FDA raises safety concerns for Qnexa diet pill

By Dow Jones

February 17, 2012

WASHINGTON -- The Food and Drug Administration raised concerns about possible long-term side effects of Vivus Inc.'s diet pill Qnexa in a review posted on its website Friday.

The documents posted in advance of an advisory panel meeting on Wednesday, cited concerns about potential side effects of the drug such as birth defects and an unknown impact on the heart, but said Qnexa was effective at helping people lose weight.

The pill is being reviewed by the FDA for a second time after previously being rejected by the agency in 2010. The review of the drug includes two-year clinical data rather than one year's worth of data that was reviewed in 2010.

Qnexa will face the agency's endocrinologic and metabolic drugs advisory committee, which is made up of non-FDA medical experts.

The panel is being asked to vote on and discuss a series of questions including whether the "overall benefit-risk assessment" supports approval of Qnexa.

The FDA usually follows the advice of its panels but is not required to.

In 2010 the FDA rejected Qnexa and asked Vivus for an assessment of the drug's potential to cause birth defects and for evidence that the product does not increase the risk for major adverse cardiovascular events.

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FDA raises safety concerns for Qnexa diet pill