The U.S. Food and Drug Administration (FDA) recently warned patients and healthcare providers of an increase in the risk of birth defects from taking the drug Topamax®. According to the FDA alert, cleft lip and cleft palate are more likely to occur in babies born to women who took the drug during pregnancy.
The FDA issued its warning March 4, 2011.
Topamax® is an anti-epileptic medication. It also is prescribed to prevent migraines, although it will not relieve the pain once the migraine has begun. The drug is also used for non-FDA approved off-label reasons.
In the alert, the FDA cautioned doctors to counsel their pregnant patients about using Topamax® during pregnancy and carefully weigh the benefits and risks of taking the drug. During the first three months of pregnancy the fetus’ lips and palate are forming. Any toxic substance interfering with this process, such as Topamax®, can cause facial deformities in the newborn.
During the first three months of pregnancy, a woman may not even know she is pregnant. So any woman of child-bearing age taking Topamax® should be especially aware of its potential harm, says the agency. Alternate medications should be considered, especially if using Topamax® is not essential to a patient’s health.
When making its announcement, the FDA also changed the drug’s pregnancy rating from pregnancy Category C to Category D. Category C suggests, from the collection of animal data, that a drug is teratogenic (causes birth defects), but there are no human studies to prove this point.
If named a Category D drug, it has been shown in human studies to cause birth defects. However, if the patient’s situation warrants using a drug that belongs to pregnancy Category D, it should be used with appropriate caution.
From January 2007 through December 2010, approximately 32.3 million topiramate prescriptions were dispensed and approximately 4.3 million patients filled topiramate prescriptions from the outpatient retail pharmacies in the U.S, according to information on the FDA website.
