The FDA has spoken--and GlaxoSmithKline is breathing a sigh of relief. The agency did stiffen warnings on the embattled diabetes med Avandia, but it shied away from linking the drug to heart attacks more directly than its competitors. "There isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments," the FDA stated. As part of its deal with the agency, GSK has agreed to stage a head-to-head clinical trial pitting Avandia against Takeda's Actos. The trial would gauge both meds' risk of cardio problems.
The FDA also is requiring Avandia rivals to note on their labels that no oral diabetes med has been shown conclusively to cut diabetes patients' risk of heart problems. The upshot of the new wording? A muddle, The New York Times says. As one blogger noted, the FDA's decision falls close to European regulators' position on the warning spectrum. The European Medicines Enforcement Agency kept Avandia on the market without adding warnings at all. In contrast, Health Canada last week set out some strict limitations for Avandia use, warning heart failure patients to stay away from the drug completely.
Will the less-stringent-than-feared warning help revive Avandia sales, though? Analyst opinions are mixed. Meanwhile, consumer groups are still warning patients against the drug. Rest assured that lots of eyes will be watching those sales trends.