The Food and Drug Administration panel voted on Wednesday to recommend that GlaxoSmithKline PLC’s diabetes drug, Avandia, remain on the market despite a number of concerns that have been raised about the medication. Twenty members of the 33 person panel voted to keep the drug on the market amid the concerns. Most said that the product should have a number of addition restrictions applied to the box and commercials to make users aware of the side-effects that the drug can have for individuals with diabetes. They also stipulated that Avandia should only be used if other medications have been used before and did not provide the results that the patient required.
21 members of the panel said that they thought clinical data showed the Avandia increased “Ischemic CV events” that are relative to Actos, a similar drug that posed a number of problems itself. The safety concerns first came to light in 2007, and have continued to become a bigger issue since that time.
Some of the problems that patients have experienced include heart failure and excess fluid retention. These problems have been long-associated with Avandia and Actos, and both products already carry the toughest FDA warning discussing that risk.
A number of studies have been released that show how risky that medication can be for some individuals. FDA officials have questioned the integrity of some of the recently released studies, because they say that they number of individuals that participated in the studies was not high enough.