Rezulin was approved in January 1997, 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 Rezulin liver failure deaths and Rezulin liver damage, the first one occurring in November of 1997 up until the Rezulin recall in 2000. Prosecutors that were assigned to the office of the U.S. attorney questioned FDA officials in July 2000. They explored the Warner-Lambert’s conduct, as well as the FDA’s conduct.

The Los Angeles Times reported that Warner-Lambert downplayed Rezulin 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 Rezulin liver damage that was potentially life threatening as early as 1993.

By the time of the Rezulin recall on March 21, 2000, there were 90 cases of Rezulin liver failure, including 63 deaths, 7 liver transplant survivors, 10 recoveries without a liver transplant, and 10 people continuing to suffer from liver failure.

Patients taking Rezulin are 1,200 times more likely to suffer liver failure and Rezulin liver damage according to Dr. David J. Graham, the FDA’s top expert in assessing and preventing deaths related to the use of prescription drugs.

Warner-Lambert knew of the dangerous Rezulin side effects, including Rezulin liver damage, far before the FDA ordered the diabetes drug to be withdrawn. If you have suffered from Rezulin liver damage or other side effects because of the negligent practices that Warner-Lambert used to manufacture and market Rezulin, CONTACT US.