The FDA has posted an in depth 700 page review of the once popular diabetes drug Avandia. This GlaxoSmithKline product was once a number one seller, however it has fallen out of favor due to reports and warnings issued concerning the relation of this medication to heart problems.
There will be an FDA meeting next week to discuss the information included in the review and decide whether to allow Avandia to remain on the market. This is a difficult decision for the FDA, but one that is becoming familiar. The FDA approved Avandia a decade ago, and now it appears to be tied to deadly heart issues.
There have been dozens of studies conducted concerning Avandia, including one that the manufacturer has pointed to as support for the safety of the drug, each of these have been reviewed by the FDA.
Essentially Avandia works by increasing the body’s reaction to insulin. Insulin is a key protein required for digestion that diabetics don’t produce naturally. This means that people with diabetes can’t break down carbohydrates completely because of the imbalance in their bodies related to insulin, whether a lack of insulin or a resistance to insulin. Because of this diabetics are at a higher risk of heart problems, blindness, kidney issues and other serious health concerns.
FDA reviewers have said that the chief trial presented by GSK was “inadequately designed and conducted to provide any reassurance” about the safety of Avandia for the heart. A two day meeting will commence on Tuesday to decide what a panel of outside physicians recommend as a course of action concerning Avandia. While the FDA is not required to follow the recommendation of the panel, it usually does. This same group of experts met in 2007 concerning Avandia as well. At the time they voted 22-1 to keep Avandia on the market. The new data and pressure from politicians has prompted the FDA to again examine the safety of Avandia. The possible results of the panel include:
Adding additional warnings to the drug.
Placing limits on which doctors can prescribe the medication.
Removing the drug from the market completely. Like many drugs introduced in the 1990’s Avandia was approved due to smaller studies which showed the effectiveness of the drug to help control the level of blood sugar in diabetics. This is the key measure for a diabetes medication. But the studies weren’t large enough to detect the many possible side effects of the drug.