Topiramate Pregnancy and Breastfeeding Warnings

Topiramate is also known as: Qudexy XR, Topamax, Topamax Sprinkle, Topiragen, Trokendi XR

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.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web1)