REZULIN: Controversial Diabetes Drug Taken Off Market

      The FDA yesterday ordered that Warner-Lambert's diabetes drug Rezulin be immediately removed from the market, citing potentially fatal liver toxicity, the New York Times reports. Nearly 500,000 Americans currently take the drug to control Type-2 diabetes, but FDA officials cautioned patients to consult their physicians before halting treatments. Since its approval in 1997, Rezulin has been linked to 90 cases of liver failure, resulting in 63 deaths and 10 liver transplants, according to FDA officials (Grady, 3/22). Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, said, "The message today is not that there is an emergency, that people should stop taking the drug immediately. Patients have known for a long time that Rezulin can cause liver toxicity in some people -- they get a sheet about that every time they go to the drugstore." She added, "We are asking them now to talk to their doctors about using a different medication" (Kaufman, Washington Post, 3/22). The FDA resisted removing Rezulin because it has helped many of the more than 1.9 million people who have taken the medication. However, Woodcock said the agency reversed its position on Rezulin after last year's approval of Eli Lilly's Actos and SmithKline Beecham's Avandia, two new diabetes drugs that have less toxic side effects. "We're confident that they don't pose the kind of liver toxicity that Rezulin does," Woodcock said. President of Research and Development at Warner-Lambert/Parke-Davis Dr. Peter Corr said the company was surprised by the FDA's announcement. "We still believe that the benefits outweigh the risks and that this drug produces enormous benefits for patients." He said that the company would write letters to physicians telling them that Rezulin had been removed from the market (New York Times, 3/22). In a statement, the drug manufacturer said, "Patients taking Rezulin should consult with their physicians as soon as possible to discuss alternative therapies. Warner-Lambert will work closely with the FDA ... to assure a safe and efficient transition for patients" (Willman, Los Angeles Times, 3/22).

Too Little, Too Late?
      The move still does not address the allegations by the Public Citizen's Health Research Group that Warner-Lambert knew of the liver toxicities but failed to send side effect reports to the FDA until Rezulin was approved. While the FDA said it is still reviewing the charges, Warner-Lambert has denied the allegations (New York Times, 3/22). However, the FDA's British equivalent, the Medicines Control Agency, forced the drug's removal in late 1997 and refused to reinstate Rezulin last year citing safety concerns (Los Angeles Times, 3/22). Dr. Sidney Wolfe, director of Public Citizen, maintained that Rezulin "should have been gone a long time ago." He said, "The British government took it off the market a long time ago. The question is why did it take the FDA so long to take it off the market?" ( AP/Houston Chronicle, 3/22).