Finding the right drug to battle diabetes has always been a dilemma amongst diabetics. There are many factors to consider, such as making sure the diabetes drug effectively helps you, while also making sure the drug does not have any unwanted health deficiencies. The FDA is currently in an advisory committee meeting where they will decide whether to lift the marketing restrictions placed upon GSK’s (GlaxoSmithKline) once popular diabetes drug Avandia.
Diabetes Drug Likely Better Than Expected
This diabetes drug was involved in one of the bigger drug controversies when it was withdrawn in Europe. Use diminished in the US after it was found that the diabetes drug could increase the risk of heart attack or stroke. This hearing is in response to a review of GSK’s clinical trial referred to as “Record”, which supports approval of the diabetes drug. GSK concluded from this study that the heart risks found from Avandia might not be as extreme as previous studies suggest.
Not Avandia’s First Rodeo
This is not the first time the Avandia diabetes drug faced controversy. The FDA had approved the drug in 1999, but then was highly criticized in 2007 after it was found that the drug could cause cardiovascular problems. Instead of banning the drug outright, the FDA placed restrictions determining how it could be prescribed. Even though the FDA and Record are being faced with severe criticism, the FDA says that the study should be reviewed.
A review of the study by Duke Clinical Research Institute has been completed and supports the original claim that the Avandia diabetes drug is not as big of a risk for heart problems to warrant the restrictions imposed by the FDA. Even though Avandia was once the worlds best selling diabetes drug for type 2 diabetics, GSK has stated that even if the restrictions are lifted, they have no intentions of promoting the diabetes drug again.