Avandia Should Stay on Market, But Restrict Sales, FDA Advisory Panel SaysJul 15, 2010 | Parker Waichman LLP
While Avandia poses “significant safety concerns,” a sharply divided Food & Drug Administration (FDA) panel voted that the controversial diabetes drug should be allowed to stay on the market. However, the panel of outside experts also said sales of Avandia should be restricted.
The votes came at the end of a two-day meeting where GlaxoSmithKline, Avandia’s maker faced tough criticism for the way it handled the drug and its cardiovascular risks.
According to The New York Times, 12 of the panel’s 33 members voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged.
The FDA is not required to follow the recommendations of such panels, but does so in most cases. However, the lack of unity among panel members in the case of Avandia makes it hard to predict what the agency will do, The Times said.
Avandia was the biggest selling diabetes drug in the world, until 2007 when a Cleveland Clinic study raised questions about its heart risks. The study, conducted by Dr. Stephen Nissan, showed patients taking Avandia had a 43-percent higher risk of having a heart attack. The drug’s label has borne a black box warning – the FDA’s most serious safety alert – regarding its heart attack risk since November of that year.
Last month, Nissan released a follow-up to that study, which found an increased heart attack risk of 28 percent. The update was among the evidence presented to the FDA advisory panel.
Also considered by the panel was a study conducted by Dr. David Graham, an FDA researcher. That study, which involved 227,500 Medicare patients, found that those who took Avandia were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took another drug called Actos.
An Avandia study called RECORD, which was funded by Glaxo and used to tout the drug’s safety, was sharply criticized during the two-day meeting, with Graham telling the panel: “You can’t trust it, and if we do trust it, we’re engaging in the willing suspension of disbelief.” He also characterized RECORD as “garbage”.
Last week, a memo in a 756-page briefing document posted to the FDA Web site characterized RECORD as “inadequately designed and conducted to provide any reassurance about the CV (cardiovascular safety) of rosiglitazone.” The memo further states that the RECORD results “confirm and extend the recognized concerns regarding heart failure” and possibly suggest an increased risk for heart attacks.
According to an earlier New York Times report, the FDA review of RECORD found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial’s tally of adverse events, mistakes that further obscured Avandia’s heart risks.