Pharma biggie GlaxoSmithKline has already been slapped upside the head with a $3 billion settlement with the federal government regarding the marketing of, among others, the once-popular diabetes drug Avandia. Today, the attorneys general of 37 states rubbed a bit of salt in the wound with a $90 million settlement of their own. [More]
For several years, prescription diabetes medicine Avandia has been at the center of a debate about whether the medication’s heart attack risk was high enough to pull it from pharmacies. Now, nearly eight months after the FDA announced it would be introducing strict restrictions on its sale and use, the agency has finally gotten around to announcing the specifics of those restrictions.
Warning that the diabetes medication Avandia increases patients’ risk of heart problems and strokes, the Food and Drug Administration threw a set of cuffs on the drug. It will still be available, but only as a last resort for those who go through several other methods of battling the disease.
Today, an advisory panel met to discuss and vote on whether or not to recommend if the FDA should pull diabetes drug Avandia from the market over a possible link to increased risk of heart attacks. In the end, the voting leaves no definite direction for how the FDA will ultimately come down on the issue.
A new report from the Senate Finance Committee alleges that drug company GlaxoSmithKline not only knew about a possible link between their diabetes medication Avandia and heart attacks, but also acted to keep the FDA from pulling the drug off shelves. If so, how were they able to do it?
Since the study was published, Consumer Reports has come out in favor of older drugs:
Diabetes drugs received wide attention last spring when research found a possible link between rosiglitazone (Avandia) and a higher risk of heart attacks. While those risks remain unclear, the CR Best Buy Drug report cites other reasons that rosiglitazone and the related drug pioglitazone (Actos) are not wise first choices for most people with diabetes, including their higher risk of heart failure compared with other diabetes drugs.
Consumer Reports that patients should first ask their doctors about metformin (Glucophage and generic), claiming that the effectiveness of the older drugs are equivalent to the newer ones, but with less potential risk.
The study was outed yesterday on the New England Journal of Medicine’s website. The editors of the journal and the study’s lead author both warned that the research methodology left the “findings open to interpretation.”