Press Releases
| FDA Wants Epilepsy-Drug Warnings |
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In June, the agency said it was finalizing plans to include language warning about suicidal behavior on the drugs' labels after saying studies show statistically significant differences in suicidal tendencies for patients who have taken the drugs. It was unclear at the time whether the agency would seek black-box warnings. An updated label warning about suicidal behavior would likely affect Pfizer more than any other company. Its epilepsy drug, Lyrica, is relatively new to the market and brought in $1.8 billion in sales in 2007. Pfizer has disputed the FDA's data, saying its own information shows Lyrica isn't associated with a risk for suicidal behavior. Other drugs whose labels may be updated are Cephalon Inc.'s Gabitril and Novartis AG's Trileptal. Source: Wall Street Journal |



