Two new diet drugs have been approved by the FDA in a month. Qsymia and Belviq are the first two diet drugs to be approved since Roche’s Xenical in 1999. This comes as obesity rates in the U.S. top 35%.
The two drugs are approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia). Each drug was approved after conducting randomized, placebo-controlled trials which lasted over a year, all of which included reduced calorie diet and regular physical activity.
In the Qsymia trial, there were two dose regiments: recommended and high dose. For the recommended daily dose, the average weight loss was 6.7 lbs. in a year, and 62% of participants lost at least 5% of their body weight. For the high dose trial, the average weight loss was 8.9 lbs. over a year, and 69% of patients lost at least 5% of body weight. In the placebo control group, 20% of patients lost at least 5% of their body weight.
The Belviq trial involved 52-104 week treatments and also studied people with type 2 diabetes. The average weight loss for those without diabetes was 3-3.7% compared to the placebo, and 47% of patients lost at least 5% of body weight. This is compared to 23% of patients using the placebo losing at least 5% of body weight. For patients with diabetes, 38% of patients lost at least 5% of body weight, compared to 16% of diabetes patients on the placebo.
Diet drugs are not without side effects, as was discovered in 1997 when Fen-phen was found to damage heart valves. As a result, the FDA removed fenfluramine and dexfenfluramine from the market. However, the two new drugs, Qsymia and Belviq, are not associated with the same body functions and have not been found to cause similar damage. The new drugs do have other side effects, however.
Qsymia should not be taken during pregnancy because it can cause damage to the fetus, including cleft lip and cleft pallet. It should not be used in patients with glaucoma or hyperthyroidism. It increases the heart rate, so people with cardiac conditions, such as heart attack or stroke, should be monitored. The other side effects also include tingling of hands and feet, dizziness, altered taste sensation, insomnia, constipation and dry mouth.
Belviq should also not be used during pregnancy. It can cause serotonin syndrome, especially if taken with certain medicines that increase serotonin levels or activate receptors. It should be used with caution for those with congestive heart failure. The other side effects in those without diabetes include headache, dizziness, fatigue, nausea, dry mouth and constipation. Of those with diabetes, other side effects can include low blood sugar, headache, back pain, cough and fatigue.
Live Strong Statistics On Diet Pills Vs. Exercise: http://www.livestrong.com/article/489178-statistics-on-diet-pills-vs-exercise/
FDA Approves Weight-Management Drug Qsymia: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312468.htm
FDA Approves Belviq to Treat Some Overweight or Obese Adults: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htm
FDA Announces Withdrawal Fenfluramine and Dexfenfluramine (Fen-Phen): http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm179871.htm
Reuters Roche’s Diet Drug Tied to Kidney Damage: http://www.reuters.com/article/2011/04/12/us-health-kidney-idUSTRE73B7SZ20110412
The New York Times Prescription Drug to Aid Weight Loss Wins FDA Backing: http://www.nytimes.com/2012/06/28/health/diet-drug-gains-fda-endorsement.html
The Wall Street Journal Vivus Shares Drop Amid Report Questioning Diet Drug’s Prospects: http://online.wsj.com/article/BT-CO-20120719-717458.html