Avandia, once the top-selling diabetes medicine around the globe, is about to largely disappear on both sides of the Atlantic Ocean.
The New York Times reports that, in an unusual coordinated move, regulators in Europe and the U.S. are taking action against the drug, which was revealed to increase the risk of heart attacks in research three years ago.
Sales will be suspended entirely in Europe. In the U.S., the Food and Drug Administration will allow sales only if doctors indicate no other drug can treat the illness and patients acknowledge that they have been warned about the substantial heart risks.
That appears to doom a drug that its maker, GlaxoSmithKline, has long defended as safe. In July, however, the FDA signaled its concern when it ordered Glaxo to stop recruiting new patients for a controversial study comparing Avandia and Actos, a similar medicine made by Takeda.
Even before the FDA decision, The Wall Street Journal reported, many doctors began steering their patients away from Avandia because of the safety concerns.
Thursday’s development, the Times said, marks a new era for pharmaceutical companies in part because Avandia’s risks became known only after GlaxoSmithKline was forced to release data in connection with a legal settlement. Public postings of such data are increasingly common – and, as a result, drug makers cannot count on being able to easily hide scientific information about their products.
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