Rezulin Recall

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 concerns when seeking federal approval by assuring the diabetes drug had low risk. 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.

Although the company claimed the studies of Rezulin were comparable to placebos, in reality 2.2% of the patients taking Rezulin had suffered liver problems versus just 0.6% of the placebo patients. During depositions, Warner-Lambert was questioned about their previous statements claiming Rezulin and placebo studies were similar, and the vice president for diabetes research stated he did not "think that these numbers are all that different." Dr. John Gueriguian, an FDA medical officer that was assigned to examine Rezulin, told the company as early as 1994 of his concern about the potential toxicities, but his boss, Dr. Alexander Fleming, reportedly told a Warner-Lambert executive in 1995 in a memorandum that he would "ease Dr. Gueriguian out".

In 1996, Dr. Gueriguian was removed from the Rezulin case, and although Dr. Fleming emailed a copy of his report to Warner-Lambert, the information was withheld from the advisory committee that had examined the drug. Two days before that 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."

The FDA has been under public scrutiny because of conduct issues. In a letter to the Department of Health and Human Services the Public Citizen group urged HHS leaders and all government agencies to re-read and strongly urge the implementation and enforcement of a 1958 Congressional Resolution entitled The Code of Ethics for Government Service that states "Any person in Government Service should put loyalty to the highest moral principles and to country above loyalty to persons, party or Government department." in addition to the section stating that government "employees shall disclose waste, fraud, abuse, and corruption to appropriate authorities."

Rezulin was approved under conditions that many FDA physicians describe as lowered safety standards. During the course Rezulin was on the U.S. market the FDA strengthened the Rezulin labeling four times due to the continuation of liver failure deaths and injuries Rezulin was associated to, the first one occurring in November of 1997 until the Rezulin recall in 2000.

If you have taken Rezulin and would like more information regarding the Rezulin recall, contact us to speak with a Rezulin Recall attorney. You may be entitled to a large compensation for the damages and suffering that have resulted from taking the diabetes drug.

To view the Public Citizen letter click here.

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