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May 21st, 2005

"FDA issues drug warnings on its Web site"

The U.S. Food and Drug Administration has started issuing alerts to patients and doctors on its new site Drug Watch. Including emerging drug-safety concerns, as well as dangers presented by drugs prescribed for unapproved uses, the new site is in response to growing criticism by Congress, safety groups and consumers for its slow response in issuing emerging information regarding drug dangers.

The acting director of the FDA’s Center for Drug Evaluation and Research, Dr. Steven Galson, believes the new addition is a “fundamental change”. In the past, the FDA spent months, and even years, discussing safety information with drug companies before the general public was made aware of concerns.

Because of the growing use of prescription drugs for off-label purposes, the FDA’s new site emphasizing risks posed by drugs never approved by the agency is an especially notable addition. There have been very significant off-label uses of drugs, and though the practice has proved extremely beneficial for some patients, in other uses there is little proof of effectiveness, even proven useless in studies.

Marking a significant change in the way the FDA is trying to provide more information about drug safety to the public, Drug Watch will allow more consumers to become better educated about their treatment options.