FDA details new drug risks after criticism

By Kim Dixon

WASHINGTON (Reuters) - The U.S. Food and Drug Administration issued a new report on Tuesday describing potential risks of several medicines after criticism that it was lax in policing drugs once they were on the market.

The FDA's Drug Safety Newsletter, aimed at healthcare professionals, details side effects associated with the cancer drug Rituxan, narcolepsy drug Provigil, brain cancer medicine Temodar, and blood infusion drug Exjade.

The report fills a commitment made by the FDA after the influential Institute of Medicine (IOM), an independent government body, issued a report in 2006 sharply criticizing the agency.

IOM concluded the FDA has a "dysfunctional" structure hindering its ability to protect public health.

The "early safety findings" section of the FDA's newsletter reports on potential risks from Novartis AG's Exjade, which treats iron overload from blood transfusions.

The FDA in May reported cases of kidney failure and deaths in patients taking the drug, known generically as deferasirox, although the agency called the relationship between the drug and the side effects "uncertain."

The newsletter cited 115 reports that include deaths and hospitalizations that it describes as "suspected" side effects linked to the drug. It says the deaths were reported as due to the underlying disease.

A spokeswoman for Novartis was not available for comment.

The report also 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 Biogen Idec and Genentech's Rituxan.

Schering-Plough spokeswoman Katherine Cantone said Temodar's label notes aplastic anemia as a potentially rare occurrence in the extremely ill brain cancer patients using the drug.

Officials at Cephalon and Biogen were not available to comment on the report.

Peter Lurie, a health researcher and doctor at the consumer group Public Citizen, which has been highly critical of the FDA, said that if the newsletter focuses on emerging side effects it has the potential to be "a real service."

The newsletter will be published quarterly.