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Biotech / Medical : wla(warner lambert) -- Ignore unavailable to you. Want to Upgrade?

To: margie who wrote (635)	3/26/1999 5:32:00 PM
From: John Carragher	Respond to of 942

thanks for the explanation. John

To: margie who wrote (635)	3/26/1999 7:30:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 942

6:17 PM Dow Jones article: WASHINGTON (Dow Jones)--Based on its current labeling, a federal panel said when used alone to treat diabetes, Warner-Lambert Co.'s (WLA) Rezulin seems to do more harm than good. However, when Rezulin is coupled with insulin or sulfonylurea, its benefits outweigh the risks, the panel said. Some panel members suggested Rezulin's label be modified to increase monitoring. In a press release after the meeting, Warner-Lambert said that the advisory committee reaffirmed Rezulin's "benefit for most type 2 diabetes patients." "Warner-Lambert will continue to work with the FDA to further refine the label," said Dr. Robert Zerbe, a Warner-Lambert senior vice president. The U.S. Food and Drug Administration called together one of its outside scientific panels to review cases of liver problems that led to death or liver transplants among patients taking Rezulin. The panel also discussed Warner-Lambert's bid to have Rezulin's approval extended so it can be marketed as part of triple therapy in combination with sulfonylurea and metformin. The panel didn't have an official vote on triple therapy, but most panelists agreed triple therapy would be helpful for patients who have failed other treatments. The FDA will make the final decision on the future of Rezulin, which it says is responsible for 28 liver-related deaths and seven liver transplants. The agency usually follows the advice of the expert panels it convenes. Colleen A. Colley, a panel member and pharmacist at the Veteran's Affairs Medical Center in Portland, Ore., said patient education is crucial. "Before a patient takes this drug they need to be aware of the dangers," Colley said. Panelist Dr. Leonard B. Seeff, senior scientist for hepatology research at the National Institute for Diabetes at the National Institutes of Health, agreed patient education is a must. "We need to educate the patient and give them an option," Seeff said. "We need to let patients know we are offering them a drug that could potentially cause their death." The panel also said doctors need to make sure Rezulin patients are strictly monitored for abnormal liver enzyme levels. Some panelists also suggested an increase in liver monitoring. Currently, Rezulin's label calls for liver enzyme monitoring monthly for the first eight months a patient is on the drug, every other month for the remainder of the first year and periodically after that. The FDA approved Rezulin in January 1997. Last year, the drug recorded $748 million in sales. - Otesa Middleton; 202-862-6654 (END) DOW JONES NEWS 03-26-99 06:17 PM