Heightened US drug safety concerns reach another critical testing point on Monday when a regulatory advisory panel weighs the heart risks and future of GlaxoSmithKline's diabetes drug, Avandia.
The Food and Drug Administration will convene an experts' panel to recommend whether the UK drugmaker's drug increases the risk of heart attacks and if it should remain on the market. The FDA routinely follows the recommendations made by its advisory panels, comprised of outside medical experts.
Regulation and questions over drug safety and risks have intensified in the aftermath of US drugmaker Merck's sudden withdrawal of Vioxx three years ago because of heart risks.
The FDA continues to come under pressure and scrutiny from Congress, patients groups and doctors to improve its drug-safety monitoring. Legislation is pending that could change the FDA so as to improve safety oversight.
Questions over Avandia have put the US commercial future of one of GSK's best-selling drugs in jeopardy.
The controversy exploded into the public in May. In an article in the New England Journal of Medicine, Dr Steven Nissen, a renowned US cardiologist, estimated that there was a significant increase in heart attack risk for Avandia patients by an overarching analysis of data from 42 previous clinical trials. Dr Nissen had been a major voice against Vioxx risks.
GSK and the FDA had already been evaluating data on Avandia risks and negotiating some changes to its prescription label directions.
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Aside from the direct impact on sales, GSK is also facing the possible threat of costly litigation from users of the drug who claim to have suffered heart problems. David Vermont, a lawyer with Ashcraft & Gerel in Washington, one of several American law firms preparing legal action against GSK, said that it had already screened up to 300 inquiries from Avandia patients and their families, 80 per cent of whom he said had experienced heart attacks.
“We are getting calls and referrals every day — twice as many as we would have expected,” Mr Vermont told The Times.
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