Drug regulator probes CellCept, Myofortic safety

04/11/2008 | United Press International

The FDA said it is evaluating the safety of two organ transplant rejection treatments -- Hoffmann-La Roche's CellCept and Novartis AG's Myofortic -- after learning of their association with progressive multifocal leukoencephalopathy. Roche, which has forwarded a review of safety data to the agency, proposed listing PML as a rare complication on its product's label, while Novartis has been asked to submit similar documents. The agency encouraged health care professionals and consumers to report complaints or problems with the drugs, but did not advise against their use.

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