FDA Orders Severe Restrictions on Avandia
The U.S. Food and Drug Administration (FDA) has announced a harsh set of restrictions on the sale of Avandia (rosiglitazone) because of increased concern over links between serious heart problems and use of the popular diabetes drug.
Under the new rules, Avandia can only be prescribed to patients with Type 2 diabetes who cannot control their diabetes with any other medication, and even then a prescription can be issued only after the risks of Avandia use have been fully spelled out and the patient has signed a statement indicating an understanding of Avandia's health dangers.
While Avandia will remain on the market in the U.S. (subject to the restrictions detailed above), the European Union's European Medicines Agency went one step further than the FDA, deciding to pull Avandia from shelves across the continent.
To learn more about Avandia and FDA regulation of prescription drugs, check out Nolo's articles Avandia Litigation and FDA Drug Recalls. For FDA information on Avandia, go to the FDA's website at www.fda.gov.