These are not good days for GlaxoSmithKline and its diabetes drug, Avandia. The Food and Drug Administration has decided Avandia can stay on the market but must have additional warning labels and be restricted to those patients for whom other drugs do not work. Other GSK products containing rosiglitazone also face the same limitations.
The problem with Avandia may be its link to cardiovascular risks such as heart attack and stroke.
The FDA came very close to pulling Avandia off the market last July during an advisory panel meeting. The experts meeting did stop an Avandia trial called TIDE, which compared Avandia to Actos, a rival drug.
According to an FDA news release, the restrictions allow Type 2 diabetics, who are currently taking Avandia, to continue its use while use will be restricted to new patients only if they cannot control their blood sugar while on other medications and cannot take Actos.
Avandia is in a class of drugs known as thiazolidinediones or TZDs.
GSK will have to set up the limitations and doctors will have to confirm a patients’ eligibility. GSK will also have to assemble an independent group of experts to review the clinical trial known as RECORD which is completed to determine the safety of Avandia compared to other diabetes drugs. The cardiovascular safety question will be key.
It is very possible if GSK has shown bias in its study methods or results, the FDA could remove Avandia from the marketplace. If you or a loved one has taken Avandia and suffered a cardiovascular event, you should know that an experienced Florida defective product law firm will review your case at no cost to you.
