The United States Food and Drug Administration has passed a statement asking GSK to stop enrolling people in an ongoing trial comparing its diabetes drug Avandia (rosiglitazone) with rival Actos (pioglitazone), a Takeda Pharmaceuticals’ drug. However, the Avandia patients currently enrolled in the trial can continue to take the drug unless advised against by a doctor.

The statement also asks the British pharmaceutical giant GlaxoSmithKline to inform the 1324 already enrolled patients for the drug that Avandia may increase heart risks.

Majority of the expert advisory panelists of the agency expressed their interests in seeing tougher warnings on the label of the diabetes type-2 drug. The order came after a 19-11 vote by the panelists to keep the trial open followed by a 20-12 voting to counsel the FDA to allow the controversial drug open for patients with type-2 diabetes, albeit the notably increased heart risks linked with it.

A senate report even claims that GSK knew the heart risks associated with Avandia years before the information came out in public. The senate committee is now going for about 2 years of inquiry asking the Food and Drug Administration the reasons for allowing a trial of the drug to go on even though it was reported to have caused 83000 heart attacks from 1999 to 2007. A warning label was asked to be displayed in the year 2007 itself but no action was taken by GSK.

Avandia was among the three best-selling drugs of GlaxoSmithKline in the year 2006 with returns of $2.2 billion but the safety concerns disclosed in 2007 cut revenue to $1.2 billion by 2008 end. However, the drug was prescribed to 2.6 million Americans in 2009. GSK also reported a loss of $464 million in three months after charges of $2.4 billion towards legal expenses. This amount also includes the $460 million to resolve more than 10000 lawsuits against Avandia.

Sources:

http://www.nytimes.com/2010/07/22/business/22avandia.html?_r=1&ref=health