Avandia Safety – review by FDA
Previously on the Important Lawsuits website we reported that lawsuits regarding the diabetes drug Avandia were being filed by consumers. Now there is new information from the FDA regarding the safety of Avandia.
FDA scientists have reviewed information provided by the drug’s maker GlaxoSmithKline in anticipation of a meeting being held starting on Tuesday. A panel of physicians will be meeting and voting on a wide range of recommendations regarding Avandia including:
- Adding warning labels in addition to the ones already included with the product,
- Putting a limit on what doctors will be able to prescribe the drug, or even
- Pulling the drug from the market altogether.
The panel of doctors who will be voting on the recommendations are outside experts. The FDA is engaging these outside experts because there has been some disagreement among FDA scientists regarding Avandia. Dr. Janet Woodcock, head of the FDA’s drug center, stated that there was not “complete unanimity within the FDA” regarding interpretation of data on this drug.
In June of 2010 there was an article published that suggested Avandia is more likely to cause strokes and heart related deaths than a rival drug, Actos. However, some experts will say that people who take Avandia (those suffering from Type 2 Diabetes) have an increased risk for heart problems.
It will be interesting to see what the FDA does after hearing the recommendation from this outside panel of experts. The FDA is not required to follow their suggestions.
UPDATE 7/15/2010: The panel convenied by the FDA has voted to allow Avandia to remain on the market. However, the panel stated that stronger “black box” warnings were needed. Read more about this on the Wall Street Journal’s website by clicking the link here.