To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Panel Says Rezulin Should Stay On Market URL: http://www.pslgroup.com/dg/F066A.htm Doctor's Guide March 29, 1999
BETHESDA, MD -- March 29, 1999 -- The controversial diabetes drug Rezulin (troglitazone) should stay on the market, experts told the United States Food and Drug Administration on Friday after analyzing the most recent data on the drug's benefits and side effects, including reports of liver failure seen in 28 patients taking the drug, according to an article by Reuters Health . The drug, made by Warner-Lambert's Parke-Davis division, has caused at least 40 cases of severe liver disease -- some so bad the patients had to have liver transplants, says Reuters. According to Reuters, the FDA's endocrinologic and metabolic drugs advisory committee said the drug, used for the treatment of type II diabetes, should remain available for use with the older diabetes therapies, insulin and the sulfonylurea. However, they said the drug might be too risky to make it worth taking by itself. About 15 percent of patients taking Rezulin now use it alone, but the committee recommended withdrawing that approval. Rezulin, the first of a new class of drugs that help the body respond better to insulin, is currently indicated for the treatment of type II diabetes. About 1.4 million people have taken the drug since it hit the market two years ago. According to the American Diabetes Association, nine out of 10 cases of diabetes, or 15 million Americans, have type II diabetes. The conditions is sometimes referred to as non-insulin-dependent diabetes or adult onset diabetes. The FDA panel spent Friday hearing evidence presented by the FDA and Warner-Lambert. The FDA usually follows the advice of its expert committees, but one consumer group has been calling for the drug to be taken off the market, according to the Reuters article. Reuters reported that David Graham of the FDA's office of post-marketing drug risk assessment said at least 40 cases of acute liver failure had been caused by Rezulin. Of these, 28 people died. But he said doctors do not report all cases of drug reactions. He estimated the risk of liver injury for a patient taking Rezulin for six months was about one in 1,800. "The longer you stay on Rezulin, the higher the risk you accumulate," Reuters reports Graham telling the panel. Parke-Davis estimates the risk is closer to one in 45,000 patients. The company told Reuters that the number of liver-related deaths had decreased since last year, when the company warned doctors and other health care workers that the drug could damage the liver. Patients must now take regular liver enzyme tests. Some members said perhaps Rezulin could be used alone if the labelling on the drug were changed to recommend more frequent monitoring, but they were not convinced it was helpful enough when used alone to make it worth the risk. Related Links: Rezulin, Warner-Lambert --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.