The second obesity drug in a month was given approval by the Food and Drug Administration. Qsymia follows Belviq as another weight-loss medication doctors can put in their arsenal to help patients fight the battle of the bulge.
Qsymia, formerly known as Qnexa, is a combination of topiramate (a seizure medication that has an effect on appetite) and phentermine (an appetite suppressant used for short periods). The drug has been approved for adults who have a body mass index of 30 or higher (considered obese), or for those who have a BMI of 27 or higher as well as another condition linked to being overweight, such as high blood pressure or Type 2 diabetes.
The drug earned an FDA recommendation in February in a 20 to 2 vote. But the panel originally rejected the drug in 2010 over side effect concerns. Although in two clinical trials participants lost between 6.7 percent and 8.9 percent of their body weight, trials also showed an increase in the risk of oral cleft birth defects when pregnant women used the drug.
Another side effect was a slight rise in heart rate, which could up the risk of stroke or heart attack. An FDA statement on the drug’s approval said manufacturer Vivus, Inc., must conduct a long-term study looking at cardiovascular effects to see if Qsymia has any impact on the odds of heart attack and stroke.
The statement also specified that the drug must not be used during pregnancy “because it can cause harm to a fetus,” referring to the oral cleft risk.
“Obesity threatens the overall well being of patients and is a major public health concern,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. “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.”
Several weeks ago the FDA OK’d Belviq (known as lorcaserin), the first weight-loss drug to get approval in 13 years. The medication was also turned down by the FDA in 2010 over concerns about slight weight-loss outcomes and tumors that developed in rats.
“By approving another medication that will help healthcare professionals treat this disease more effectively, the FDA continues to show us that they are treating obesity seriously,” Dr. Patrick O’Neil, president of The Obesity Society, said in a news release. “Since obesity can arise from many causes, no single medication will work for everyone. This is a great step in the right direction, but, we must maintain our focus of developing even more treatments that are safe, effective, and accessible.”
What part should medications play in weight loss? Let us know in the comments.
Jeannine Stein, a California native, wrote about health for the Los Angeles Times. In her pursuit of a healthy lifestyle she has taken countless fitness classes, hiked in Nepal, and has gotten in a boxing ring. Email Jeannine | TakePart.com
- Disease & Medical Conditions
- Food and Drug Administration