FDA probes Roche, Novartis Medicines

[Dr.Vikram]

FDA probes Roche, Novartis Medicines:
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.

Dr.Vikram.K
Source: Fierce Bioresearcher

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