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FDA warns on J&J's Topamax

The US FDA has warned that J&J's epilepsy drug Topamax increases the risk of the birth defects cleft lip and cleft palate if taken during pregnancy

The US Food and Drug Administration (FDA) has issued a warning that Johnson & Johnson's epilepsy drug Topamax (topiramate) and its generic versions increase the risk of the birth defects cleft lip and cleft palate if taken during pregnancy.

Topamax, which is also approved to prevent migraines, will now carry a stronger warning in its labelling and will be moved into the FDA's Pregnancy Category D, meaning that there is evidence of foetal risk based on human data but that the potential benefits in pregnant women may outweigh the risks in some situations. The drug was previously in Category C, reflecting a lack of human data.

"Healthcare professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age," said Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Alternative medications that have a lower risk of birth defects should be considered."

Healthcare professionals should warn patients of the risks associated with the drug and should inform women of childbearing age of the need to use effective birth control if they take topiramate, the FDA said. This can be complicated by the fact that topiramate can lessen the effectiveness of hormonal birth control, the agency noted.

The FDA based the new warning on data from the North American Antiepileptic Drug Pregnancy Registry, which showed that topiramate taken during pregnancy was linked to a 1.4 per cent prevalence of oral clefts, compared with a prevalence of between 0.38 per cent and 0.55 per cent with other antiepileptic drugs.

According to the FDA, about 32.3m topiramate prescriptions were dispensed and approximately 4.3m patients filled topiramate prescriptions from outpatient retail pharmacies in the US between January 2007 and December 2010.

7th March 2011

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