Diabetes
Drug Pargluva, About To Be Approved by FDA, Shown to Carry Deadly
Cardiovascular Risk
Diabetes Drug Pargluva,
About To Be Approved by FDA, Shown to Carry Deadly Cardiovascular Risk
A new diabetes drug manufactured by Bristol-Myers Squibb called Pargluva, recommended by an FDA panel for immediate approval, has been shown to carry with it more than double the risk of life-threatening cardiovascular
complications, including heart attack, heart failure, stroke and associated
death. Pargluva, also known as muraglitazar, was to be the first in a new class of drugs called dual-action PPARs intended for treatment of the many millions of people in the US with Type 2 diabetes, which is the most common form of diabetes. Pargluva was designed to combine in a single pill the actions of diabetes medications in general that lower the level of blood fats called triglycerides, raise what is known as "good cholesterol" and enhance the effectiveness of insulin. A group of independent researchers outside of the FDA reviewed the same studies submitted by Bristol-Myers Squibb to the FDA, found the alarming risk of heart
and vascular complications exhibited in the study, criticized the FDA for missing the severe risks associated with Pargluva use and called for a dedicated cardiovascular safety trial before Pargluva is approved. The independent researchers indicated their concerns were first aroused when the only cardiologist on the FDA panel resigned because of a conflict of interest. The panel then voted 8 to 1 to approve the drug.
If the approval of Pargluva becomes final, there will certainly be a large number of severe heart
attacks, strokes and other vascular complications and deaths associated with its use, and claims will inevitably follow. Drug lawyers nationwide are already reviewing the merits of the lawsuit that would be filed on behalf of victims. Attorneys
across the country have already filed lawsuits in recent times for tens of thousands of heart attack and stroke victims of Vioxx, Bextra and Celebrex, and with the FDA already being sharply criticized in the press,
in the medical profession and in the cases and lawsuits that have been filed for its negligent handling of safety issues in the drug approval process, it is astounding that yet another instance of a dangerous drug being prematurely released appears to
have been on the verge of taking place.
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