Physician: FDA should not approve weight-loss drug without being certain of safety

In a column for USA Today, Marc Siegel, MD, professor of medicine at the NYU Langone Medical Center, writes about concerns over the safety of Qnexa [phentermine/topiramate], a new obesity drug that has been recommended for approval by the Food and Drug Administration.

Siegel expresses concern over prior studies showing that “topiramate doubles the risk of cleft lip and palate in newborns of mothers who were taking the drug.”

In addition, it “can cause cognitive slowing, problems with memory and decision-making, and fatigue.”

Although “Qnexa’s manufacturer, Vivus” has reassured the FDA “that it will restrict the drug for pregnant women and perform studies after approval to assess heart safety,” Siegel argues that “the FDA shouldn’t be pressured into prematurely approving Qnexa without first being absolutely certain about its safety.”

I think I have to agree.

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