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Health

FDA panel reviews diabetes drug linked to dozens of deaths

graphic

March 25, 1999
Web posted at: 10:28 p.m. EST (0328 GMT)

From Correspondent Fred Katayama

WASHINGTON (CNN) -- A Food and Drug Administration advisory committee is meeting Friday to review the safety of Rezulin, a diabetes drug that critics blame for fatal liver problems in some patients.

While many diabetics see Rezulin as a wonder drug that has liberated them from insulin injections, the FDA has linked the drug to 28 deaths.

"This drug simply does not show benefits to outweigh its risks," says Thomas Moore, a health researcher at George Washington University. "As we focus on those risks, it tells us that this drug does not belong on the market today.

But Carol Goodrich, a spokesperson for Warner Lambert, which makes the drug, said the company is "confident (that) when all relevant data are reviewed in their entirety, the advisory committee will agree with us."

More than 1.5 million people have used the drug since it was introduced two years ago. Rezulin has become one of Warner Lambert's best-selling drugs, garnering $750 million in sales last year.

FDA officials wouldn't comment before Friday's meeting, but critics say the drug's problems are even worse than the government has reported.

They cite a February 3 letter from the FDA to U.S. Rep. Henry Waxman, D-California, saying 100 Rezulin patients died after experiencing "liver adverse events."

The FDA is expected to release its latest figures Friday. But some financial analysts who study the drug industry predict that FDA will not pull Rezulin from the market.

"If the FDA thought Rezulin risks outweighed its benefits and they wanted to pull it off the market, they wouldn't wait for this meeting. They would pull it off right away," said Sharon Doering, pharmaceuticals analyst for Madison Securities.


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Newly Approved Drug Therapies (200): Rezulin (troglitazone), Parke-Davis
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