The newest drug is meant to be taken by patients with a body mass index of 30 or greater, and overweight adults, those with BMI of 27 or greater, who have at least one weight-related condition such as high-blood pressure, type 2 diabetes or high cholesterol.
The FDA took its time in reviewing Qsymia because of fears about the side-effects, which can include a fast heart rate and metabolic acidosis, a condition marked by highly acidic blood that can, in severe cases, put people into a coma and even kill them. Metabolic acidosis can also cause kidney stones and damage bones. There’s been a growing debate over whether it’s worth the risk of taking drugs that could damage the heart to battle the growing obesity epidemic.
We are all aware of the disastrous past with diet pill users. And, the FDA is still uncertain if these pills will fall into the wrong hands. Yet they still approved the drug.
But, Vivus, the company that makes the drug, has said it’s aware of the concern and distrust of the public and has said it would restrict who can prescribe Qsymia and how. The once-a-day pill will be available only through mail order so that doctors cannot dispense it from their offices. The company also plans to educate doctors about the drug’s risks, which include birth defects, and to carefully watch users for any signs of heart damage.
But, why the last minute name change?
The agency asked for a last-minute name change from Qnexa, because “The FDA indicated concern about potential confusion regarding the name Qnexa and worked with Vivus during the final steps of the review process to identify Qsymia as an acceptable brand name,” Vivus’s Dr. Barbara Troupin said in a statement.
Some are still not on board with the whole idea, and have concerns and fears as to who will be taking these pills, and the adverse side effects that are known to be involved.
Dr. Michael Lauer, a cardiologist at the National Institutes of Health who was on the panel of experts that advised the FDA about the drug voted against approval, but 20 panelists endorsed the drug in February.
“I believe that if the public were to ‘buy’ (Qsymia) after FDA approval, it would run the risk of severe, even fatal, consequences from another diet lemon,” Lauer wrote in an issue of the Annals of Internal Medicine.
“If we think about the history of obesity medications, we’ve seen plenty of lemons. Ephedra, fen-phen, phenylpropanolamine, and sibutramine had to be withdrawn from the market because of cardiovascular toxicity. Rimonabant was approved for sale in Europe, but was never approved in the United States because of severe psychiatric side effects,” he added.
Lauer is not the only opponent. Public Citizen, a consumer group, has been campaigning against the drug, too.
“As was the case for the diet drug lorcaserin (Belviq), approved last month despite concerns about heart valve damage, it was also 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,” Public Citizen’s Dr. Sidney Wolfe said in a statement.
“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.”