FDA responds to criticism; starts publishing quarterly Drug Safety Newsletter

WASHINGTON The Food and Drug Administration has issued a new report describing potential risks of several medicines including; the cancer drug Rituxan, the narcolepsy drug Provigil, the brain cancer medicine Temodar, and the blood infusion drug Exjade, after criticism of the agency being laidback in policing the drugs once they were on the market, according to Reuters.

The report, called the FDA’s Drug Safety Newsletter, is a response to an Institute of Medicine report criticizing the agency's failure to follow up on approved drugs once they were on the market.

The report describes cases of serious skin reactions linked to Cephalon's sleep disorder drug Provigil; fatal aplastic anemia seen with Schering Plough's Temodar; and a potentially fatal central nervous system disorder associated with Genentech's Rituxan.

The report will be published quarterly.

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