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Monday, March 12, 2001
Diabetes drug risks known by manufacturer, report says
Documents reveal Warner-Lambert Co. downplayed liver damage concerns while seeking FDA approval for Rezulin
Associated Press
LOS ANGELES - Warner-Lambert Co. downplayed liver damage concerns as it sought federal approval for its diabetes drug Rezulin, the Los Angeles Times reported Sunday.
Warner-Lambert assured the U.S. Food and Drug Administration that the drug's risk was low, while FDA officials gave the company inside information and favors at key points in the drug's development, the newspaper reported, citing previously unpublicized company and government documents.
The company knew at least 12 people had suffered potentially life-threatening liver damage during clinical trials.
In December 1996, Warner-Lambert's vice president for diabetes research, Dr. Randall W. Whitcomb, told the Endocrine and Metabolic Drugs Advisory Committee of the FDA that incidences of damage were "comparable to placebo" in the studies, the Times said.
In fact, 2.2 percent of the patients who took the drug had suffered liver problems, compared to 0.6 percent who took the ineffective placebo pills.
The FDA approved the drug in January 1997. It garnered $2.1 billion in sales before it was withdrawn last spring after being suspected of causing 391 deaths, including dozens involving liver damage.
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a Scripps Howard newspaper. All rights reserved.
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