Rezulin Recall Information

On March 21, 2000, the FDA announced the Rezulin recall after a whistleblower showed internal FDA email messages to an L.A. Times reporter. The diabetes drug was manufactured by Warner-Lambert to treat type-2 diabetes, which led to at least 90 cases of Rezulin liver failures, including 63 deaths. While this number is alarming, it reflects just 1-10% of actual fatalities according to experts. After speeding through the FDA approval process in just six months on the “fast track”, Rezulin had remained on the U.S. market for over three years after an estimated 2 million people were prescribed the controversial drug. Most pharmaceutical drugs take years to obtain FDA approval.

The Los Angeles Times reported that Warner-Lambert downplayed liver damage complication when seeking federal approval by assuring the diabetes drug risk was low. The FDA official gave the company inside information and favors at certain key points in the development of Rezulin according to the LA Times, citing previously unpublicized company and government documents. Warner-Lambert knew of at least 12 people that suffered from liver damage that was potentially life threatening as early as 1993.

In December 1996, the VP for diabetes research at Warner-Lambert, Dr. Randall W. Whitcomb, told the Endocrine and Metabolic Drugs Advisory Committee of the FDA that the studies of Rezulin were comparable to placebo. Despite this claims, 2.2% of the patients taking Rezulin had suffered liver problems opposed to a mere 0.6% of the placebo patients. After being questioned in a deposition, Whitcomb claimed he did not “think that these numbers are, are all that different.” The FDA medical officer that was assigned to examine Rezulin, Dr. John Gueriguian, informed Warner-Lambert as early as 1994 of his concern about the potential toxicities. Gueriguian’s boss, Dr. Alexander Fleming, reportedly told a Warner-Lambert executive in 1995 in a memorandum that he would “ease Dr. Gueriguian out”.

Dr. Gueriguian was removed from the Rezulin case in 1996. Dr. Fleming emailed a copy of his report to Warner-Lambert, but the information was withheld from the advisory committee that had examined the drug. Two days prior to the advisory committee meeting had taken place, Fleming had emailed the Warner-Lambert executive that “the drug looks like it ought to be on the market. Loosen up and put on a good presentation. Call if you need help.”

Warner-Lambert knew of the dangerous Rezulin side effects far before the FDA ordered the diabetes drug to be withdrawn.

If you have suffered because of the negligent practices that Warner-Lambert used to manufacture and market Rezulin, CONTACT US concerning the Rezulin Recall.