The diabetes drug Avandia, which has been linked to an increased risk of strokes and heart attacks, is not yet off the market, but its use will now be restricted by the FDA to patients with type 2 diabetes that won’t respond to other medications.
Research has shown that Avandia, designed to control blood sugar in type 2 diabetics, puts patients at a 43% higher risk of heart attacks. Many doctors and researchers feel that this should be enough to pull it from the market altogether. Indeed:
The FDA’s move runs counter to the recommendation of a senior scientist, Dr. Gerald Dal Pan, who advised the agency to pull Avandia from the market altogether. Dal Pan heads the FDA’s Office of Surveillance and Epidemiology, which oversees the safety of drugs that have previously been approved. –CNN
The European Medicines Agency, the European equivalent of the FDA, one–upped its American counterpart by completely suspending approval for Avandia’s marketing in Europe—a crucial step toward removing the drug from the European market altogether. In a few weeks, we will know whether Avandia will indeed be banned in Europe.
In the meantime, American patients who already take Avandia are being allowed to continue taking it, if they are benefitting from the drug and acknowledge that they understand the risks associated with taking it. Those who are interested in other therapies to control diabetes can explore alternatives here.
[Dr. Steven] Nissen, the Cleveland cardiologist who became the drug’s most well-known critic, sounded a mixed note after hearing of the decisions. “It’s taken too long to stop the use of a drug that clearly was harming people. We’ve got to fix this system.” At the same time, he said he’s satisfied with the FDA and European moves. “The use of Avandia and related products will essentially cease in the U.S. and Europe. I will anticipate that 99 percent of the use of this drug will cease worldwide.” –CNN
Nevertheless, it is worrisome that the FDA won’t go the distance and pull this dangerous drug from the market altogether. Although 99 percent of patients might stop taking Avandia, this will still leave hundreds of thousands of patients taking it, and risking their lives on a daily basis to do so.