REZULIN: FDA Panel Wasn’t Told Of Side Effects
Food and Drug Administration advisory panel members who urged approval of the diabetes drug Rezulin say they were not informed of potentially fatal liver complications, the Los Angeles Times reports. Three of the panel's eight members said that while they still would have ultimately recommended approval of the drug, they would also have cautioned doctors to monitor liver function carefully -- a warning the FDA did not issue until eight months after Rezulin hit the market. Both James Bilstad, the top FDA official on the Rezulin case, and Randall Whitcomb, an executive for Rezulin manufacturer Warner-Lambert, confirm that before the agency issued final approval, the drugmaker informed "at least four FDA officials, including Bilstad" about 11 patients who had suffered life-threatening liver toxicity complications. When asked why the information was not passed on to the panel, Bilstad said, "I can't answer that question." Panel member Dr. Jose Cara said, "If we had seen that sort of data, I think we would have been more cautious in terms of giving the drug such a strong voice of approval." In addition, the Timesreports, panel members were not informed that Dr. John Gueriguian, the veteran FDA medical reviewer assigned to evaluate Rezulin, opposed the drug's approval or that he had been removed from the case. Rezulin has been prescribed to more than 1 million patients and both the FDA and Warner-Lambert insist the drug is safe when liver function is monitored carefully, despite FDA reports that at least 33 deaths from liver failure have been linked to Rezulin (Willman, 12/18).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.