On March 4, 2011, the FDA issued a safety alert regarding birth defects and the medication Topamax and its generic form, topiramate. Topamax is prescribed for epileptics as an anticonvulsant medication that can help with certain types of seizures. The medication can also be prescribed for prevention of migraine headaches.

The FDA alert was issued as a result of new data reported to the FDA which shows a significant increase in the development of a cleft palate and/or cleft lip in babies whose mothers were taking the medication while pregnant.

Cleft is a term which means failure to join. When babies are developing in the womb, the roof of the mouth or palate is initially separated, left and right. With normal development at approximately 5–9 weeks into the pregnancy, these two sections fuse together in the fetus forming the solid, one-piece roof of the mouth. With a cleft palate defect these two sections never fuse, leaving a gap in the roof of the mouth that goes up into the nasal cavities. With a cleft lip, sections of the lip fail to fuse.

Babies can have difficulty eating with these birth defects. With the mouth completely open to the nasal cavities it is hard for these babies to have the ability to suck. Therefore special feeding procedures may be required to allow them to get enough nourishment. The children affected can also have issues with breathing, hearing, speech, and language. Surgical repair of these defects is recommended within a baby’s first 18 months. Many children need to have additional surgeries as they grow older.

The FDA alert regarding Topamax and it’s generic, topiramate, is based upon data supplied to the FDA by the North American Antiepileptic Drug (NAAED) Pregnancy Registry. We have attached the link to the FDA Safety Communication below, which discusses the actual data submitted to the FDA that led to their safety alert.

The use of Topamax and it’s generic, topiramate, is widespread. According to the FDA approximately 32.3 million prescriptions were dispensed for these medications between January 2007 and December 2010.

For more information regarding cleft palates and cleft lips, click here.

To read the FDA Safety Alert, click here.