Potential Weight Loss Drug One Step Closer to FDA Approval, Despite Significant Safety Concerns

Friday, February 24, 2012

Written by Rayna E. Kessler, Esquire

Realizing the “blockbuster” potential, pharmaceutical companies are clamoring to bring new weight loss drugs to the U.S. market. To date, all of the potential contenders carry significant safety concerns that should be properly investigated before approval for use is granted.

In recent years, The Food and Drug Administration has already rejected three weight loss drugs, including Vivus’ pill Qnexa and Arena’s Lorcaserin. Qnexa is a combination of two older drugs, one of which is the same drug that was in Wyeth’s dangerous Fen-Phen. Qnexa was originally rejected in 2010 due to concerns that it caused “suicidal thoughts, heart palpitations, memory lapses and birth defects.” Now, Vivus has re-submitted the very same drug again for approval.

Persistence appears to be paying off for Vivus. This week, an FDA panel of outside physicians voted 20-2 in favor of approval for Qnexa. Although the vote is not binding, the FDA often follows the advice of its panel. Therefore, it is possible that Qnexa will achieve approval before the end of this year. So what’s changed this time around in the regulatory process? It doesn’t appear that Vivus has alleviated previously raised safety concerns. In fact, it remains unclear whether Vivus submitted any new data in support of its second try with regard to its cardiovascular or mental-health side effects. The Public Citizen testified before the FDA panel that the drug is not safe due to serious cardiovascular concerns. And yet, the panel overwhelming voted in favor of Vivus.

Some believe the FDA may be reacting to pressure from Congress to support new weight loss drug treatments. If this is true, the FDA should be reminded that the risks to public health with releasing a drug that effects the cardiovascular system of potentially millions of users should weigh equally in the drug approval process. The health of consumers depend on an impartial and effective pharmaceutical regulatory system.