• Defective Drug Side Effects

Find a Lawyer in Your State

Need Help?

Pargluva, a new diabetes drug that seemed headed for Federal Drug Administration approval has been linked to serious side effects including death, heart attacks and strokes. The FDA has held off the drug''s approval, though only after recent studies showed the problems. Last month the FDA gave conditional approval for the drug.

Pargluva, generic for muraglitazar, is a pill used in treating Type 2 diabetes. Type 2 diabetes is the most common form of diabetes and is found prominently in people who are overweight.

The Journal of the American Medical Association (JAMA) posted the unsettling findings of the study early, in hopes of staving off a potentially deadly drug from entering the market.

Merck, already facing controversy over its painkiller Vioxx, and Bristol-Myers Squibb jointly manufacture Pargluva. Dr. Catherine DeAngelis, JAMA''s editor-in-chief criticized the FDA''s willingness to approve the drug after the national spectacle of deaths related to Vioxx and other painkillers.

Some 18 million Americans struggle with diabetes, meaning that the market is desperate for some medical help. Pargluva allegedly would not only lower glucose levels in the blood, but also would diminish fatty triglycerides and increase levels of good cholesterol. It would be the first drug to do all three things at once.

Deaths, heart attacks, and strokes occurred in 35 of 2,374 tested patients who were taking Pargluva. Only five instances occurred in 1,351 control group patients. The study shows contrary evidence to that presented to the FDA that said there was no significant risk of death or heart problems.

The drug was forecast to make Merck and Bristol-Myers Squibb $1 billion a year in additional revenue.

Pargluva''s entry onto the drug market is likely delayed now for up to a year.