WASHINGTON — A new diabetes drug on track to win approval from the Food and Drug Administration (FDA) more than doubles the risk of death, heart attack and stroke, a finding that renews concerns about the government's safety screening for new medications.

Researchers at the Cleveland Clinic analyzed data provided to the FDA by the drug's manufacturers and found that the drug, Pargluva, also increased the risk of congestive heart failure and mini strokes.

The study was published online yesterday by the Journal of the American Medical Association, just days after the FDA had issued a letter notifying Bristol-Myers Squibb and Merck that their drug was "approvable" once some follow-up safety information was provided. An FDA advisory committee, in an 8-1 vote, recommended approving Pargluva for Type 2 diabetes last month.

The medical journal said it moved up the publication of the study because of its "timeliness and potential importance for public health."

Dr. Steven Nissen, lead author of the study, said the failure of the FDA panel to recognize the drug's health risks shows a continuing weakness in the government's drug-approval process.

"I think the FDA advisory committee was asleep at the switch," Nissen said. "The question is, did they not get it, or did they get it and were not willing to stand their ground?"

In an editorial accompanying the study, Dr. James Brophy of McGill University said the drug makers skewed the data to play down Pargluva's safety risks. He said they excluded many patients with existing heart troubles and included other patients who took dosages well below the levels they planned to market to make Pargluva seem safer.

David Rosen, a spokesman for Bristol-Myers Squibb, said the company still was examining the new journal reports and wasn't ready to comment. But he said the safety and efficacy studies of Pargluva were conducted by "outside experts and thought leaders in diabetes treatment."

"These trials that were conducted on Pargluva were designed like other clinical trials for a diabetes drug," Rosen said.

Merck issued a statement saying, "Pargluva was extensively studied and all available data were reported to the FDA."

The FDA said it could not comment on Pargluva because its application was still pending. But the agency said it had launched initiatives to better monitor cardiovascular safety with all medications.

Pargluva is considered a promising drug for Bristol-Myers Squibb and Merck, and was expected to generate annual sales of $300 million to $900 million, according to Wall Street analysts.

The drug, generically known as muraglitazar, is the first of a new family of drugs designed to combat Type 2 diabetes, which affects more than 16 million Americans, according to the Centers for Disease Control and Prevention. Type 2 diabetes is associated with obesity and occurs when the pancreas reduces its output of insulin or when cells elsewhere in the body become resistant to the effects of insulin.

There are several drugs on the market to increase a patient's sensitivity to insulin or combat the high-cholesterol problems that often accompany diabetes. Pargluva is the first combination drug to tackle both problems at once.