FDA approves 1st new weight loss pill in decade
BY EMILY MORRIS Staff Reporter June 27, 2012 12:28PM
(FILES)This July 2, 2009 image shows an overweight male. The US Food and Drug Administration on June 27, 2012 approved the first drug to treat obesity in 13 years, a drug called lorcaserin, marketed as Belviq and made by Arena Pharmaceuticals. "The US Food and Drug Administration today approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management," it said in a statement. AFP PHOTO/Karen BLEIERKAREN BLEIER/AFP/GettyImages
Would you try a prescription drug pill?
Updated: July 29, 2012 5:02PM
The Food and Drug Administration approved a weight loss drug for the first time in 13 years on Wednesday.
The prescription drug, when combined with changes in diet and exercise, is meant for obese and overweight individuals who suffer from a weight-related condition such as diabetes, high blood pressure or high cholesterol.
Belviq, generically called lorcaserin, works by activating a receptor in the brain that makes patients feel fuller after eating a smaller amount of food, the FDA said.
Dr. Bipan Chand, director of the Loyola Center for Metabolic Surgery and Bariatric Care at Loyola University Health System in Maywood, said he’s excited about Belviq’s potential to fight obesity.
“This is a new promising therapy that we can offer our patients,” Chand said.
But he concedes that the drug’s effects are limited, and it should be used to supplement a low-calorie diet and behavior therapy.
“The drug itself has modest effects in total body weight loss,” Chand said. “[But] it’s at least a win that we have another drug.”
The drug was studied in three trials with about 8,000 obese and overweight patients. On average patients lost just 3 to 3.7 percent of their starting body weight over a year. About 47 percent of patients without diabetes lost at least 5 percent of their weight or more, which was enough to meet FDA standards for effectiveness.
The FDA said patients should stop taking Belviq after three months if they fail to lose 5 percent of their body weight. Patients are unlikely to see any significant weight loss by staying with the drug.
Side effects with the drug include depression, migraine and memory lapses.
The FDA originally rejected the drug in 2010 when studies raised concerns about tumors that developed in animals studied with the drug. Later information supplied by Arena, the Switzerland pharmaceutical company that manufactures Belviq, alleviated fears and helped lead to the drug’s approval.
Since the FDA approved the weight-loss drug Xenical in 1999, others have not been approved. Xenical and others like it are relatively ineffective and come with some unpleasant digestive side effects, Chand said.
Some other drugs that have passed muster with the FDA have later manifested side effects that prompted their removal from market.
Meridia, manufactured by North Chicago-based Abbott Laboratories, was one such drug that the company withdrew in 2010 after studies showed it increased heart attack and stroke.
Another was the popular fen-phen combination, which was removed from the market in 1997 because of concerns that it damaged heart valves.
The FDA said Belviq should be used with caution for patients who suffer from congestive heart failure, and it has not yet been studied for patients with heart disease. But the agency maintains Belviq “does not appear to activate” the same receptors that caused the heart damage by other unsafe weight loss drugs.
While it might not cause heart damage, the way Belviq makes patients feel satisfied, by affecting the brain’s serotonin 2C receptor, is the very same mechanism that could harmfully affect patients’ mental states.
Chand cautions that doctors who prescribe Belviq should closely monitor their patients for signs of depression, a possible side effect of the new drug.
The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth, and constipation, and in diabetic patients are low blood sugar (hypoglycemia), headache, back pain, cough, and fatigue, according to the FDA.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.