLINE
ADDITIONAL READING (Patient oriented): Zoloft
(sertraline) and Pregnancy (PDF file) 
2002 Organization of Teratology Information Services
Simethicone
Defoaming agent used to relieve flatulence. Mixture of
dimethyl polysiloxanes and silica gel. Molecular weight between 14,000 and
21,000
CATEGORY:
C
A study in volunteers measuring silicon in the blood (as the surrogate marker
for simethicone) noted that blood and urine levels of silicone were similar at
baseline and after receiving a simethicone-coated cellulose suspension (SonoRx®
)or vehicle control. This suggests minimal systemic absorption of simethicone
[1].
SEARCH
LITERATURE
1. SonoRx®
product label, 1998.
Simvastatin
Antilipemic Agent, HMG-CoA reductase inhibitor
CATEGORY:X
Inadvertent exposure in 134 pregnancies to lovastatin or simvastatin resulted in no increased risk of anomaly [1].
BREAST FEEDING:
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
1. Manson JM,et al.Postmarketing surveillance of lovastatin and simvastatin exposure during pregnancy.Reprod Toxicol; 10,439,1996 MEDLINE
Sulbactam
CATEGORY:B
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Spironolactone
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Sulfapyridine/sulfisoxazole
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Caution in infant with jaundice or G-6-PD deficiency and ill, stressed, or premature infant.
CERCA LETTERATURA
Sulfasalazine
CATEGORY:B
BREAST FEEDING: With caution.[G3].
NEONATAL SIDE EFFECTS: Bloody diarrhea.
CERCA LETTERATURA
Sumatriptan
CATEGORY:C
BREAST FEEDING: Negligible excretion
into breast milk. Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Technitium-99m
CATEGORY:X
BREAST FEEDING: Contraindicated Radioactivity
in milk for 3 days
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Temazepam
CATEGORY:X
Stillbirth has been reported following the use of diphenhydramine and temazepam in combination during human pregnancy [G1 ].
BREAST FEEDING: The American Academy of Pediatrics has classified temazepam as a drug "for which the effect on nursing infants is unknown but may be of concern" [G3].
NEONATAL SIDE EFFECTS: Irritability
CERCA LETTERATURA
Terbinafine
Antifungal
CATEGORY:B
BREAST FEEDING: Excreted into breast milk. Contraindicated.
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Terbutaline
CATEGORY:B
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Agitation and
vomiting
CERCA LETTERATURA
Terfenadine
Anihistamine. Molecular weight:471.68
Terfenadine was removed from the marketplace in the United States in 1998
after the approval of a safer alternative drug Allegra
(fexofenadine hydrochloride). Fexofenadine hydrochloride provides the same
benefits of terfenadine, but appears to have less potential for the cardiac
toxicity of terfenadine.
CATEGORY:C
[1]
Studies performed in pregnant rats and rabbits at daily oral doses up to 300
mg/kg/day were not teratogenic in either rats or rabbits [2].
Briggs et. al. reported on data from a surveillance study of Michigan
Medicaid recipients conducted between 1985 and 1992. Amongst 1,034 newborns who
had been exposed to terfenadine during the first trimester there were 12 cases
of polydactyly (3 cases were expected). The data did not otherwise support
an association between terfenadine and major malformations (cardiovascular
defects, oral clefts, spina bifida, limb reduction defects, and hypospadias)
[1].
Schick et al. compared the outcomes of 125 mothers who used terfenadine
during early pregnancy with a matched control group. There was no significant
difference in adverse pregnancy outcomes between the two groups [3].
In a multicenter prospective study of one hundred eighteen women exposed to
terfenadine during pregnancy 65 women were exposed to terfenadine during the
first trimester. Among women exposed during the first trimester rates of major
malformations in the terfenadine group did not differ from rates in matched
control subjects. Gestational age at delivery, rates of preterm deliveries,
and developmental milestones were comparable between the groups. Although the
birth weight in the terfenadine-exposed newborns was significantly lower
compared with that in their matched control subjects the rate of small for
gestational age infants was not different between the groups [4]
The Israeli Teratogen Information Service prospectively identified two birth
defects (one child with congenital hip dysplasia and one with bilateral inguinal
hernia) amongst 27 pregnancies exposed to terfenadine during the first trimester.
The authors of the study reported that the rate of anomalies was not
significantly different from that of a control group with nonteratogenic
exposures[5].
BREAST FEEDING: In a study of four healthy lactating
mothers subjects received 60 mg terfenadine every 12 hours over a period of 48
hours. Terfenadine was not detected in milk or plasma. However, fexofenadine
(the active metabolite of terfenadine) was found in milk and plasma.
The AUCmilk/AUCplasma (0-12) ratio for fexofenadine was
0.21 (range 0.12 to 0.28)
Newborn dosage estimates based on the highest measured concentration of
fexofenadine in milk suggest the maximum level of newborn exposure would not
exceed 0.45% of the recommended maternal weight-corrected dose [6]
SEARCH
LITERATURE
1. Briggs GG,Freeman RK, Yaffe SJ, Drugs in
Pregnancy and Lactation 6th edition,Baltimore, MD: Williams
& Wilkins,2002 p 1321-22
2. Gibson JP et al. Preclinical safety studies with terfenadine.
Arzneimittelforschung. 1982;32:1179-84.MEDLINE
3. Schick B, et al. Terfenadine (Seldane) exposure in early pregnancy.
Teratology [Abstract] 1994;49:417.
4. Loebstein R, et al. Pregnancy outcome after gestational exposure to
terfenadine: A multicenter, prospective controlled study.J Allergy Clin Immunol.
1999 Nov;104(5):953-6. MEDLINE
5. Diav-Citrin O, et al. Pregnancy outcome after gestational exposure to
loratadine or antihistamines: a prospective controlled cohort study.J Allergy
Clin Immunol. 2003; 111: 1239-43. MEDLINE
6. Lucas BD, et al. Terfenadine pharmacokinetics in breast milk in lactating
women.Clin Pharmacol Ther. 1995;57:398-402. MEDLINE
Tetanus Toxoid
CATEGORY:
C
Inactivated toxin of Clostridium tetanus
No evidence exists to indicate that tetanus toxoid
administered during pregnancy are teratogenic [1,2]. The American College of
Obstetricians and Gynecologists recommends the use of tetanus/diptheria
toxoids in pregnant women at risk of acquiring disease or in women who have
not recieved a booster within the past ten years [3].
BREAST FEEDING: Compatible [4].
SEARCH
LITERATURE
1. Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and
Other Preventive Measures Recommendations of the Immunization Practices Advisory
Committee (ACIP) Morbidity
and Mortality Weekly Report August 08, 1991 / 40(RR10);1-28
2. Silveira CM, Caceres VM, Dutra MG et al: Safety of tetanus toxoid in pregnant
women: A hospital-based case-control study of congenital anomalies. Bull WHO
73:605-608, 1995.MEDLINE
3. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003
;101:207-12. MEDLINE
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the
Eleventh WHO Model list of Essential Drugs. pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file) 
Tetracycline
Antibiotic. Molecular weight:444.44
CATEGORY:
D
Tetracycline-induced hepatotoxicity and hepatorenal failure have been
reported in pregnant women given tetracycline [1-3]
Results of The Collaborative Perinatal Project found no increase in the
incidence of major malformations among 341 mother-child pairs exposed during the
first trimester to tetracycline. However, the findings of the study suggested a
possible association with minor defects (inguinal hernia, hypoplasia of a limb,
and hypospadias)[4].
A surveillance study of Michigan Medicaid recipients reported that data on
1004 newborns exposed to tetracycline during the first trimester did not support
an association between tetracycline and major malformations, specifically
cardiovascular defects, oral clefts, spina bifida, polydactyly, limb reduction
defects, and hypospadias [5].
Tetracycline exposure after the fourth month of pregnancy may result in
brownish staining of the deciduous teeth. When administered near term the
permanent teeth may also be a stained [6].
BREAST FEEDING: The American Academy of Pediatrics has classified
tetracycline as a medication "usually compatible with breast feeding"
[7]. The WHO Working Group on Human Lactation considered the risk to the infant
to be slight when tetracycline is used for less than 10 days [8].
NEONATAL SIDE EFFECTS: Oral tetracycline given to premature infants has been
associated with decreased growth of the fibula . The effect was reversible
after the drug was discontinued [9].
SEARCH
LITERATURE
1. Pride GL, et al. Disseminated intravascular coagulation associated with
tetracycline-induced hepatorenal failure during pregnancy. Am J Obstet Gynecol.
1973;115:585-6. available. MEDLINE
2. Allen ES, et al.Hepatic toxicity of tetracycline in pregnancy.Am J Obstet
Gynecol. 1966;95:12-8. MEDLINE
3. Whalley PJ, et al. Disposition of tetracycline by pregnant women with acute
pyelonephritis.Obstet Gynecol. 1970;36:821-6. MEDLINE
4. Heinonen OP et al: Birth Defects and Drugs in Pregnancy Littleton, Publishing
Sciences Group, 1977, pp 472-486.
5. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore,
MD: Williams
& Wilkins,2002 p 1325.
6. Shepard TH. Catalog of Teratogenic Agents pp 1309. 9th ed.Baltimore, MD: Johns
Hopkins University Press, 1998 .p2553
7. Transfer
of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89.
Review.
8.The
WHO Working Group, Bennet PN (ed).: Drugs and Human Lactation. Elsevier,
Amsterdam, New York, Oxford, 1988.
9. Cohlan SQ et al.Growth inhibition of prematures receiving tetracycline. Am
J Dis Child 1963;105:453-461.
Theophylline
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Irritability
CERCA LETTERATURA
Thioridazine
CATEGORY:C
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Thyroid hormone
CATEGORY:A
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Ticarcillin
CATEGORY:B
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Diarrhea
CERCA LETTERATURA
Timolol
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:Hypotension,bradycardia
CERCA LETTERATURA
Tinidazole
CATEGORY:C
BREAST FEEDING: The American Academy of Pediatrics has classified tinidazole as a drug
"for which the effect on nursing infants is unknown but may be of concern" [G3].
CERCA LETTERATURA
NEONATAL SIDE EFFECTS: See
Metronidazole
Tobramycin
CATEGORY:D
BREAST FEEDING:
NEONATAL SIDE EFFECTS: Diarrhea
CERCA LETTERATURA
Tolbutamide
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS: Jaundice, hypoglycemia
CERCA LETTERATURA
Tolmetin
CATEGORY:C
See NSAIDS
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Topiramate
CATEGORY:C
Tramadol
CATEGORY:C
No human data. Transient developmental
delay seen in animal studies.
BREAST FEEDING: Not recommended. Excreted
into breast milk in high concentrations.
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Trazodone
Antidepressant. Molecular weight:408.33.
CATEGORY:C
[1]
In a studies performed on rats and rabbits no teratogenic effects were
found at doses of up to 210 and 75 mg per kg respectively [2].
A surveillance study of Michigan Medicaid recipients reported that data
on 100 newborns exposed to trazodone during the first trimester did not
support an association between trazodone and major malformations,
specifically hypospadias, cardiovascular defects, limb reduction
defects, oral clefts, polydactyly, and spina bifida [1].
Einarson A, et al found
no increased rate in major malformations in 58 pregnancies after first
trimester exposure to trazodone [3].
BREAST FEEDING: The excretion of breast milk was studied in six
lactating women following the oral administration of a single trazodone
tablet (50 mg). The milk/plasma ratio of trazodone was 0.14 [4].
The American Academy of Pediatrics has classified trazodone as a
medication "for Which the Effect on Nursing Infants Is Unknown but May
Be of Concern" [5]
SEARCH
LITERATURE
1. Briggs GG,Freeman RK, Yaffe SJ, Drugs in
Pregnancy and Lactation 6th edition,Baltimore, MD: Williams
& Wilkins,2002 p 1374-1375
2. Barcellona PS. Investigations on the possible teratogenic effects of
trazodone in rats and rabbits. Boll Chim Farm. 1970;109:323-32. MEDLINE
3. Einarson A, et al. A multicentre prospective controlled study to
determine the safety of trazodone and nefazodone use during pregnancy.Can J
Psychiatry. 2003;48:106-10.MEDLINE
4. Verbeeck RK et al.Excretion of trazodone in breast milk.Br J Clin
Pharmacol. 1986;22:367-70.MEDLINE
5. Transfer
of drugs and other chemicals into human milk. Pediatrics. 2001 ;108:776-89.
Triamcinolone acetonide
Corticosteroid, Inhalation Aerosol
CATEGORY:C
BREAST FEEDING:
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Triamterene
Antihypertensive, Diuretic
CATEGORY:C
1st trimester exposure in 318 infants resulted in no increase in major or minor anomalies.
BREAST FEEDING: Contraindicated.
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Trifluoperazine
Tranquilizer
CATEGORY:C
BREAST FEEDING: The American Academy of Pediatrics has classified trifluoperazine as a drug "for which the effect on nursing infants is unknown but may be of concern" [G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Trimethobenzamide
Antiemetic
CATEGORY:C
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Trimethoprim/sulfamethoxazole
Anti-Infective
CATEGORY:C
Folic acid antagonists, which include
such common drugs as trimethoprim, triamterene, carbamazepine, phenytoin,
phenobarbital, and primidone, may increase the risk not only of neural-tube
defects, but also of cardiovascular defects, oral clefts, and urinary tract
defects.
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
1.
Czeizel AE, et al
The teratogenic risk of trimethoprim-sulfonamides: a population based
case-control study.
Reprod Toxicol. 2001 Nov-Dec;15(6):637-46.
PMID: 11738517
MEDLINE
Hernandez-Diaz SFolic acid antagonists during pregnancy and the risk
of birth defects.
N Engl J Med. 2000 Nov 30;343(22):1608-14.
PMID: 11096168
Neural tube defects in relation to use of folic acid antagonists during
pregnancy.
Am J Epidemiol. 2001 May 15;153(10):961-8.
PMID: 11384952
Created: 11/17/2000
Last Update: 11/30/2002
Triprolidine
CATEGORY:C
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Troglitazone
Antidiabetic Agent
CATEGORY:B
BREAST FEEDING: Contraindicated.
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Vaccine,
Anthrax Adsorbed
CATEGORY:
D
Non-live vaccine.
"Preliminary results of a recent unpublished
retrospective study of infants born to women in the U.S. military service
worldwide in 1998 and 1999 suggest that the vaccine may be linked with an
increase in the number of birth defects when given during pregnancy (unpublished
data, Department of Defense). Although these data are unconfirmed, pregnant
women should not be vaccinated against anthrax unless the potential benefits of
vaccination have been determined to outweigh the potential risk to the fetus.
Animal reproduction studies have not been conducted with BioThrax."[1]. A
cohort study of US Army women found no effect on pregnancy and birth rates or
adverse birth outcomes in 385 pregnancies following at least 1 dose of anthrax
vaccine. However, this study did not have sufficient power to detect adverse
birth outcomes [2]. Not routinely recommended except in pregnant women work at
high risk for exposure [3].
BREAST FEEDING: Compatible [1,4].
SEARCH
LITERATURE
References
1.Bio ThraxTM package
insert 2002
2. Wiesen AR, Littell CT.Relationship between prepregnancy anthrax vaccination
and pregnancy and birth outcomes among US Army women.JAMA. 2002 Mar
27;287(12):1556-60.MEDLINE
3. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003
;101:207-12.MEDLINE
4. Centers for Disease Control & Prevention. Use of Anthrax Vaccine in the
United StatesRecommendations of the Advisory Committee on Immunization Practices
MMWR
49 (No. RR-15):1-20, 2000.
Vaccine, Cholera
CATEGORY:
C
Killed bacteria vaccine.
The effects of cholera vaccine on the developing fetus are
unknown. Cholera vaccine may be indicated in pregnancy when susceptibility and
exposure to cholera are highly probable such as may occur with travel to areas
where the disease is endemic or epidemic.[1].
BREAST FEEDING: Compatible [2].
SEARCH
LITERATURE
1. Immunization during pregnancy. ACOG technical bulletin number
160--October 1991. Int J Gynaecol Obstet. 1993 Jan;40(1):69-79. MEDLINE
2. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
Vaccine,Haemophilus
B Conjugate
CATEGORY:
C
Capsular polysaccharide vaccine.
No adverse effects were reported after third trimester
exposure in 50 pregnancies [1] .
BREAST FEEDING: Compatible[2].
SEARCH
LITERATURE
1. Englund JA, Glezen WP, Turner C, Harvey J, Thompson C, Siber GR.
Transplacental antibody transfer following maternal immunization with
polysaccharide and conjugate Haemophilus influenzae type b vaccines. J
Infect Dis 1995; 171: 99-105. MEDLINE
2. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
Vaccine,
Hepatitis A
CATEGORY:
C
Inactivated noninfectious vaccine.
The effects of hepatitis vaccine on the developing fetus are
unknown. However the theoretical risk to the fetus is low [1], and the vaccine
is considered safe for use during pregnancy [2, 3].
BREAST FEEDING: Compatible [4].
SEARCH
LITERATURE
1. Centers for Disease Control & Prevention. Prevention of Hepatitis
A Through Active or Passive Immunization: Recommendations of the Advisory
Committee on Immunization Practices (ACIP). MMWR 45 (No. RR-15): 20, 1996.
2. Duff B, Duff P.Hepatitis A vaccine: ready for prime time.Obstet Gynecol.
1998;91(3):468-71. MEDLINE
3. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol.
2003 ;101:207-12.MEDLINE
4. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994. Glaxo SmithKline
Hepatitis A vaccination pregnancy registry – 888-825-5249
Vaccine,
Hepatitis B
CATEGORY:
C.
Inactivated (recombinant) noninfectious vaccine.
Pregnancy and lactation are not contraindications to vaccine
[1].The American College of Obstetricians and Gynecologists recommends the use
of hepatitis B vaccine for pregnant women at risk of acquiring the disease [2].
BREAST FEEDING: Compatible [3,4].
SEARCH
LITERATURE
REFERENCES
1. Centers for Disease Control & Prevention. Hepatitis B Virus: A
Comprehensive Strategy for Eliminating Transmission in the United States Through
Universal Childhood Vaccination: Recommendations of the Immunization Practices
Advisory Committee (ACIP). MMWR 40 (No. RR-13): 4, 1991.
2. ACOG Committee Opinion.
Immunization during pregnancy.Obstet Gynecol. 2003;101:207-12.MEDLINE
3. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the
Eleventh WHO Model list of Essential Drugs. pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)
Vaccine,
Influenza
CATEGORY:
C
Inactivated virus vaccine.
Studies of influenza immunization of more than 2,000 pregnant
women have demonstrated no adverse fetal effects associated with influenza
vaccine. Pregnancy and lactation are not contraindications [1]. The vaccine is
recommended by the American College of Obstetricians and Gynecologists "
...in the second and third trimester during the flu season, and women at
high risk for pulmonary complications regardless of the trimester."[2].
BREAST FEEDING: Compatible [3,4].
SEARCH
LITERATURE
1. Centers for Disease Control & Prevention. Prevention and Control
of Influenza: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 47 (No. RR-6): 6, 1998.
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol.
2003 ;101:207-12.MEDLINE
3.Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4. Breastfeeding and Maternal Medication.
Recommendations for Drugs in the Eleventh WHO Model list of Essential Drugs.
pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland (PDF
file)
Vaccine,
Measles
CATEGORY:X
Live attenuated virus vaccine.
Contraindicated in pregnancy [1]. Avoid becoming pregnant for
30 days after vaccination with measles containing vaccines [2].
BREAST FEEDING: Compatible[3,4]
SEARCH
LITERATURE
1. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol.
2003 ;101:207-12.MEDLINE
2. Centers for Disease Control & Prevention. Measles, Mumps, and Rubella
— Vaccine Use and Strategies for Elimination of Measles, Rubella, and
Congenital Rubella Syndrome and Control of Mumps: Recommendations of the
Immunization Practices Advisory Committee (ACIP). MMWR 47 (No. RR-8): 32-33,
1998.
3. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the
Eleventh WHO Model list of Essential Drugs. pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)
Vaccine,
Meningococcus
CATEGORY:
C
Killed bacteria vaccine.
Studies have shown the vaccine to be both safe and
efficacious when given to pregnant women [1]. The American College of
Obstetricians and Gynecologists does not consider the indications for the
vaccine to be altered by pregnancy [2].
BREAST FEEDING: Compatible[3,4].
SEARCH
LITERATURE
1. Centers for Disease Control & Prevention. Control and Prevention
of Meningococcal Disease and Control and Prevention of Serogroup C
Meningococcal Disease: Evaluation and Management of Suspected Outbreaks:
Recommendations of the Advisory Committee on Immunization Practices (ACIP).
MMWR 46 (No. RR-5): 5, 1997.
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol.
2003 Jan;101(1):207-12.MEDLINE
3. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the
Eleventh WHO Model list of Essential Drugs. pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)
Vaccine,
Mumps
CATEGORY:X
Live attenuated virus vaccine.
Mumps virus has been been recovered from the placenta , but
not from the fetal tissues of three susceptible pregnant women who were
vaccinated before undergoing elective abortions. However, the sample size is too
small to rule out the possibility of fetal mumps infection after vaccination
with mumps live attenuated virus [1]. The vaccine is considered to be
contraindicated in pregnancy by the American College of Obstetricians and
Gynecologists [2]. Avoid becoming pregnant for 30 days after vaccination with
mumps containing vaccines [3]
BREAST FEEDING: Compatible [4,5].
SEARCH
LITERATURE
1.Yamauchi T, Wilson C, Geme JW
Jr. Transmission of live, attenuated mumps virus to the human placenta. N
Engl J Med. 290:710-2, 1974 MEDLINE
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol.
2003 ;101:207-12.MEDLINE
3. Centers for Disease Control & Prevention. Measles, Mumps, and Rubella
- Vaccine Use and Strategies for Elimination of Measles, Rubella, and
Congenital Rubella Syndrome and Control of Mumps: Recommendations of the
Immunization Practices Advisory Committee (ACIP). MMWR 47 (No. RR-8): 32-33,
1998.
4. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
5.Breastfeeding and Maternal Medication. Recommendations for Drugs in the
Eleventh WHO Model list of Essential Drugs. pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)
Vaccine, Plague
CATEGORY:
C
Killed bacteria vaccine.
The effects of plague vaccine on the developing fetus are
unknown. Vaccine should be used only if the potential benefits of vaccination
outweigh potential risks to the fetus[1].
BREAST FEEDING: Compatible [2].
SEARCH
LITERATURE
1. Centers for Disease Control & Prevention. Prevention of Plague:
Recommendations of the Advisory Committee on Immunization Practices (ACIP).
MMWR 45 (No. RR-14): 10, 1996.
2. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
Vaccine,
Pneumococcal
CATEGORY:
C
Killed bacteria vaccine.
No adverse outcomes have been reported among newborns whose
mothers were vaccinated during pregnancy [1,2] The American College of
Obstetricians and Gynecologists does not consider the indications for the
vaccine to be altered by pregnancy. The vaccine is recommended for women with
asplenia, metabolic, renal, cardiopulmonoary diseases, smokers and
immunosuppressed patients[3].
BREAST FEEDING: Compatible [4].
SEARCH
LITERATURE
1. Centers for Disease Control & Prevention. Prevention of
Pneumococcal Disease: Recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR 46 (No. RR-8): 6, 1997.
2. Shahid NS, Steinhoff MC, et. al., Serum, breast milk, and infant antibody
after maternal immunisation with pneumococcal vaccine.Lancet. 1995 Nov
11;346(8985):1252-7.MEDLINE
3. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol.
2003 ;101:207-12.MEDLINE
4. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
Vaccine, Poliovirus
Inactivated
CATEGORY:
C
Inactivated virus vaccine.
No adverse effects have been reported among pregnant women or
their fetuses. However, vaccine should be used only if the potential benefits of
vaccination outweigh potential risks to the fetus[1]. Recommended for women at
increased risk of exposure [2].
BREAST FEEDING: Compatible[3,4].
SEARCH
LITERATURE
1. Centers for Disease Control & Prevention. Poliomyelitis Prevention in
the United States: Introduction of a Sequential Vaccination Schedule of
Inactivated Poliovirus Vaccine Followed by Oral Poliovirus Vaccine:
Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR
46 (No. RR-3): 18, 1997.
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003
;101:207-12.MEDLINE
3. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the
Eleventh WHO Model list of Essential Drugs. pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)
Vaccine, Poliovirus
Live
CATEGORY:
C
Live trivalent attenuated virus bacteria vaccine.
No adverse effects have been reported among pregnant women or
their fetuses. However, vaccine should be used only if the potential benefits of
vaccination outweigh potential risks to the fetus[1]. Recommended for women at
increased risk of exposure [2].
BREAST FEEDING: Compatible[3].
SEARCH
LITERATURE
1. Centers for Disease Control & Prevention. Poliomyelitis Prevention in
the United States: Introduction of a Sequential Vaccination Schedule of
Inactivated Poliovirus Vaccine Followed by Oral Poliovirus Vaccine:
Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR
46 (No. RR-3): 18, 1997.
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003
;101:207-12.MEDLINE
3. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
Vaccine,
Rabies
CATEGORY:
C
Inactivated virus vaccine.
Pregnancy is not considered a contraindication to
postexposure prophylaxis [1,2 ]
BREAST FEEDING: Compatible [3,4].
SEARCH
LITERATURE
1. Centers for Disease Control & Prevention. Rabies Prevention–United
States, 1991: Recommendations of the Immunization Practices Advisory
Committee (ACIP). MMWR 40 (No. RR-3): 11-12, 1991.
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol.
2003 ;101:207-12.MEDLINE
3. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the
Eleventh WHO Model list of Essential Drugs. pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)
Vaccine,
Rubella
CATEGORY:
C
Live attenuated virus vaccine.
No evidence of congenital rubella syndrome occurred in
the offspring of the 226 women who received the current RA 27/3 rubella
vaccine and continued their pregnancy to term. Nonetheless women should be
counseled to avoid becoming pregnant for 28 days after exposure to
rubella-containing vaccines [1,2].
BREAST FEEDING: Excreted into human milk. Recent studies have shown that
lactating postpartum women immunized with live attenuated rubella vaccine
may secrete the virus in breast milk and transmit it to breast-fed infants.
In the infants with serological evidence of rubella infection, none
exhibited severe disease; however, one exhibited mild clinical illness
typical of acquired rubella. Caution should be exercised when MERUVAX II is
administered to a nursing woman [3]. Compatible with breastfeeding [4,5].
SEARCH
LITERATURE
1.Centers for Disease Control & Prevention. Measles, Mumps, and
Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella,
and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the
Immunization Practices Advisory Committee (ACIP). MMWR 47 (No. RR-8): 32-33,
1998.
2. Revised
ACIP Recommendation for Avoiding Pregnancy After Receiving a
Rubella-Containing Vaccine
MMWR 50(49);1117, 2001
3.MeruvaxII® vaccine package insert, 2001.
4. Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
5.Breastfeeding and Maternal Medication. Recommendations for Drugs in the
Eleventh WHO Model list of Essential Drugs. pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)
Vaccine,TC-83 Venezuelan Equine Encephalitis
FDACategories.htm">CATEGORY:X
[1]
Live attenuated virus vaccine.
Avoid pregnancy for 3 months following vaccination.
BREAST FEEDING: Compatible [2].
SEARCH
LITERATURE
1. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore,
MD: Williams
& Wilkins,2002 p 1431-1433.
2. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
Vaccine,
Typhoid
CATEGORY:
C
Killed bacteria vaccine.
1st trimester exposure to the oral vaccine in 18 pregnancies
resulted in two miscarriages (2.7 expected) and 16 normal infants. However, the
sample size is too small to draw firm conclusions [1]. Typhoid vaccine may be
indicated in pregnancy when susceptibility and exposure to typhoid are highly
probable such as may occur with travel to areas where the disease is endemic or
epidemic [2]. The oral vaccine is preferred [3].
BREAST FEEDING: Compatible [4,5].
SEARCH
LITERATURE
1. Mazzone T, Celestini E, Fabi R, Pagano M, Serafini MA, Verdecchia P,
Mastroiacovo P. Oral typhoid vaccine and pregnancy. Reprod Toxicol 8:278-9,
1994. MEDLINE
2. Immunization during pregnancy. ACOG technical bulletin number 160--October
1991. Int J Gynaecol Obstet. 1993 Jan;40(1):69-79. MEDLINE
3. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003
;101:207-12.MEDLINE
4. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
5.Breastfeeding and Maternal Medication. Recommendations for Drugs in the
Eleventh WHO Model list of Essential Drugs. pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)
Vaccine,
Vaccinia - Smallpox
CATEGORY:C
[Manufacturer]
CATEGORY:X [1]
Live attenuated virus vaccine.
Vaccinia should not be administered to pregnant women for
routine nonemergency indications. Although vaccinia vaccine is not known to
cause congenital malformations primary vaccination with vaccinia virus has been
reported to cause fetal infection. Fetal vaccinia usually results in stillbirth
or death of the infant shortly after delivery. [2,3,4]
There are no absolute contraindications regarding vaccination
of a person with a high-risk exposure to smallpox.
BREAST FEEDING: It is not known whether vaccine antigens or
antibodies are excreted in human milk. This vaccine is not recommended for use
in a nursing mother in non-emergency conditions [2, 4].
SEARCH
LITERATURE
1. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 5th
edition,Baltimore, MD: Williams
& Wilkins,1998
2. Centers for Disease Control & Prevention. Vaccinia (Smallpox) Vaccine
Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2001
MMWR
50 (No. RR-10): 1-25, 2001.
3. Levine MM. Live-virus vaccines in pregnancy. Risks and recommendations.
Lancet. 1974 ;2:34-8. MEDLINE
4. Dryvax ® package
insert 2002
Vaccine,Varicella
CATEGORY:
C
Live attenuated virus vaccine.
No cases of congenital varicella syndrome were identified
after first and second trimester exposure among 56 live births, but the sample
size is too small to draw firm conclusions [1] .The American College of
Obstetricians and Gynecologists considers the vaccine to be contraindicated
during pregnancy [2]. Nonpregnant women who are vaccinated should avoid becoming
pregnant for 1 month following each injection [3].
BREAST FEEDING: Compatible [4].
SEARCH
LITERATURE
1. Shields KE, Galil K, Seward J, Sharrar RG, Cordero JF, Slater E. Varicella
vaccine exposure during pregnancy: data from the first 5 years of the pregnancy
registry. Obstet Gynecol. 2001 Jul;98(1):14-9.MEDLINE
2. ACOG Committee Opinion. Immunization during pregnancy.Obstet Gynecol. 2003
;101:207-12.MEDLINE
3.Centers for Disease Control & Prevention. Prevention of Varicella:
Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR
45 (No. RR-11): 19, 1996.
4. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
Vaccine, Yellow
Fever
CATEGORY:
D
Live attenuated virus vaccine.
Robert E, et al. reported on women who had received yellow
fever vaccine (YFV) during early pregnancy. Of 58 pregnancies with completed
follow-up five ended in voluntary abortions, seven in spontaneous abortion, and
46 births. Three newborns had minor anomalies and two had major defects (ureteral
stenosis and triphalangeal hallux)[1].
Women who must travel to areas where the risk of yellow fever
is high should be vaccinated. However if a travel requirement is the only reason
for vaccination, then efforts should be made to obtain a waiver letter from the
traveler’s physician [2].
BREAST FEEDING: Compatible [3, 4].
SEARCH
LITERATURE
1. Robert E , et al.,Exposure to yellow fever vaccine in early pregnancy.
Vaccine. 1999 ;17:283-5.MEDLINE
2. Centers for Disease Control & Prevention. Yellow Fever Vaccine:
Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 39
(No. RR-6): 3, 1990.
3. Centers for Disease Control & Prevention. General Recommendations on
Immunization: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 43 (No. RR-1): 20-21, 1994.
4.Breastfeeding and Maternal Medication. Recommendations for Drugs in the
Eleventh WHO Model list of Essential Drugs. pp 23-24 World
Health Organization, 2002. 20 Avenue Appia ,1211 Geneva ,Switzerland
(PDF file)
Valproic
acid
CATEGORY:D
Incidence of neural tube defect (spina bifida) after first trimester exposure is approximately 1% [1].
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:Hepatitis,hemorrhagic
pancreatitis
CERCA LETTERATURA
1.Teratology. ACOG technical bulletin number 236--April 1997
Vancomycin
CATEGORY:C
BREAST FEEDING:
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Vegetarian
Diet
-
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:B12 deficiency
CERCA LETTERATURA
Venlafaxine
Antidepressant .Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV),
are potent inhibitors of neuronal serotonin and norepinephrine reuptake and weak
inhibitors of dopamine reuptake.
Molecular weight: 313.87. The degree of plasma
protein binding of venlafaxine
is approximately 27% at concentrations ranging from 2.5 to 2215 ng/mL. The
degree of plasma protein binding of ODV
is approximately 30% at concentrations ranging from 100 to 500 ng/mL [1].
CATEGORY:C
"Venlafaxine did not cause malformations in offspring of rats or rabbits
given doses up to 11 times (rat) or 12 times (rabbit) the maximum recommended
human daily dose on a mg/kg basis, or 2.5 times (rat) and 4 times (rabbit) the
human daily dose on a mg/m 2 basis. However, in rats, there was a
decrease in pup weight, an increase in stillborn pups, and an increase in pup
deaths during the first 5 days of lactation, when dosing began during pregnancy
and continued until weaning. The cause of these deaths is not known. These
effects occurred at 10 times (mg/kg) or 2.5 times (mg/m 2 ) the
maximum human daily dose. The no effect dose for rat pup mortality was 1.4 times
the human dose on a mg/kg basis or 0.25 times the human dose on a mg/m 2 basis."[1]
Venlafaxine appears to cross the human placenta near term [2].
In a prospective study pregnancy outcomes of 150 women exposed to
venlafaxine during first trimester were compared with the pregnancy outcomes of
a group of pregnant women who received selective serotonin reuptake
inhibitor antidepressants and a group of women who received
nonteratogenic drugs. The majority of the women in the venlafaxine group took 75
mg/day (range 37.5 to 300 mg/day) of venlafaxine immediate release form. Among
the 150 women who were exposed to venlafaxine during pregnancy, 125 had live
births, 18 had spontaneous abortions and seven had therapeutic abortions; two of
the babies had major malformations. Birthweight, gestational age at delivery,
and the rate of major malformations did not differ amongst the three
groups [3].
The small
number of human pregnancies exposed to venlafaxine to date are insufficient
to allow a general conclusion regarding the teratogenic risk of venlafaxine.
BREAST FEEDING: Venlafaxine and its active metabolite, O-desmethylvenlafaxine
(ODV) are excreted into human milk. In a small case series of three lactating
women taking venlafaxine for depression the mean milk/plasma ratio for
venlafaxine was 4.1 (range 2.8-4.8) and 3.1 for ODV (range 2.8-3.8). The mean
total infant dose (as V equivalents) was 7.6% (range 4.7-9.2%) of the maternal
weight-adjusted dose, with approximately equal amounts of V (3.5%) and ODV
(4.1%) in the dose. Although ODV was detected in the plasma of all three infants
no adverse effects were noted in the infants [4].
Hendrick V, et al. also found ODV in the plasma of two breast fed infants
whose mothers were treated with venlafaxine 75 and 150 mg/day. Neither infant
experienced adverse effects from venlafaxine exposure through breast
milk, and their development appeared to be normal over the
first year [5].
NEONATAL SIDE EFFECTS: Restlessness, hypertonia, jitteriness, irritability and
poor feeding occurred in a neonate after maternal use of venlafaxine for
depression during pregnancy. The diagnosis was confirmed by a temporary
improvement after administration of a low dose (1 mg) of venlafaxine to the boy.
The symptoms ceased after 8 days [6].
SEARCH
LITERATURE
1. Physicians
Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2004: 3413-3415
2. Hostetter A, et al. Amniotic fluid and umbilical cord blood concentrations of
antidepressants in three women.Biol Psychiatry. 2000;48:1032-4.MEDLINE
3.Einarson A, et al.. Pregnancy outcome following gestational exposure to
venlafaxine: a multicenter prospective controlled study. Am J Psychiatry.
2001;158:1728-30. MEDLINE
4. Ilett KF, Hackett LP, Dusci LJ, Roberts MJ, Kristensen JH, Paech M, Groves A,
Yapp P. Distribution and excretion of venlafaxine and O-desmethylvenlafaxine in
human milk. Br J Clin Pharmacol. 1998;45:459-62. MEDLINE
5. Hendrick V, et al. Venlafaxine and breast-feeding.[Letter]Am J Psychiatry.
2001;158:2089-90. MEDLINE
6. de Moor RA et al. [Withdrawal symptoms in a neonate following exposure to
venlafaxine during pregnancy] Ned Tijdschr Geneeskd. 2003;147:1370-2. MEDLINE
Verapamil
CATEGORY:C
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Vitamin A
CATEGORY:A
CATEGORY:X in high doses.
High doses produce urogenital anomalies and defects similar to isotretinoin
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
ADDITIONAL READING: Vitamin A and Pregnancy
1996 Illinois Teratogen Information Service
Vitamin B12
CATEGORY:C
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Vitamin D
BREAST FEEDING: Compatible
NEONATAL SIDE EFFECTS:Hypercalcemia
CERCA LETTERATURA
Warfarin
CATEGORY:D
Anticoagulant
Embryopathy: Nasal hypoplasia, stippling of secondary epiphysis, IUGR, anomalies of eyes, hands, neck, and CNS.
Up to 25% risk of an affected infant following exposure until the 14th week of
pregnancy. Later exposure is associated with fetal hemorrhage, abruption,
and stillbirth [1].
BREAST FEEDING: Compatible With Breastfeeding[G3].
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
1.Teratology. ACOG technical bulletin number 236--April 1997
Zidovudine
CATEGORY:C
BREAST FEEDING: Breast feeding is contraindicated
in HIV infection
NEONATAL SIDE EFFECTS:
CERCA LETTERATURA
Zolpidem
Zolpidem (Ambien ®)
Hypnotic. Non-benzodiazepine of the imidazopyridine class, shares some of the
pharmacological properties of the benzodiazepines. Molecular weight:764.88
CATEGORY:
B
Reproductive studies conducted in rats and rabbits showed no teratogenic
effects after zolpidem administration. In rats and rabbits no fetal toxicity was
noted at 5 times and 7 times the maximum human dose (on a mg/m 2 basis)
respectively. [1]
In rats, adverse maternal and fetal effects occurred at 20 and 100 mg base/kg
and included dose-related maternal lethargy and ataxia and a dose-related trend
to incomplete ossification of fetal skull bones. In rabbits there was an
increase in postimplantation fetal loss and underossification of sternebrae in
viable fetuses at the dose of 16 mg base/kg. These fetal findings in rabbits are
often secondary to reductions in maternal weight gain [1].
Although animal studies have been reassuring data on the use of zolpidem
during human pregnancy is minimal. In one observational study from England first
trimester exposure in 18 pregnancies (including one set of twins) resulted in
delivery of 11 normal infants and two spontaneous abortions. Six women chose to
have elective abortions [2].
BREAST FEEDING: Excretion of zolpidem into human milk appeared to be
very low (less than 0.02% of the total administered dose) in a study of five
lactating women treated with a single 20 mg dose of zolpidem. The milk:plasma
ratio was 0.13 at 3 hours [3]. The American Academy of Pediatrics considers
zolpidem to be compatible with breastfeeding [4].
NEONATAL SIDE EFFECTS: Although withdrawal may occur with excessive doses
of zolpidem, the incidence of rebound insomnia or withdrawal symptoms after
discontinuation of the drug when it is given as recommended appears to be much
lower than that of benzodiazepines [5-7]. Nonetheless children born of mothers
taking sedative/hypnotic drugs may be at some risk for withdrawal symptoms from
the drug during the postnatal period. In addition, neonatal flaccidity has been
reported in infants born of mothers who received sedative/hypnotic drugs during
pregnancy. [1]
SEARCH
LITERATURE
1. Physicians
Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2004: 3008
2. Wilton LV, Pearce GL, Martin RM et al: The outcomes of pregnancy women
exposed to newly marketed drugs in general practice in England. Br J Obstet
Gynaecol 105:882-889, 1998. MEDLINE
3. Pons G, et al., Zolpidem excretion in breast milk. Eur J Clin Pharmacol.
1989;37:245-8. MEDLINE
4. Transfer
of drugs and other chemicals into human milk. Pediatrics. 2001;108:776-89.
5. Aragona M.Abuse, dependence, and epileptic seizures after zolpidem withdrawal:
review and case report.Clin Neuropharmacol. 2000;23:281-3. MEDLINE
6. Hajak G, et al., Abuse and dependence potential for the non-benzodiazepine
hypnotics zolpidem and zopiclone: a review of case reports and epidemiological
data.Addiction. 2003;98:1371-8 MEDLINE
7. Holm KJ and Goa KL.Zolpidem: an update of its pharmacology, therapeutic
efficacy and tolerability in the treatment of insomnia. Drugs. 2000;59:865-89. MEDLINE
GENERAL REFERENCES
G1.Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy
and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002
G2. Cunningham GF, MacDonald PC et al (eds);Williams Obstetrics,20th
ed,Stamford ,CT:.Appleton and Lange, 1997
G3. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Review.
G4 .Shepard TH. Catalog of Teratogenic Agents. 9th ed.Baltimore,
MD: Johns Hopkins University Press, 1998
G5. Gleicher Norbert ed. Principles & Practice of
Medical Therapy in Pregnancy. 3rd ed. Stamford, CT: Appleton & Lange,
1998
G6. Physicians' Desk Reference. 54th ed. Montvale, NJ: Medical Economics Company,2000
G7. Centers for Disease Control & Prevention. General Recommendations on Immunization:
Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 43 (No.
RR-1): 20-21, 1994.
G8. The WHO Working Group, Bennet PN (ed).: Drugs and Human
Lactation. Elsevier, Amsterdam, New York, Oxford, 1988.
G9.Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human breast milk. Pediatrics 93:137-150, 1994.
G10.Heinonen OP, Slone D, Shapiro S: Birth defects and drugs in pregnancy. Littleton:Publishing Sciences
Group, 1977
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