In a few months, the 600,000 Americans currently taking the diabetes medication Avandia will have to sign an informed consent statement indicating that they are aware Avandia may increase the risk of heart attacks and other cardiovascular problems.
The changes come on the decision of the Food and Drug Administration to limit access to the diabetes medication on September 23, 2010. The announcement coincided with a decision by the European Medicines Agency to completely suspend marketing of Avandia throughout the European Union. GlaxoSmithKline, manufacturer of Avandia, will stop promotion of the drug in every country where it operates.
The FDA’s principal deputy commissioner still encouraged people to take the medication once they have had the opportunity to consult with their physicians. After the FDA rules take effect, physicians will be required to certify that they are unable to control their patient’s blood sugar levels with other therapies and that medical problems preclude them from taking Avandia’s primary competitor, Actos.