REZULIN: Warner-Lambert Seeks FDA Hearing
With controversy swirling over its diabetes drug Rezulin, Warner-Lambert, the drug's manufacturer, has asked the FDA to hold a public hearing to discuss the drug's safety, the Wall Street Journal reports. Warner-Lambert would like the FDA to hold a scientific advisory panel in July to discuss the risks and benefits of taking the medication. Rezulin has been linked with several deaths from liver failure. Although the FDA has added numerous warnings to the drug's label, the agency has allowed Rezulin to remain on the market. But the FDA is facing mounting pressure to recall the drug since two less-toxic diabetes medications have been approved. Agency officials are considering holding the hearing, but have yet to set a date (3/13).
Trouble at the Top
Despite reaffirming its confidence in Rezulin in a March 1 meeting, some top FDA officials have "expressed concern" that delaying a decision to recall the drug will put many more diabetes patients at risk, the Los Angeles Times reports. According to an internal FDA e-mail obtained by the Times, Dr. Saul Malozowski, team leader in the agency's endocrine drugs division, wrote, "My question is: How many fatal cases will suffice, to put to rest (Warner-Lambert's) argument? I believe that one case will be too many." He added, "The number of (liver) associated deaths with Rezulin ... is in excess of anything previously seen with any of the approved (diabetes) drugs. ... We know now what has happened with Rezulin and there is not a single piece of information to believe that either new or old patients will not develop severe or fatal complications with it." Four other veteran FDA officials are said to have raised similar concerns. However, Dr. Murray Lumpkin, deputy director of the FDA's Center for Drug Evaluation and Research, and his superior Dr. Janet Woodcock, continue to support Rezulin. Lumpkin has made it known that in order to recall the drug, the FDA must prove that the other two approved diabetes drugs, Avandia and Actos, are less toxic than Rezulin (Willman, 3/10).