FDA Warns That Epilepsy Drug Carries 2000% Increased Risk Of Oral Birth Defects

Based on information that was collected from the North American Antiepileptic Drug Pregnancy Registry, the United States FDA has issued a warning for the prescription drug Topamax, and its generic counterparts sold under the chemical name topiramate. The warning is specifically targeted to pregnant women, and even more specifically, those in the first 3 months of pregnancy. The drug with is primarily prescribed for epilepsy can sometimes also be prescribed for migraine headaches. Information from the registry shows that if this drug is taken during pregnancy, especially while in the early months when expectant mothers may not exactly be expecting to be pregnant, there is a 2000% increased chance of their child having oral birth defects like cleft lip or cleft palate.


The name brand Topamax, manufactured by Johnson & Johnson was responsible for more than $2..5 billion dollars in sales a year before generics started showing up in 2009, though it still accounted for nearly $570 million in 2010. J&J was quick to defend their product and state that it already has plenty of information and warnings regarding cautious use during pregnancy. However, they also stated that they will work with the FDA to make sure that recommendations for use among pregnant women are further clarified.


Cleft lips or palates occur naturally in roughly 0.07% of infants. When data from mothers who had been on Topamax and similar generics was analyzed, the numbers skyrocketed to 1.4%. Even women who were on different epilepsy drugs other than Topamax had an increase to around 0.38%. However, the difference between that level and topiramate derivatives is staggering. Its also worth mentioning that J&J was previously involved in a lawsuit regarding Topamax in which they were accused of illegal marketing and hiring doctors to work with their drug reps to encourage more doctors to prescribe it for uses that it wasnt approved for- like migraines.




Bloomberg Businessweek


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