Topamax and it’s generic, topiramate, are anti-convulsant medications that can help prevent or minimize certain types of seizures, as well as migraine headaches. According to the FDA, approximately 32.3 million prescriptions were dispensed for these drugs between January 2007 and December 2010.
On March 4, 2011, the FDA issued a safety alert based on data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry showing a significantly increased risk for development of a cleft palate and/or cleft lip in babies whose mothers took Topamax or topiramate while pregnant.
A cleft palate and/or a cleft lip can result in the baby having difficulty sucking and eating. Special feeding procedures may be required in order ensure that the baby gets enough nourishment. Affected children can also have ongoing issues with breathing, hearing, speech, and language.
Surgical repair of these defects is recommended within a baby’s first 18 months, and 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 which lead to their safety alert.
If you or someone you care about has been affected by Topamax or topiramate, contact Siegfried & Jensen for a free, no obligation consultation.
The FDA Safety Communication regarding Topamax/topiramate is available online.