Inside these posts: Birth defects

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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 »

Ex-workers sue Motorola over kids’ birth defects

Motorola Inc. is facing a lawsuit from a group of former employees alleging that exposure to hazardous chemicals caused birth defects in their children.

The suit, filed last week in Cook County Circuit Court, names 71 plaintiffs. The filing also lists more than 30 children who, according to the suit, suffered injuries as a result of their parents’ exposure to hazardous substances used to make semiconductors. Get the full story »