The latest in a series of troubling developments for the manufacturers of the diabetes drug Avandia comes in the form of a new report suggesting that pharmaceutical company GlaxoSmithKline (GSK) knew of the cardiac risks associated with the drug even before the public became aware.
Intended to help diabetes sufferers through better blood sugar regulation, the drug has unfortunately been at the heart of a number of reports of life-threatening complications including heart disease and pulmonary edema. The drug already contains a “black box” warning, a labeling requirement prescribed by the FDA only in cases of the most severe potential side effects, the strongest warning that can be placed on a legal drug.
Most recently, senators Max Baucus and Charles Grassley released a 2008 memo from the Food and Drug Administration (FDA) that stated that there was “strong evidence” that Avandia confers an increased risk of heart failure when compared to a competitor. At the time, FDA reviewer Dr. David Graham argued to an advisory panel that Avandia should be pulled from the market and sales stopped.
The senators’ report speculates that GSK may have known “several years prior” of these possible cardiac risks and may even have “attempted to intimidate independent physicians … to downplay findings.” GSK has denounced the findings, saying that the report mischaracterizes their research efforts.
Though the FDA has stated that patients already on the drug should not stop taking it without consulting a doctor, they are convening a new advisory panel of outside experts to reconsider the safety issues associated with Avandia. Unfortunately, this closer scrutiny may come too late for patients who have already suffered harmful side effects. Many of these victims have already been seeking out assistance from a number of different Avandia law firms helping those harmed by the diabetic drug.
Tags: Avandia law firms, diabetes drug, FDA, GlaxoSmithKline, pharmaceutical, speculates
