FDA Approves Weight Loss Drug

Lorcaserin just won their approval from the United States Food and Drug Administration (FDA); this clears the way for marketing and sales in the United States. Lorcaserin had to push hard for this approval because the FDA and the pharmaceutical companies were still living down their past fiascos relative to weight lost drugs.

Lorcaserin appears to offer would-be dieters modest benefits at best. One clinical trial found that two-thirds of patients on the drug lost 5 percent of their body weight; while one-third lost at least 10 percent. At the end of one year of taking the drug as a supplement to diet and exercise the Subjects in the clinical trial lost an average of 17.5 pounds.         

The FDA’s approval came with a significant warning to consumers likely to flock to a medication that could help boost their weight loss: The safety and effectiveness of Belviq when used alongside other diet medications has not been established. Nor, the FDA said, has the effect of Belviq been proven as safe relative to the long-term risk of having, or dying from, a heart attack or stroke.

Lorcaserin is the first prescription anti-obesity medication to win the FDA’s blessing since the agency approved Orlistat in 1999.   Lorcaserin will be marketed under the brand name of Belviq which is made by San Diego based Arena Pharmaceuticals. It is one of four weight-loss drugs the FDA has anguished over in recent years. Safety concerns have prompted the agency to order the makers of two other candidate drugs to conduct and comb through additional research. A third drug was withdrawn after it was linked to an elevated suicide risk.

In the 28 months since the makers of Belviq submitted the drug for FDA consideration, the agency also demanded the withdrawal of Meridia after studies showed it increased the risk of heart attack and stroke. That left only two FDA-approved weight-loss drugs on the market: Orlistat and Phentermine.

The affirmative vote surprised many in the industry who saw it as a desperate response to help Americans lose weight.  1 in 3 adult Americans are considered obese, and an additional 36 percent are overweight.  This has led to widespread concern regarding type 2 diabetes, heart disease and certain cancers that have been closely linked to obesity.  Many government officials are highly concerned that U.S. health care system will be overwhelmed by rapidly growing obesity-related diseases that are estimated to exceed $147 billion in annual health care costs.

Many healthcare insiders are not huge fans of Qnexa, and many are vehemently opposed to Lorcaserin. While Qnexa is worrisome (potentially intoxicating side effects), Lorcaserin is absolutely frightening.

How Lorcaserin Works

Lorcaserin Works on the Brain’s Serotonin System
Serotonin is a neurotransmitter; this “chemical messenger” helps the communication process between your neurons. Lorcaserin affects your brains serotonin systems. In this regard, Lorcaserin is like many of the commonly prescribed anti-depressant medications called “selective serotonin re-uptake inhibitors.”  However, you should be aware that there is a crucial difference between Lorcaserin and drugs like Prozac and Zoloft.

Lorcaserin is a Serotonin Agonist
Lorcaserin binds to and directly activates serotonin receptors. SSRI’s like Prozac do not directly activate serotonin receptors. They are, “reuptake inhibitors” that actually prolong the effect of naturally produced serotonin. Lorcaserin, on the other hand, works in a different manner; it does not prolong the reuptake of naturally produced serotonin, instead it mimics serotonin binding directly to the serotonin receptors. The downside this is that it actually overpowers, displaces, and prevents naturally occurring serotonin from affecting the same receptors. In essence it removes an essential process that naturally occurs in your body; generally this is never a good idea.

Remember Fen-Phen? It also contained a Serotonin Agonist called Fenfluramine.
Fen-Phen was a disastrous diet drug combination from the 90’s. Fenfluramine was a serotonin agonist that suppressed appetite; however, it also caused cardiac fibrosis which damaged the lining of the heart along with the lining of the delicate heart valves. The problem stems from the fact that both the lining of the heart and its valves contain serotonin receptors. Fenfluramine attached to those receptors, and actually over-powered them, causing the delicate cells to self-destruct. This cumulative damage ultimately led to the thickening and scarring of the delicate lining of the heart and the heart valves. It was a problem than, and many believe it will become a problem again!

As a whole, Serotonin Agonist’s have a history of cardiac fibrosis! (heart and heart valve damage)
Fenfluramine, Chlorphentermine, Pergolide, and Cabergoline were drugs that acted as serotonin agonists. Every one of these drugs were withdrawn from the market because they were linked to cardiac fibrosis. Unfortunately, many healthcare professionals believe that Lorcaserin will simply expand the list of deadly drugs that have somehow won the FDA’s approval.

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