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FDA to toughen warnings on migraine drug

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. Get the full story »

FDA asks Vivus to study diet drug, birth defects

Vivus Inc. said Friday the Food and Drug Administration has asked the drug developer to assess the feasibility of a study on whether an ingredient in the weight-loss drug Qnexa causes birth defects.

The request represents another setback for the drug intended to treat obesity. Vivus and rival Arena Pharmaceuticals Inc. had their diet drugs rejected by the agency in October, as competitor Orexigen Therapeutics Inc.’s weight-loss drug Contrave continued to move through the approval process. Get the full story »

Weight-loss drug show strong results as FDA set to rule

An experimental weight-loss drug made by Vivus Inc. helped obese people lose more than 10 percent of their weight after two years in a clinical trial, but safety details were scant for the drug, which in July was turned down by a panel of U.S. experts.

The company said Tuesday that the second year of a clinical trial found that patients taking the highest dose of its drug, Qnexa, lost an average of 26 pounds, or 11.4 percent of their body weight. Patients taking a placebo had weight loss of 2.5 percent. Get the full story »