The FDA says that Johnson & Johnson's Topamax, an epilepsy and migraine medication, creates an increased risk for babies born with cleft lip and palate injuries. In fact, it says that pregnant women who take Topamax or topiramate are about 20 times more likely to have their infants develop cleft lips or cleft palate deformities than those who are not treated.
Topamax Injuries / Topiramate Injuries
The U.S. Food & Drug Administration (FDA) issued a label change for Johnson & Johnson's (J&J) drug Topamax – which made the company over $2.5 billion in 2008 – and its generic counterpart, topiramate, manufactured by Teva Pharmaceutical Industries Ltd, Watson Pharmaceuticals Inc, Mylan Inc and several other generic drug makers.
Topiramate and Topamax, anticonvulsant medications approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures, are also approved for use to prevent migraine headaches.
The FDA warned Topamax and topiramate users, neurologists and OB/GYNs that there is a 20 percent increased risk of Topamax injuries and topiramate injuries such as the development of cleft lip and/or cleft palate (oral clefts) in newborns when used by women during pregnancy.
The increased risk is based upon information it received from the North American Antiepileptic Drug (NAAED) Pregnancy Registry – a hospital-based registry established to determine the safety of seizure medications that can be taken by women during pregnancy. The Administration says that the patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.
What Are Cleft Lips / Cleft Palates?
Cleft lips and cleft palates occur when a baby's mouth doesn't fully form, causing a "split lip" or a hole in the roof of the mouth. These conditions can be serious as it can make it nearly impossible for babies to get adequate nutrition. While the problem can often be corrected with surgery, it often takes several surgeries to complete.
What To Do If You've Taken Topamax / Topiramate
The FDA recommends that:
Of course, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional before starting Topamax or topiramate.
Topamax Lawsuits
No injuries have yet been reported and the FDA says that, despite its risks, Topamax may offer potential benefits from use of the drug in pregnant women may be acceptable in certain situations. However, personal injury lawyers whose practices focus on disfigurement and defective products say that Topamax lawsuits are likely now that the drug is in Pregnancy Category D – which means that there is positive evidence of human fetal risk based on human data.