Topiramate Pregnancy and Breast Feeding Warnings
Topiramate is also known as: Topamax, Topamax Sprinkle
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Topiramate Sprinkle Capsules while you are pregnant. Topiramate Sprinkle Capsules is found in breast milk. If you are or will be breast-feeding while you use Topiramate Sprinkle Capsules, check with your doctor. Discuss any possible risks to your baby.
Topiramate Pregnancy Warnings
Topiramate has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity, embryotoxicity, and maternal toxicity. There are no controlled data in human pregnancy. Topiramate should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
In rats, an increased frequency of limb malformations, embryotoxicity and maternal toxicity was observed at doses ranging from 0.5 to 10 times the recommended human dose on a mg/m2 basis. Mice studies have also demonstrated fetal malformations (primarily craniofacial defects) when topiramate was administered during the period of organogenesis. The lowest dose which resulted in mice fetal malformations was 20% of the recommended human dose. Rabbit studies have also demonstrated embryo/fetal mortality. Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.
Topiramate Lactation Warnings
There are no data on the excretion of topiramate into human milk.
Topiramate has been demonstrated to be excreted into the milk of lactating rats.
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