GlaxoSmithKline faces new Avandia criticism

22nd Feb 2010 12:27

GlaxoSmithKline has revealed more potential problems in the US, this time for its controversial diabetes medicine Avandia. A report from the US Senate cites studies from the US Food and Drug Administration that called for the drug to be pulled from the market because of a possible link to heart illness. The studies were released as part of a report on Avandia by Senate Finance Committee members Chuck Grassley and Max Baucus. GlaxoSmithKline replied that it has extensively studied Avandia in more than 52,000 patients and none of its reports shows a statistically significant association between the drug and heart attacks. Concern over Avandia surfaced in 2007 following a study by Cleveland Clinic cardiologist Steve Nissen in the New England Journal of Medicine. Since then, sales of the drug have declined sharply, but analysts say the Senate report may increase the chance of litigation against the company.The Senate report suggests that says that rather than warn patients, GlaxoSmithKline tried to down play the heart disease risk and "sought ways to downplay findings that the rival drug Actos might reduce cardiovascular risk".Last Friday, GlaxoSmithKline had to defend its best-selling asthma drug Advair after the Food and Drug Administration proposed changes to the labelling for asthma medications containing long-acting beta-agonists (LABAs).