FDA Advisory Committee votes 22-1 for GSK's diabetes drug to continue to be marketed in the US
The US Food and Drug Administration’s (FDA’s) Advisory Committee came to an almost unanimous decision yesterday, voting 22-1 for Avandia, GlaxoSmithKline’s much-maligned diabetes treatment, to remain on the US market.
Concern about side effects associated with Avandia (rosiglitazone) was raised by a meta-analysis published in the New England Journal of Medicine in May. The analysis, led by Steven Nissen of the Cleveland Clinic, Ohio, US, concluded that the drug increased the risk of heart attack and death (see Chemistry World July 2007, p16).
The committee convened to evaluate all of the post-approval clinical data and assess the ’overall risk-benefit profile’ of the drug.
During a press conference following the meeting, the acting committee chair, Clifford Rosen from the Maine Center for Osteoporosis, Bangor, US, highlighted a ’significant number of caveats’ for the prescription of Avandia.
’I think there are clear-cut reasons not to use this drug in certain types of diabetes patients,’ he said. ’These include those with or prone to congestive heart failure and people with significant risk of cardiovascular disease.’
The FDA will now consider the panel’s recommendations and make its final decision about what action to take. This could include the addition of appropriate warning labels on the drug’s packaging and the provision of advice to prescribing doctors.
GSK welcomed the committee’s decision to ’support the continued availability’ of Avandia to patients in the US and said that it would it will continue to provide information to the FDA to assist in the Agency’s final decision-making. A spokesperson for the FDA told Chemistry World that although the agency is not obligated to follow the recommendation of the committee, it is rare that it goes against its advice.
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