Quoted from http://www.reuters.com/article/idUSTRE68M28H20100923
EU pulls plug on Glaxo's Avandia, FDA restricts
Pharmacy staff holds a package of the diabetes drug Avandia in a pharmacy in Berlin, July 14, 2010.
Credit: Reuters/Thomas Peter
By Ben Hirschler and Lisa Richwine
LONDON/WASHINGTON | Thu Sep 23, 2010 6:40pm EDT
LONDON/WASHINGTON (Reuters) - European officials moved to pull GlaxoSmithKline's diabetes drug Avandia off the market and U.S. authorities imposed tight restrictions over heart risks, effectively spelling the commercial end to the once-lucrative medicine.
Once a top treatment choice and Glaxo's No. 2 seller, the rulings attempted to resolve a bitter, three-year debate over Avandia's safety that has dogged the reputation of the medicine and its maker, and divided staff inside the U.S. Food and Drug Administration.
The moves cleared the way for newer diabetes treatments to gain market share. Merck & Co's drug Januvia and AstraZeneca Plc and Bristol-Myers Squibb Co's Onglyza were most likely to see a boost, analysts said.
In coordinated statements, the FDA in Washington and the European Medicines Agency (EMA) in London said they agreed on the heart risks associated with the drug but had reached different conclusions on action.
The EMA said it would move to ensure Avandia was off the market in the next few months, while the FDA will require that U.S. patients first try other medicines to control blood sugar and acknowledge that they understand Avandia's risks.
"Essentially the drug is gone," Dr. Steve Nissen of the U.S. Cleveland Clinic said in an interview. He predicted about 99 percent of Avandia use would end within six months. "That's a good outcome."
Nissen's 2007 study linking Avandia to a higher risk of heart attacks prompted safety reviews.