Reports raise fresh Avandia safety questions
pharmafile | February 23, 2010 | News story | Research and Development, Sales and Marketing | Avandia, GlaxoSmithKline, diabetes
GlaxoSmithKline’s troubled diabetes drug Avandia has been hit by fresh reports from the US that it increases the risk of heart attacks and heart failure.
FDA reports obtained by the New York Times say that if every diabetic currently taking Avandia (rosiglitazone) were instead given Takeda’s Actos (pioglitazone) about 500 heart attacks and 300 cases of heart failure could be averted every month.
Rumblings from the US over the safety of Avandia are not new, in 2007 a study suggesting a link between heart attacks and the drug prompted the FDA to issue a formal safety warning.
Later the year an independent committee found Avandia did increase the risk of heart attack but said it should remain on the market.
The FDA narrowly voted 8 to 7 to accept that advice, but in December 2009 an internal memorandum written by FDA Drug Centre director Dr Janet Woodcock said that there were “multiple conflicting opinions” about Avandia within the agency.
She has since scheduled a meeting for mid-2010 to reconsider whether the drug should be allowed to stay on the market.
A number of US politicians have raised the question as to why the FDA has allowed Avandia to remain on the market given the serious questions raised over its safety.
In a letter made public this week, a senior Republican lawmaker asked the FDA to confirm that an internal FDA group privately voted to keep the troubled diabetes drug Avandia on the market by a one-vote margin.
According to a bipartisan multi-year Senate investigation overseen by Senator Max Baucus and Senator Charles Grassley: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimise or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”
Baucus said: “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”
GSK have strongly rejected the conclusions given by the NYT and the report from the Senate investigation.
A spokeswoman said that: “Contrary to the assertions in the story, and consistent with FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events.”
“In the years since the FDA addressed these questions about the cardiovascular safety of rosiglitazone [Avandia], seven large, prospective, randomised clinical trials have reported results.
“None of these randomised clinical trials have shown a statistically significant association between rosiglitazone and myocardial infarction (heart attack) or other ischemic cardiovascular events.”
Nevertheless sales of Avandia continue to be badly affected and GSK’s recent fourth quarter financial figures showed a 48% drop in the US compared to the same period last year.
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