FDA Eases Restrictions on Glaxo Diabetes Drug Avandia

U.S. Food and Drug Administration said Monday that it is removing some restrictions on the prescription of GlaxoSmithKline Plc's Avandia- a diabetes drug. The agency eased rules on the drug's use after studies showed that it doesn't increase heart attack risk.

Avandia (rosiglitazone) is used to treat diabetes type-2. The drug is often prescribed to people who have stopped responding to other medicines that control blood glucose levels. It belongs to a class of medications called thiazolidinediones and works by making the body sensitive to insulin, a hormone that controls blood sugar levels.

FDA announced its decision to ease Avandia's use after recommendations by a 26-member panel of experts endorsed the safety of the drug, June 6, AFP reported.

The agency reviewed data from a large study called Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) and found that people using Avandia did not have an elevated heart attack risk when compared with people using other diabetes drugs.

"Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, according to a statement. "Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions."

The FDA move means that the drug will no longer require a warning about its effect on cardiovascular health.

Avandia was one of Glaxo's best-selling medicines, with sales of about $3.2 billion in 2006. The drug was removed from European markets and was placed under many restrictions in the United States in 2010, Reuters reported. The use of the drug was questioned after a meta-analysis conducted in 2007 by Dr. Steven Nissen, head of cardiology at the Cleveland Clinic was published.

"GSK welcomes the decision of the FDA and appreciates the Agency's robust review of the science with regard to Avandia.  GSK maintains its view that Avandia is a safe and effective treatment for Type 2 diabetes when used appropriately," the company said in a statement to media.