| Warner Lambert's diabetes drug Rezulin was withdrawn from the market on March 21, 2000 for safety reasons. Citizen advocate groups had petitioned the United States Food and Drug Administration as early as July 1998.
The withdrawal was the culmination of Warner Lambert's failed efforts to keep Rezulin on the market even after receiving reports of death and liver injuries among Rezulin users.
After receiving at least 35 reports of liver injuries in Rezulin patients, Warner Lambert announced a label change on November 3, 1997. Rezulin was banned in Great Britain on December 1, 1997.
By March 1999, the FDA estimated that more than 400 Rezulin patients had suffered liver damage.
On March 21, 2000, the FDA requested that Warner-Lambert withdraw Rezulin from the market. The FDA noted that Rezulin was more toxic than the two alternatives to Rezulin, Avandia and Actos. In the wake of the withdrawal, previously concealed adverse information regarding Rezulin has emerged.
Dr. Neal Kaplowitz, a liver specialist and former Warner-Lambert consultant said: "I think as I look back at it retrospectively, there was a problem from the very get-go, in terms of propensity to cause liver problems."
Dr. David J. Graham, the FDA's senior epidemiologist, has estimated that 20 Rezulin patients a month are suffering from liver failure.
The FDA is now investigating whether Warner-Lambert concealed findings of liver toxicity in 1994 clinical trials. |