FDA to toughen warnings on migraine drug

By Dow Jones Newswires
Posted March 4 at 11:51 a.m.

The U.S. Food and Drug Administration said it will strengthen warnings on the anti-migraine and anti-seizure treatment Topamax and its generic equivalents after new data suggested a higher risk for cleft palates in babies born to women taking the drug.

The move represents a setback for health-care products giant Johnson & Johnson, which owns Topamax maker Ortho-McNeil Pharmaceutical LLC. The subsidiary last May pleaded guilty to promoting the drug for off-label uses and had to pay an $81.5 million fine.

The warning could also affect Vivus Inc., which is trying to get its weight-loss drug Qnexa to the market after the FDA asked for more information about its potential to cause birth defects. Qnexa is a combination of topiramate, the main ingredient in Topomax,  and the stimulant phentermine, which  reduce appetite and make the user feel more satisfied.

Shares of Vivus fell 7.8 percent, to $6.50, Friday, while Johnson & Johnson shares were off 0.9 percent, to $60.52, amid a broad market decline.

The FDA said Friday that data from the North American Antiepileptic Drug Pregnancy Registry indicated an higher risk of oral clefts in infants exposed to topiramate in the first trimester of pregnancy. Infants exposed to topiramate as a single therapy had a 1.4 percent prevalence of oral clefts, compared with a 0.38 percent to 0.55 percent prevalence in those exposed to other antiepileptic drugs.

The regulator said health care professionals should warn patients of childbearing age about the drug ingredient’s hazard and said it will strengthen the warning on the drug’s labeling.

The new labeling will mean there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women could sometimes outweigh the risks.

In a statement, Johnson & Johnson said it is working with the FDA to update the Topamax label and noted that the current prescription information already recommends cautious use in pregnant patients.

Topamax is used as an epilepsy treatment and as a preventative drug to prevent migraines before they start.

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