Drug Safety

FDA Mulls Diabetes Drug Disclosure

Published in Medical Letter on the CDC and FDA, March 27th, 2000

The U.S. Food and Drug Administration is studying a request that it investigate a major drug manufacturer for delaying submission of information that a diabetes drug could cause liver problems in some patients.

The public interest group Public Citizen called for the probe into Warner-Lambert/Parke-Davis, charging the company knew of instances of liver problems associated with the drug Rezulin before it went on the market, but delayed informing the FDA.

An FDA spokesman, speaking on condition of anonymity to the Associated Press, said the agency is reviewing the request for an investigation and will take whatever action is appropriate.

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Source: Medical Letter on the CDC and FDA (2000-03-27)

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