FDA Panel on Lorcaserin: Health Risks Outweigh Potential Benefits
The FDA Endocrinologic and Metabolic Drugs Advisory Committee is having a busy year. Multiple weight loss drugs have been up for approval or have been reviewed due to safety concerns. Yesterday the panel advised against recommending Arena Pharmaceuticals’ new obesity drug lorcaserin, brand name Lorqess.
Earlier this week the panel was split on recommending for or against the withdrawal of a currently approved weight loss medication: Meridia. The panel also recommended against the approval of Qnexa in July.
Lorcaserin Concerns Include Depression and Memory Loss
The FDA Committee voted 9 to 5 against recommending lorcaserin because the side effects were thought to outweigh the potential benefits. In clinical trials, average weight loss was only about 3 to 5% of body weight, and side effects include depression and memory loss.
There is also a new concern – animal studies on lorcaserin showed an increased incidence of cancerous tumors. A study of laboratory rats found a seven fold increase in mammary (breast) tumors in those given the high doses of the drug. There was no increase in cancer found in any of the human trials.
Lorcaserin works by stimulating serotonin receptors in the brain, which causes feelings of satiety or fullness so that the patient eats fewer calories. In addition to weight loss, the patients also experienced improvements to cardiovascular risk factors such as heart rate, blood pressure, and total and LDL cholesterol levels.
In its drug application, Arena Pharmaceuticals submitted 18 clinical trials involving over 8,500 patients. One concern of panel chair Dr. Abraham Thomas was that the studies excluded patients with diabetes and cardiovascular disease, two groups that likely comprise a large portion of those who would be prescribed the drug.
The decision now goes before the US Food and Drug Administration, which will rule in October on the ultimate fate of lorcaserin. Arena Pharmaceuticals has issued a statement that the company will work closely with the FDA through the process. They have initiated a study of the drug in 600 diabetic patients and are “eagerly awaiting the results”.
The History of Lorcaserin:
Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial
Arena's Obesity Drug Lorcaserin Passes Safety Review
Arena Pharmaceuticals Submits Application on New Weight Loss Drug
Three New Weight Loss Drugs Up for FDA Approval