Glaxo Adds Safety Restrictions to Avandia Label

GlaxoSmithKline PLC said Monday it has updated the labeling of its diabetes pill Avandia to include safety restrictions ordered by federal health authorities because of the drug's links to heart attack.

The Food and Drug Administration announced the changes in September as the last in a series of safety actions against the former blockbuster drug, which has triggered thousands of patient lawsuits and a Department of Justice investigation. The European Union has banned the drug.

The new U.S. label indicates that Avandia is only intended for patients who cannot control their blood sugar with any of the other diabetes medications on the market. Patients who are currently on the drug can continue taking it after consulting with their doctor.

While there are more than a dozen diabetes drugs on the market, only Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia. U.S sales of Actos have risen steadily — hitting $3.4 billion in 2009 — as Avandia's reputation has soured.

The FDA first approved Avandia in 1999 and it became the top-selling diabetes pill in the world, with more than $3 billion in sales by 2006. But use has plummeted since a 2007 analysis first linked the drug to heart attack.

Determining Avandia's heart risk was a painstaking process that dragged on for years because most patients taking the drug are already predisposed to heart problems due to diabetes.

More than 900,000 U.S. patients filled prescriptions for Avandia in the first half of 2010, according to health data firm IMS Health. That number is expected to shrink as the new FDA restrictions go into place.

London-based Glaxo reported late last year that the Justice Department and several state attorneys general are investigating the development and marketing of Avandia. A Senate investigation released last year concluded that Glaxo knew about the risks of its drug years before they were made public and withheld important data from the FDA.

The company has reportedly settled thousands of personal injury lawsuits filed by Avandia patients, though Glaxo executives say a number of additional lawsuits have been filed since the FDA's announcement last year. They have not specified the number.
U.S.-listed shares of GlaxoSmithKline PLC rose 75 cents to $38.76 in afternoon trading.