German drug watchdogs aren't waiting around for the U.S. FDA to air Avandia concerns at next month's advisory panel meeting. The Federal Joint Committee simply told health insurers to stop paying for the GlaxoSmithKline diabetes drug altogether. Now.
That committee, whose decisions are widely followed, cited the risk of bone fractures and heart problems in recommending against reimbursement for the drug, Reuters reports. Glaxo fired back, saying, "The committee's course of action is not justified neither from a medical, nor legal point of view."
If there's any consolation for Glaxo, it's the fact that the committee's recommendation covers the entire class of drugs known as glitazones, including Avandia's chief competitor Actos, sold by Japan's Takeda Pharmaceutical. And the group said Novo Nordisk's diabetes pill NovoNorm/Prandin and the rest of its class--known as glinides--should be left out in the cold, too.
Of Avandia and Actos, committee chair Rainer Hess said (as quoted by Reuters), "There are other pharmaceuticals that have no such side effects and long-term risks. We believe that patients should be protected against useless and, more importantly, harmful therapies."
As you know, new concerns about Avandia safety are set for discussion at an FDA committee meeting next month. Among the data to be discussed: An unpublished study that highlights a 27 percent increase in the risk of stroke and 25 percent increase in heart failure risk with Avandia use. No doubt the committee will also discuss that much-publicized Senate committee report that questioned Glaxo's handling of safety data on the drug. We'll have to wait and see what they decide.