GlaxoSmithKline's (GSK) diabetes drug Avandia got hit with a double whammy from regulators on both sides of the pond Thursday. The European Medicines Agency announced plans to yank the drug from the market in the coming months, while U.S. officials placed greater restrictions on its use.
The U.S. Federal Drug Administration said it will limit new Avandia prescriptions to patients with Type 2 diabetes who either can't control their illness with other medications or who can't take Actos, another medication designed to treat diabetes. Patients with Type 2 diabetics can no longer process insulin properly and gradually lose the ability to produce enough to regulate their blood-sugar level.
Current Avandia users will still be allowed to continue taking the drug if they find it beneficial and are aware of the potential health risks. The FDA cited data suggesting that patients being treated with Avandia have a higher risk of heart attacks and strokes. Avandia users face a 43% increased risk of having a heart attack, according to a 2007 New England Journal of Medicine study (via Bloomberg).
But some critics may think the FDA hasn't gone far enough. In July, when an FDA panel debated the future of Avandia in light of reports questioning its safety, several senators and medical experts called for the drug to be pulled from the market. But the FDA has stopped short of those measures. And GlaxoSmithKline says it will stop promoting the drug, according to Bloomberg.
Europe to Pull Avandia Off Shelves
Meanwhile, in Europe, sales of Avandia, as well as Avandamet and Avaglim, all which contain rosiglitazone, will be halted in the next several months, according to an announcement by the European Medicines Agency. The agency cited concerns about fluid retention and the increased risk of heart failure for those taking the medications.
Although the agency had previously taken steps to limit the use of rosiglitazone and the three diabetes medications, it says it became clear that further action was needed.
"In view of the restrictions already in place on the use of rosiglitazone, the committee could not identify additional measures that would reduce the cardiovascular risk," the agency said of its Committee for Medicinal Products for Human Use. The Committee concluded that the benefits of rosiglitazone no longer outweigh its risks.
This means that fewer diabetes treatments are available to patients when they're needed more than ever. Diabetes has skyrocketed in the last few decades, growing from 5.6 million Americans with some form of the disease in 1980 to 17.5 million in 2007, according to the Centers for Disease Control and Prevention.