Latest Weight Loss Drug Rejected by FDA
The latest hope for the overweight and obese looking for that magic bullet has been shot down in flames by the FDA when they rejected another new weight loss drug, Lorcaserin.
Higher than Normal Cancer Rate Detected
The FDA has contacted the makers of Lorcaserin to tell them it will not approve the marketing of the drug at this time. They cited concerns about its only marginal effectiveness but the real worry was over the higher than normal rates of cancers that occurred during the clinical trials.
This decision follows two weeks after a request by the FDA caused the makers of Meridia, a prescription diet pill, to pull it from both the US and Canadian markets.
The New England Journal of Medicine published the clinical trial of Lorcaserin, which found that a third of patients managed to lose at least 10 percent of their total body weight, while the other two thirds only managed to lose at least 5 percent. The average weight loss by patients was 17 to 18 pounds.
Lorcaserin was developed by a partnership of Arena Pharmaceuticals in San Diego and Eisai Co. The contents of an FDA letter in which the agency outlined its several concerns were released on Saturday.
Among those concerns were the results of weight lost by patients trialing the drug failing to rise to the FDA's approval standards. This was coupled with a worrying increase in the instances of cancerous breast and brain tumors found in rats. The test rats were given a higher dose of the drug than that which was proposed for humans.
In an attempt to address the concerns of the FDA, Arena Pharmaceuticals officials will be arranging to meet with the agency's officials.
A Warning to Other Drug Companies
This action is a terse warning to other drug companies who are developing weight loss pills with the intention to seek approval from the FDA. Another weight loss drug Contrave, is in line for consideration by the FDA in December.
Note: Some of the information included in this article was sourced from The LA Times.
A Warning to Consumers
This issue also brings with it a heady warning to overweight consumers that are seeking an easy way to lose weight without really making much of a serious change in their dieting habits and/or their exercising strategies, or lack thereof. If you're looking for a magic bullet pill to pop to make all the fat go away without doing anything else, the search will come up empty.
Drug companies are working hard to create just such a pill, because they know it will make them an absolute fortune if it works and gets approved by the FDA. However, in their rush to get at least something that might look like it might work onto the market, they appear to be ignoring the potential for side-effects that could potentially be more dangerous to health than being obese.
The best solution to being overweight is to take responsibility for your own health. Own up to your mistakes in eating and drinking unhealthy products and get tough enough with yourself to make the change to a healthier diet and lifestyle.
This is more important than many people seem to realize, as it can make the difference between enjoying a long, healthy and happy life or a short, unhealthy, painful and debilitating one. This is a free country and you have the freedom to choose. Make your choice a good one.
Weight Loss Pills Celerite Recalled by FDA
Latest Update (05 Feb 2011): The Food and Drug Administration have informed the distributors of the weight loss appetite suppressant capsules Celerite™ that it contains a potentially dangerous undeclared drug ingredient and must be removed from sale.
Shaping Beauty, Inc. are the company that distributes Celerite™ slimming capsules and the undeclared drug ingredient that the FDA lab have analyzed and found to be Sibutramine, which is used as a weight loss appetite suppressant.
This product has not been approved by the FD as drugs and therefore the safety of this particular product is not known. To that end, all lots of that dietary supplement product are now being recalled.
The product was being distributed and sold nationwide over the Internet at the website shapingbeauty.com so it has been advised to take down its advertising for that product.
FDA advises that this particular dietary supplement product could pose a threat to consumers. The drug Sibutramine has been discovered to substantially increase the blood pressure and in some cases the pulse rate in a percentage of users.
It therefore may present a significant health risk for any patients that have a history of congestive heart failure, coronary artery disease, arrhythmias or stroke.
If in doubt about any dietary supplements, always consult with a medical expert before taking.
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Posted on Mon, 25 Oct 2010 in News | 0 Comments