Restrictions apt to cut Avandia sales

Never ceases to amaze me that drugs that are so dangerous are allowed to even get on the market... All the best Lou & Debbie The diabetes drug is now meant only for those who have no other alternative.

Associated Press / February 8, 2011

WASHINGTON — GlaxoSmithKline PLC has updated labels for its diabetes pill Avandia to include safety restrictions because of the drug’s links to heart attacks.

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

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

The FDA 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 its use has plummeted since a 2007 analysis linked the drug to heart attacks.

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

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

The company has reportedly settled thousands of personal injury lawsuits.