Galveston drug injury attorneys update their previous posting on the Qnexa approval debate. In a surprisingly one-sided 20 to 2 vote, an FDA advisory panel composed of medical professionals has reversed its previous rejection of the weight loss drug Qnexa due to safety concerns. The FDA panel contained 12 members from that earlier vote of rejection. 7 of those 12 had earlier voted against recommending approval of the diet drug Qnexa. 20 members of the current FDA advisory panel recommended FDA approval of Qnexa.
The FDA does not make its final decision on Qnexa’s application for admission to the U.S. marketplace until April. But our Galveston drug injury attorneys point out that the FDA usually follows the recommendations of its advisory panel. However, in 2011, the FDA significantly rejected another weight loss drug that had been recommended by its advisory panel. If the FDA follows the panel’s recommendation and approves Qnexa, Qnexa will be the first prescription weight loss drug the FDA has approved for the U.S. market since 1999.
Panel members and others interviewed for news reports about the panel’s recommendation seem to have based their approval primarily on the perceived need for more weight loss tools to address the obesity epidemic. It appears to our Galveston drug injury attorneys that the decision chooses to address the existing health risks from obesity at the expense of the potential health risks of the drug. Clinical trials of Qnexa showed heightened heart risks. In addition, women taking the drug experience a 2 to 5 times greater risk of producing babies with birth defects (primarily cleft lip and/or cleft palate).
The assurances of Vivus, Qnexa’s manufacturer, that it will conduct strict oversight regarding prescribing and use of the drug seems to have been sufficient to allay almost all panel members’ safety concerns. But at least one panel member was not hesitant to speak out about the drug’s dangers after voting “no.”
Dr. Michael S. Lauer, a cardiologist from the National Heart, Lung, and Blood Institute, cautioned strongly that the increased heart rate revealed in clinical trials of Qnexa is a warning sign of cardiac problems and could heighten the risk of heart attack in spite of the drug’s benefits. He stressed that other medical decisions taken on the basis of insufficient, but seemingly clear, evidence have later proven to be wrong at the cost of patients’ lives and health.
Vivus has said that it will take important steps to ensure the drug’s safe use, including:
Our Galveston drug injury attorneys emphasize that obesity is indeed a pressing health concern. About 36% of Americans are obese, with another 33% of Americans overweight. Approximately 5% of the nation’s population is morbidly obese. Obesity has been clearly shown to lead to diabetes and heart disease. Obesity is also thought to be a strong risk factor for osteoarthritis, dementia, stroke, and certain types of cancers.
But combating obesity and its related health problems with a drug that causes other health problems might not be the answer. The FDA panel recommended that Vivus conduct follow-up studies on the heart health of patients who receive the drug. If Qnexa does receive FDA approval, the expected widespread use of the drug should quickly show whether the panel’s balancing of health risks and benefits represented a correct choice. If they were wrong, sadly the data will come at the expense of patients’ lives and health.
For more information on Qnexa and its potential side effects, see our Galveston drug injury attorneys’ previous article discussing the Qnexa safety issue.