Problems with Avandia Continue to Mount for GlaxoSmithKline

As the push to recall Avandia in the United States continues to pick up steam, German medical officials have determined that the health risks associated with GlaxoSmithKline’s diabetes drug make the medication “useless” and “harmful,” leading to a recommendation that the nation’s insurers should stop paying for its use.

The move by Germany’s Federal Joint Committee, consisting of doctors and health insurers, is the latest blow to GlaxoSmithKline’s attempts to keep Avandia on the market. In reaching its decision to tell insurers not to offer Avandia reimbursements, the committee cited growing evidence that side effects of Avandia cause heart problems. The move is almost certain to kill Avandia sales in Germany.

In the United States, the FDA is currently reviewing the safety of Avandia, and is planning to hold meetings next month to consider what should be done to protect consumers. Some officials within the FDA have been calling for an Avandia recall for several years, suggesting that strokes and heart attacks from Avandia may be responsible for the death or serious injury of more than 100,000 Americans since the medication was first approved.

Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years following a May 2007 publication in the New England Journal of Medicine that identified an increased risk of heart attacks and congestive heart failure with Avandia.

In recent months, there have been calls from consumer advocates and researchers for the FDA to halt an ongoing Avandia study, suggesting that it is unethical and dangerous for the trials to continue given the known risk of problems with Avandia. Critics are also concerned that many of the test subjects are being recruited in developing countries where people may not be as informed about the risk of Avandia problems.

Earlier this year, Saudi Arabia issued an Avandia ban for at least six months while it investigates the safety of the drug. The Saudi Food and Drug Authority (SFDA) determined that it appears the risks of Avandia side effects outweigh the benefits, and decided there were safer drugs on the market that its citizens could use.

GlaxoSmithKline PLC currently faces about 13,000 Avandia lawsuit claims filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious side effects. The federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania.

Over the last two months, GlaxoSmithKline has reached Avandia settlements in about 5,700 of those lawsuits for undisclosed amounts. The first Avandia trial is now expected to begin in October 2010, unless additional settlements are reached.