FDA Is Urged to Pull Diabetes Drug Off Market

Although 14 people have died from liver failure while using the new diabetes medication Rezulin, a Food and Drug Administration official said the drug was worth keeping on the market.

The consumer group Public Citizen has written to acting FDA commissioner Dr. Michael Friedman demanding that Rezulin be pulled from the market.

“How many more Americans will have to die or require liver transplants before [Rezulin manufacturer] Parke-Davis and the FDA take action to protect people in this country by banning the drug?” Dr. Sidney Wolfe and Larry Sasich of Public Citizen’s Health Research Group said in a letter to Friedman. Wolfe says 21 people have died as a direct result of taking Rezulin.

The FDA could not confirm that number. “We have a count of 14 confirmed U.S. deaths that have been associated with Rezulin use,” Dr. Florence Houn, a deputy director at the FDA’s drug evaluation division, said Monday in a telephone interview.

Parke-Davis had advised doctors to monitor patients’ livers regularly when prescribing Rezulin. Wolfe said he learned the company plans to relabel the drug to recommend more frequent testing.

The doctors of the 14 people who died had not been testing their liver enzyme levels as recommended, Houn said. She says a better education campaign is needed.

Rezulin, known generically as troglitazone, has known bad effects on the liver. About 2% of patients taking the medication show an elevation of certain liver enzymes in the blood, a possible indication of liver damage.

The drug, made by Warner-Lambert Co.’s Parke-Davis unit, went on the market last year and was the first new drug developed for treating diabetes in years. It is prescribed along with insulin or older drugs known as sulfonylureas for patients whose blood-sugar levels are not being controlled by the other treatment.

In June, the U.S. National Institutes of Health stopped trials aimed at seeing whether troglitazone could prevent diabetes in people considered at high risk when one person taking the drug died after developing liver failure. Glaxo-Wellcome, which sold troglitazone in Britain, suspended sales in December.

Parke-Davis said nearly a million patients have taken Rezulin for Type 2 diabetes.