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News - Serzone Under Fire

Posted by jrbecker on March 16, 2003, at 18:50:33

Serzone Under Fire (March 15, 2003)

Public Citizen, the public interest lobby founded by Ralph Nader, has petitioned the FDA to immediately remove Serzone from the US market. The petition cites “28 reports of liver failure leading to necrosis or death,” involving 18 deaths worldwide. According to Public Citizen, in January this year the drug’s manufacturer, Bristol-Myers Squibb. withdrew Serzone from Sweden when regulators there demanded a liver enzyme monitoring requirement be added to the product's labeling, and very soon after from the rest of Europe when other countries were considering the same requirement. Public Citizen also pointed out that Serzone is metabolized by the enzyme CYP3A4, which results in raised toxicity for other drugs administered simultaneously, including a 50-fold increase for Buspar. Other drugs affected include Xanax, Halcion, desipramine, Tegretol, Prozac, and the MAOIs.

The drug's labeling contains a black box warning added in Jan 2002, stating that one side effect is potential fatal liver failure. Bristol-Myers says it pulled out of Europe because of low sales rather than safety issues.




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