Topiramate Pregnancy and Breastfeeding Warnings
Topiramate Pregnancy Warnings
(UK): -When used for migraine prophylaxis: Contraindicated -When used for seizures: Use only if clearly needed and benefit outweighs potential risk. (AU, US): -Use only if clearly needed and benefit outweighs potential risk. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -It is recommended that women of child bearing potential use adequate contraception and consider alternative therapeutic options. -This drug should only be prescribed after the patient has been fully informed of the known risks of uncontrolled epilepsy during pregnancy and the potential risks of the drug to the fetus. -This drug should not be used by women of childbearing potential not using an effective method of contraception. -Infants exposed to this drug in the first trimester have an increased risk of congenital malformations (e.g., craniofacial defects, such as cleft lip/palate, hypospadias, and anomalies involving various body systems).
-Animal studies have revealed evidence of teratogenicity, embryotoxicity, and maternal toxicity. There are no controlled data in human pregnancy. -Infants exposed to this drug in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring. -This drug can cause metabolic acidosis. The effect of topiramate-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the ability of the fetus to tolerate labor. The North American Antiepileptic Drug (NAAED) Pregnancy Registry is collecting information about the safety of antiepileptic drugs during pregnancy. All patients should be encouraged to enroll if they become pregnant. Patients can call the toll free number at 1-888-233-2334 or go to http://www.massgeneral.org/aed/. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Topiramate Breastfeeding Warnings
Breastfeeding infants exposed to this drug showed infant plasma topiramate levels equal to 10% to 20% of the maternal plasma level.
(AU, UK): A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (US): Potential benefit should outweigh the potential risk. Excreted into human milk: Yes Comments: -If this drug is used during breastfeeding, the infant should be monitored for diarrhea, drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsant or psychotropic drugs.
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