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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: Edderd who wrote (17881)	1/18/1999 10:37:00 PM
From: AlienTech	Read Replies (1) \| Respond to of 23519

FDA Panel Will Review Safety Profile Of Warner-Lambert Drug for Diabetes By ROBERT LANGRETH and ROCHELLE SHARPE Staff Reporters of THE WALL STREET JOURNAL A Food and Drug Administration scientific advisory panel will meet to review the safety profile of Warner-Lambert Co.'s Rezulin for diabetes, amid growing concern over the potential of the drug to cause potentiall deadly liver damage. The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will debate what additional steps can be taken to make the diabetes drug safer in light of 32 deaths and four liver transplants linked to liver damage in patients taking versions of the drug. The big-selling drug already has been the subject of two warnings to doctors, including one urging that liver en zyme tests be conducted monthly in patients taking the drug. FDA officials said they are calling the March 26 hearing because two Rezulin users died from liver damage in November even though they had received liver-enzyme tests. The patients, a 91-year-old woman and a 63-year-old woman, were on the drug for just a few months, but within a few weeks of having normal enzymes, they developed liver toxicity and died, according to Murray Lumpkin, deputy director of the FDA's Center for Drug Evaluation and Research. In one case, the exact cause of liver damage was difficult to determine, he said, because the patient had other diseases and was on other medications.