The following article appeared in the Science / Health Section of the February 23,   2000 edition of the New York Times.



February 23, 2000

Review on Risks of Diabetes Drug

By Holcomb B. Noble

The Food and Drug Administration is investigating a recent increase in deaths caused by the diabetes drug Rezulin, an agency spokesman said yesterday.

Rezulin is now reported to have caused 58 deaths and necessitated 10 liver transplants among 85 patients who suffered from liver failure since the drug's approval in 1997. Both the number of reported deaths and the cases of liver damage have doubled since March, agency officials said.

The Los Angeles Times reported on Saturday that the medical officer most closely involved with the government's rapid approval of the drug, Dr. Robert I. Misbin, told his bosses at the F.D.A. that he saw no reason the agency should delay removing the drug from the market.

Otherwise, Dr. Misbin said, "additional cases of preventable liver failure" may occur, the newspaper said.

The F.D.A. spokesman said Dr. Misbin declined interviews on the Times report.

Rezulin was approved because of its life-saving potential for patients with severe diabetes, and it was known at the time that it presented a risk of producing liver damage.

This prompted the F.D.A. to issue repeated warnings to doctors to monitor patients who were taking it. But an agency investigation last winter found that only 2.7 percent of patients taking Rezulin for three months were being monitored in the close way the agency had

A panel of independent experts has recommended that the drug be prescribed only to patients who do not respond to other therapies.

At an F.D.A. hearing in March, Rezulin's manufacturer, Parke-Davis, a division of the Warner-Lambert Company of Morris Plains, N.J., agreed with reports from doctors and drug companies that 43 people who took the drug had suffered acute liver failure and that 28 had died.

Janet Woodcock, the director of the agency's drug review center, said the F.D.A. continually evaluated the risks and benefits of drugs.

The agency considered it prudent to keep Rezulin on the market, as long as it was used according to recommendations and approved labeling, Ms. Woodcock said.


Copyright 2000 The New York Times Company