Researchers with the Cleveland Clinic analyzed the data on the drug, developed by Bristol-Myers Squibb and Merck & Co., which the FDA made public before the panel vote.
The data shows patients taking Pargluva face double the risk of death, heart attack or stroke, compared to those on dummy pills or a similar drug.
Dr. Steven Nissen, a prominent heart specialist with Cleveland Clinic, says if the analysis is correct, the drug could have meant a "public health catastrophe."
The drug's makers have reportedly received an "approvable" letter from the FDA that also asked for more safety data on the drug's cardiovascular effects.
An FDA spokeswoman tells The Associated Press
The non-insulin drug in question is designed to lower blood sugar levels and increase levels of "good" cholesterol in patients with Type 2 diabetes, the most common form of the disease, which affects about 18 million Americans.
The analyzed data involved 3,725 patients who were given Pargluva, a similar drug called pioglitazone, or dummy pills in a variety of studies lasting from 24 weeks to 104 weeks.
Deaths, heart attacks or strokes occurred in 35 of the 2,374 Pargluva patients, versus nine of 1,351 patients in a combined group on the other drug or dummy pills. Slightly higher risks for mini-strokes and heart failure were also found among Pargluva patients.
The analysis was published Thursday morning on the Journal of the American Medical Association's Web site.
