In the wake of a study that found increased risk of cardiovascular problems with Avandia, the FDA is considering more stringent standards regarding how and when diabetes drugs will be tested for risks to the heart, according to Forbes.
Two drug safety advocates, who played a role in the debate over GlaxoSmithKline’s Avandia, praised the draft results that were circulated by the FDA on Feb. 29.
Investors got a sense of the downside of the new regulations as shares of Amylin Pharmaceuticals, a maker of diabetes drugs, fell to a 30-month low after financial analysts speculated that the new guidance could slow up the approval of a key drug, Forbes reported.
Steven Nissen, head of cardiology at the Cleveland Clinic, was the lead author of the study in the New England Journal of Medicine, which found that Avandia increased the risk of heart attacks and strokes by 40 percent.
Nissen called the new guidance “a definite step in the right direction.” He identified it as a compromise between insisting that all the data are available when a medicine is approved that might make drug development so expensive that new treatments will not make it to market, and the current situation of not having big studies start until years after a medicine hits pharmacy shelves, according to Forbes.
An FDA spokeswoman told Forbes the guidance did not result from the controversy.