For the first time in thirteen years, the Federal Food and Drug Administration (FDA), has approved a weight-loss pill. Belviq, which also goes by the generic name of lorcaserin, was given a FDA nod despite concerns about safety issues. The "diet pill" is to be taken in conjunction with a reduced calorie diet and a program of exercise.
The drug works by activating a receptor in the brain that suppresses appetite by causing a person to eat less but feel full after doing so.
Who Can Take Lorcaserin?
Lorcaserin has been approved for use by obese adults with a body mass index (BMI) of 30 or more or overweight adults with a BMI of 27 or more if they have a co-morbidity of high blood pressure, type 2 diabetes, or high cholesterol.
The drug was tested in placebo-controlled clinical trials including subjects with and without type 2 diabetes. The treatment extended from 52 to 104 weeks. Patients treated with lorcaserin lost an average of 3 to 3.7 percent of their body weight in a period of up to one-year.
Translated, this means a woman who is 5' 6" tall and weighs 190 with a BMI of 30 can expect to lose six pounds.
Those patients with diabetes lost at least five percent of their body weight.
It is recommended the drug be discontinued for patients who fail to lose five percent of their body weight after twelve weeks of treatment.
FDA Approval of Lorcaserin
A panel of expert advisors recommended that the FDA approve sales of lorcaserin despite concerns about heart risks, tumor growth, and initial rejection for market.
The panel approved public sale of lorcaserin by a vote of 18-4 with one abstention citing the belief that the benefits outweighed the risks.
Side Effects of Lorcaserin
The gravity of the side effects of lorcaserin are worth noting.
Lorcaserin has caused tumors in rats and caused heart valve damage.
Lorcaserin has had an effect on the serotonin receptor, the origin of the heart problems associated with phen/fen.
The consumer group, Public Citizen, has expressed concerns about lorcaserin, noting that the benefits of the drug are minimal in that not much weight is lost. The consumer group also points out that that there is not enough evidence to rule out clinically meaningful heart valve disease.
An additional concern is that a large number of obese patients who are already at risk for cardiovascular disease will face the additional risk of damaged heart valves.
The FDA cautions that the drug should be taken with caution by those people who have congestive heart failure. The medication should not be used by pregnant women and it can also cause disturbances in attention and memory.
The manufacturer of lorcaserin is required to do six post-market studies including a long-term cardiovascular trial.
It seems there are more stumbling blocks in the road ahead to find a significantly effective weight-loss drug with a low side effect profile.
CBS News http://www.cbsnews.com/8301-504763_162-57432777-10391704/panel-advises-fda-to-approve-lorcaserin-obesity-pill/ - accessed 6/29/12
News Inferno http://www.newsinferno.com/pharmaceuticals/some-question-fda-panels-approval-nod-for-new-weight-loss-drug/37719 - accessed 6/29/12
USA Today http://www.usatoday.com/news/health/story/2012-06-27/new-prescription-diet-drug/55862276/1 - accessed 6/29/12
Vitals on MSNBC.com http://vitals.msnbc.msn.com/_news/2012/06/27/12440533-fda-oks-first-new-weight-loss-pill-in-13-years?lite - accessed on 6/29/12
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Published On: June 30, 2012