The U.S. Food and Drug Administration has approved the weight loss drug Qsymia, which went through trials as Qnexa. Dr. Oz made it popular before the approval even came, with an episode about the “the silver bullet” diet pill this spring. It’s the second diet drug to be approved by the FDA in 13 years, and the second this summer, following last month’s Lorcaserin approval. It will be the most potent weight loss drug on the market.
The drug was approved by an FDA Advisory Panel by a landslide vote of 20-2 in February, and yesterday the agency announced its final approval of Qsymia. The drug was approved for adults with a (BMI) of 30 or greater, which is categorized as obese, or adults with a BMI of 27 or greater, categorized as overweight, who have at least one obesity-related disease like high blood pressure/hypertension, type 2 diabetes, or high cholesterol.
Vivus, the creators of Qsymia, claim that just one pill a day will suppress the appetite and help obese individuals lose 10 percent of their body weight. The pill is comprised of two drugs that were already on the market in various weight loss drugs – one of which is phentermine, a type of amphetamine that stimulates the nervous system and increases heart rate and blood pressure. It’s used in weight loss drugs to suppress appetite, and is more commonly recognized as the “Phen” in the weight loss drug Fen-Phen, which was yanked from shelves by the FDA in 1997 after being deemed too dangerous for consumption. The other drug is an anti-seizure medication that helps stimulate weight loss.
There’s been great concern surrounding Qnexa’s side effects, which include increased heart rate, heart palpitations, kidney stones, memory loss and birth defects. DietsInReview.com’s resident pharmacist Dr. Sarah G. Khan weighs in with her concern over the drug’s approval.
“I can’t say I’m surprised by the approval of Qsymia with obesity rates at an all time high. My biggest concerns would be how doctors will counsel their patients after they prescribe the medication. Will they refer them to a nutritionist or exercise program? To maximize the effects of Belviq and Qsymia, diet and exercise are essential to promote weight loss and change habits to prevent relapse weight gain,” she said. “With my own personal weight struggle I would never promote drugs or procedures over less invasive and potentially less dangerous measures.
“Permanent weight loss takes time and replacing unhealthy habits with better ones is a process,” said Khan. “I wish anyone luck who is willing to try these medications, but I think getting to the root of the problem of why we eat so much and with so little nutritional value, or why we don’t make time to exercise, is what we should be focusing on. This is a similar situation to how we treat mood disorders with medication and not enough behaviorial counseling.”
The FDA was concerned in the past with Qsymia’s side effects, but when the committee reassessed the drug again this year and compared the side effects of the drug to the side effects of obesity, the side effects of obesity were considered more dangerous.
“Obesity threatens the overall well being of patients and is a major public health concern,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research in a release by the FDA. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
Seventeen percent of children and one-third of all adults in the U.S are obese. With this drug’s approval, experts estimate that 72 million people could be helped. However, previous concerns about the drug are still present and when the pill does go on shelves, consumers should be aware of the severity of the drug’s side effects.
July 18th, 2012