Topamax is an anticonvulsant drug used to treat epilepsy. It is also used to prevent migraines. Between 2007-2010, there were 32.3 million prescriptions for Topamax filled out. Now the U.S. Food and Drug Administration said that the drug can cause oral birth defects, such as cleft lip and cleft palate, in babies whose mothers take it during pregnancy.
Cleft lip and cleft palate occur when parts of the lip or palate fail to completely close together early in the first trimester of pregnancy.
Infants born with the defect may have difficulties feeding, and as they get older, difficulties with talking. They are also more likely to have ear infections. Babies with the defect are usually offered surgery to correct the issue.
“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said. “Alternative medications that have a lower risk of birth defects should be considered.”
Data from the North American Antiepileptic Drug (AED) Pregnancy Registry shows that 1.4 percent of babies whose mothers took Topamax during their pregnancy were born with cleft lip or cleft palate. This is a worse defect rate than for other epilepsy drugs which cause defects in about 0.38-0.55 percent of cases.
Based on this data, the Topamax will be changed from a category C drug to a category D drug, which means that there is positive evidence of human fetal risk.
The drug should not be used for pregnant women if their condition is not life threatening.
What Should Patients Do?
If you are epileptic, talk to your doctor about alternative treatments. Topamax is only one option. There are other epilepsy medications.
If you are pregnant, or intend to become pregnant, and you are taking Topamax, tell your doctor.
Topamax passes through breast milk and its effects on babies are unknown. Talk to your doctor about an alternative medication while breast feeding.
If you don’t want a baby and you would like to take Topamax, make sure you also have an effective method of contraception.
Sources:
http://www.fda.gov/Drugs/DrugSafety/ucm245085.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245594.htm