Topiramate Pregnancy and Breastfeeding Warnings
Topiramate Pregnancy Warnings
FDA pregnancy category: D Topiramate should be used during pregnancy only if the potential benefit outweighs the potential risk. Adequate methods of contraception should be encouraged.
Animal studies have revealed evidence of teratogenicity, embryotoxicity, and maternal toxicity. There are no controlled data in human pregnancy. Infants exposed to topiramate 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. 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/. 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
Data on 5 breastfeeding infants exposed to topiramate showed infant plasma topiramate levels equal to 10 to 20% of the maternal plasma level. Topiramate has been demonstrated to be excreted into the milk of lactating rats.
Potential benefit should outweigh the potential risk. Excreted into human milk: Yes Excreted into animal milk: Yes The effects in the nursing infant are unknown.
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