Archive for November 16th, 2010

Obesity Drug Woes Continue

November 16th, 2010 | No Comments | Source: MedPageToday, Washington Post

Amid the burgeoning worldwide epidemic of obesity, scientists and pharmaceutical companies have spent hundreds of millions of dollars to develop drugs to help people lose weight. The effort has failed spectacularly so far, and 2 recent setbacks have fueled increasing pessimism that things will change for the better anytime soon. 

The first setback occurred last month when the FDA put the kibosh on Arena Pharmaceuticals’ New Drug Application for lorcaserin, an investigational weight loss drug. In rejecting the application, the FDA  cited several concerns including low efficacy and the results of animal studies which suggested that it increased the risk of breast cancer.

In its letter to the San Diego-based drug company, the FDA said “the weight loss efficacy of lorcaserin in overweight and obese individuals without type 2 diabetes is marginal.” The letter also said the regulatory agency needed more information from a study that is now underway before considering the matter further, and that if Arena could not provide data to “alleviate concern regarding clinical relevance of the tumor findings in rats, additional clinical studies may be required to obtain a more robust assessment of lorcaserin’s benefit-risk profile.”

The FDA’s snub of lorcaserin was followed in short order by an announcement by Abbott Laboratories that it was withdrawing the diet drug Meridia from the market. Abbott’s decision was prompted by FDA findings that showed the drug’s limited efficacy was outweighed by significant risks associated with the drug.

Meridia had long-since been known to increase blood pressure, but the death knell came in the form of a European study which showed it was associated with a 16% increased risk of cardiovascular problems including heart attacks, strokes and death.

Nearly 100,000 Americans take Meridia at the moment. The FDA advised all of them to stop taking the drug, and instructed physicians to stop prescribing it. European regulators had taken Meridia off the market in January.

“It’s been very frustrating,” Jennifer Lovejoy, the incoming president of the Obesity Society told the Washington Post. “We desperately need safe new drugs so we can begin to have something effective against this public health epidemic.”

Meanwhile, experts continue to emphasize that the best way to stay healthy is to avoid gaining weight in the first place by eating well and exercising regularly…


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