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FDA panel recommends heart studies for prospective obesity drugs

Filed April 2nd, 2012 Laurie

An advisory panel to the Food and Drug Administration has recommended the agency require heart safety testing on any new obesity drugs it is considering for approval.

According to a report from Reuters, the panel voted last week by an overwhelming majority to recommend to the FDA that it require these pre-market tests for new obesity drugs, even if data being submitted for the drug does not indicate any such risk.

The panel believes the previous risks posed by obesity drugs to the heart combined with new evidence mandates these tests be conducted before an unknowing public is exposed to these risks without having access to as much safety data as possible.

The FDA will likely vote on this recommendation in the coming week or two after it has had time to review the information included by its panel of physicians and drug industry experts.

The move mostly centers around the impending approval decision the FDA must make on Qnexa, a prospective new drug that’s targeted to treat obesity. If the FDA does heed the recommendation of its panel it would be in line with a recent order it gave to the makers of the weight loss drug Contrave, requiring its maker Orexigen Therapeutics to conduct post-market heart safety tests on the drug.

One panel member told Reuters the “bad track record” of obesity drugs led to the 17-6 vote. The FDA has not approved an anti-obesity or weight loss prescription drug in more than a decade and those which made it to the market have shown they pose serious heart health risks to patients.

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