FDA probes Roche, Novartis meds

The transplant drug probe is widening. FDA says it's identified 16 cases of an often-fatal neurological disease among patients taking Roche's CellCept drug, used to prevent organ rejection. The agency will review the reports and work on new labeling for the med over the next couple of months; in the meantime, FDA is warning doctors and patients to look out for neurological symptoms. The agency also is looking at similar risks with Myfortic, a drug made by Novartis that has the same active ingredient, though it hasn't received any reports of the disease in those patients.

You'll recall that Roche alerted FDA to the issue in November after receiving reports of progressive multifocal leukoencephalopathy, which attacks the brain and central nervous system; the disease is usually fatal, and survivors are often permanently disabled. Roche independently confirmed 10 cases of the disease in CellCept patients. Some 500,000 patients worldwide have used the drug, however. European regulators have already added cautionary language to the drug's label; Roche has submitted new labeling to the FDA, but the agency is still reviewing it.

- see the communication [1] from the FDA
- read the Washington Post article [2]

ALSO: Genzyme is recalling more than 100,000 vials of Thymoglobulin, a kidney transplant drug, because of a manufacturing problem; no safety or efficacy problems have been found, however. Report [3]

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Aspreva's CellCept fails late-stage superiority study. Aspreva report [6]