FDA Reconsidering the Safety of Avandia Drug
This June, a federal health advisory panel will meet to reconsider the safety of GlaxoSmithKline Plc’s Avandia diabetes drug. In September of 2010 the U.S. Food and Drug Administration had placed strict restrictions on the drug due to heart attacks and deaths associated with the product. Previously, the drug was only available to patients who could not control their diabetes with any other medication. According to Glaxo, only about 3,300 people in the United States still take the product. The FDA advisory panel is expected to meet on June 5th and 6th to discuss updates on safety information regarding the drug. The panel had asked Glaxo to conduct a large study of Avandia to re-examine the drug’s safety. It has also asked the company to come up with a strategy plan on the availability and use of the drug. A group of medical experts from Duke University have re-examined the study and have submitted their findings to the FDA. Researchers state that there was no major difference in cardiovascular safety between Avandia and metformin and sulfonylureas, two other widely used oral drugs.