Rezulin’s Maker Now Says Drug Linked to as Many as 35 Deaths

The manufacturer of the diabetes pill Rezulin now believes that the drug has been linked to the deaths of as many as 35 patients, company representatives said Thursday.

“To the best of our knowledge, the number is between 33 and 35 patients,” said Stephen J. Mock, a spokesman and vice president of New Jersey-based Warner-Lambert Co.

That figure would be an increase from the 26 Rezulin-related deaths that Warner-Lambert acknowledged in a Dec. 31 filing with the Food and Drug Administration. The drug went on the market in March 1997 and was withdrawn in Britain in December 1997 because of concern about liver toxicity.

The FDA is reassessing the safety of Rezulin, and the drug will be the subject of a meeting March 26 by the agency’s Endocrinologic and Metabolic Drugs Advisory Committee.

The FDA late last month told Rep. Henry A. Waxman (D-Los Angeles) that as of Feb. 3 it was aware of 100 Rezulin patients who suffered “liver adverse events with a fatal outcome.” The agency described 33 of these deaths as “associated” with the use of Rezulin, without providing its methodology or criteria for excluding the other 67 deaths.

Based on a computer-assisted analysis of records obtained from the FDA, The Times on Thursday disclosed that doctors, nurses and others have reported 155 deaths in which Rezulin was cited as a suspect drug.

Among the 155 deaths counted by The Times study, some of the patients also had other preexisting medical conditions that could have contributed to or caused death, according to the reports. These health problems, which may or may not have been linked to the drug, included heart attacks, strokes and cancer.

Warner-Lambert and other proponents of Rezulin said that the drug is effective and safe when used with regular liver-function monitoring.