US FDA committee favours keeping Avandia on the market
An independent committee of experts consulted by the US Food and Drug Administration ruled in favour of keeping the diabetes drug Avandia.
WASHINGTON: An independent committee of experts consulted by the US Food and Drug Administration ruled in favour of keeping the diabetes drug Avandia on the market despite its increased risk for heart problems, an FDA spokesman has said.
By a 20-3 vote, the FDA Advisory Committee agreed that current clinical trials showed Avandia, produced by GlaxoSmithKline, increased the risk of heart attack in people suffering from type 2 diabetes, said Sandy Walsh yesterday.
The experts also concluded by a 22-1 vote that the therapeutical benefits of Avandia outweighed its risks and justified keeping it on the market.
The panel's decision is non-binding, although the FDA usually follows its recommendations.
A study in the May 21 issue of the New England Journal of Medicine showed Avandia users -- more than seven million around the world -- had 43 per cent greater risk of heart attack than normal.
Based on a review of 42 earlier studies, the preliminary results of the research conducted by renown Cleveland Clinic (Ohio) cardiologist Steven Nissen were disputed by GlaxoSmithKline.