FDA Is Urged to Pull Diabetes Drug Rezulin Off Market; 14 Deaths Cited

WASHINGTON — 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.

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.