FDA should reject Qnexa, another dangerous diet pill, consumer groups says
February 27, 2012
The diet drug Qnexa shouldn’t be approve because it can cause serious cardiovascular problems, Public Citizen, a consumer advocacy group, told a U.S. Food and Drug Administration advisory committee.
An anti-seizure medication, Qnexa – a combination of phentermine, an amphetamine, and topiramate – causes increased heart rate and may lead to severe cardiovascular problems, such as heart attacks and arrhythmias, as well as birth defects, kidney stones, decreased bone mineral density, and memory impairment, Public Citizen said in a statement.
The FDA rejected Qnexa, manufactured by Vivus, when it was first being considered by the FDA for approval in 2010 because of concerns about the risk of birth defects, including cleft palate from the topiramate component and cardiovascular risks from phentermine.
Public Citizen testified then that the drug shouldn’t be approved because these and other risks would be increased by off-label use. The manufacturer resubmitted data in support of its application, which is being evaluated by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.
“Public health cannot tolerate yet another drug approval for a diet drug not accurately assessed for cardiovascular risks, especially in light of suggestive findings of such risks with Qnexa,” said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group. “The danger of another approved diet drug hitting something vital – the cardiovascular system – is no longer acceptable when it could be prevented by a large clinical trial powered to evaluate such risk prior to approval.”
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