FDA Should Reject Qnexa, Another Dangerous Diet Pill, Public Citizen Tells Advisory Committee
Feb. 22, 2012
FDA Should Reject Qnexa, Another Dangerous Diet Pill, Public Citizen Tells Advisory Committee
Qnexa Can Cause Serious Cardiovascular Problems, Should Not Be Approved
WASHINGTON, D.C. –The Food and Drug Administration (FDA) should not approve the proposed diet drug Qnexa because it can cause serious cardiovascular problems, Public Citizen said today in testimony to an FDA advisory committee.
Qnexa (a combination of phentermine, an amphetamine, and topiramate, an anti-seizure medication), 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.
The FDA rejected Qnexa, manufactured by Vivus, when it was first up for approval in 2010 because of concerns about the risk of birth defects, including cleft palate (due to the topiramate component) and about cardiovascular risks from phentermine. Public Citizen testified then that the drug should not be approved because these and other risks would be amplified by widespread off-label use. The manufacturer resubmitted data in support of its application, which is being weighed today 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 Dr. Sidney Wolfe, 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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Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.