Migraine Preventive Topamax May Cause Birth Defects

The study was supported by a research grant from the Epilepsy Research Foundation and by unrestricted educational grants from GlaxoSmithKline, sanofi-aventis, UCB Inc., Janssen-Cilag, Pfizer, and Eisai.

Summary and comments:

Charting some of the the data from the study helps show the outcome more clearly:

The conclusion of the study as stated in the study abstract is concise and to the point:

"The number of outcomes of human pregnancies exposed to topiramate is low, but the major congenital malformation rate for topiramate polytherapy (topiramate with other medications) raises some concerns. Overall, the rate of oral clefts observed was 11 times the background rate. Although the present data provide new information, they should be interpreted with caution due to the sample size and wide confidence intervals."¹

Decisions about taking medications when pregnant or when you may become pregnant are difficult at best. It's important to you and your baby to control Migraine disease and other health issues, but it's also important to you to protect your unborn child. Here are my suggestions:

• If you're pregnant and taking or considering taking topiramate, talk with your doctors as soon as possible. Be sure that, if you're seeing more than one doctor, they consult with each other about your pregnancy and your medications.
• If you are not pregnant but might become pregnant: Discuss these issues carefully with your doctors and weigh the risks of any medications against their benefits.
• If you are not pregnant, don't want to become pregnant, and taking or considering taking Topamax, carefully investigate the impact of topiramate on oral contraceptives. You may need to use other forms of contraception in addition to oral contraceptives.