When is qnexa fda decision

I need something to help me lose weight. I feel so defeated. I never struggled to lose weight. Is this safe for me? Or can you recommend something that is? Jennifer — there are many safe FDA-approved medications for weight loss and for chronic weight management. First, review options for contraception with your doctor.

Your BMI calculates just over Anti-obesity medications are indicated if it is over 27 with a compelling comorbidity like high blood pressure, so Qsymia that is what Qnexa ended up getting named is not indicated. The weight gain is likely a result of quitting smoking, although the smoking is far more risky for your health than the weight. Several things come to mind, but I am not comfortable diagnosing or making treatment recommendations publicly — only privately for an established patient.

I hope this helps. Name required. E-mail required. Your Comment. Lazarus The FDA is again considering approval of an experimental weight loss drug it rejected a year ago over concerns about potential heart problems and birth defects in babies born to women who take the drug. Martin, MD. January 8, at am. Lazarus says:.

January 12, at am. Miranda Ricker says:. January 15, at am. Beverly Meador says:. July 3, at pm. July 6, at am. Jennifer Melbourne says:. August 21, at pm. Given that the submission was a major amendment to the marketing application, the FDA was permitted to extend its review period , changing the deadline to July A second weight-loss agent, lorcaserin Belviq , was approved on June 27, making it the first such drug to enter the anti-obesity market in more than a decade.

It, too, was approved for patients with a BMI of 30 or more, or 27 and up with at least one obesity-related comorbidity. Lorcaserin, made by Arena Pharmaceuticals, was also initially turned down by the FDA in , largely due to concerns about valvular heart disease. Arena was also asked to conduct postmarketing studies, including a long-term cardiovascular outcomes trial looking at major events such as MI and stroke.

FDA noted that patients on the combination agent who don't have effective weight loss by 12 weeks are unlikely to benefit, so therapeutic response should be evaluated by that time. We must act quickly to make our economy run on renewable power — and ensure that disadvantaged families and displaced workers share equitably in the new economy.

We also must fight the corrupting power of fossil fuel companies and ensure that energy regulators are effective and publicly accountable. Litigation can remedy or deter wrongdoing, impact policy and meaningfully slow abuses of power. Whether suing on behalf of our members to ensure the honest functioning of government, or representing individual consumers seeking redress in court, our litigation draws on our expertise in administrative law, constitutional law, and government transparency.

Statement of Dr. Note: The U. Food and Drug Administration late Tuesday approved Qnexa, a diet pill made by Vivus and renamed Qsymia, despite evidence that it poses significant risks but has little evidence of long-lasting weight loss. As was the case for the diet drug lorcaserin Belviq , approved last month despite concerns about heart valve damage, it also was reckless of the Food and Drug Administration to approve Qnexa. Research shows the medication increases heart rate, and four patients on the diet pill had non-fatal heart attacks during the clinical trials, while none of those on the placebo had heart attacks.

It is magical and delusional thinking for anyone to believe that a drug will turn off hunger without hitting other targets where it will do harm, usually to the cardiovascular system. Several previous diet drugs have been withdrawn from the market because they increased cardiovascular risk, including sibutramine Meridia because of evidence of an increased risk of heart attacks and strokes, fenfluramine and dexfenfluramine Redux because of heart-valve problems, and ephedra because of heart attacks and strokes.

Other serious problems identified in clinical trials with Qnexa, in addition to increased heart rate, a risk factor for cardiovascular disease, include:. Frequent metabolic acidosis — Although many people can compensate for this drug-induced adverse effect, in the clinical trials Qnexa caused increased nephrolithiasis kidney stones; 22 cases in the Qnexa groups, five in placebo ; uncompensated metabolic acidosis also is a risk factor for heart arrhythmias.