October 23, 2010 |
The FDA has told the makers of the proposed weight-loss drug Lorcaserin that it will not at this time approve marketing of the medication, citing concerns about its marginal effectiveness and about cancers that occurred at higher-than-usual rates during clinical trials. The decision comes two weeks after the makers of the prescription diet pill Meridia pulled it from the U.S. and Canadian markets at the request of the FDA. The action on Lorcaserin is the first signal of how the U.S. drug agency will deliberate on a trio of new weight-loss drugs proposed for the U.S. market, where about one in three adults are obese.
September 16, 2010
This is not shaping up to be a good year for people seeking medical help for weight loss. A Food and Drug Administration advisory committee on Thursday voted against recommending approval of the drug lorcaserin. This is the third negative vote on prescription obesity drugs this year by the advisory committee. The committee voted, 9 to 5, agaianst recommending approval because the risks of the drugs outweighed the potential benefit of modest weight loss. Studies in animals showed the drug was associated with tumors, although an increased cancer risk has not been seen in human clinical trials.
September 14, 2010
The Food and Drug Administration released information Tuesday suggesting it's unimpressed by a weight-loss medication under development by Arena Pharmaceuticals Inc. and casting doubt on the drug's eventual approval. An FDA advisory committee is scheduled to meet Thursday and vote on whether to recommend approval of the drug, lorcaserin. But in documents released Tuesday in advance of the meeting, the FDA noted that studies on lorcaserin showed the average weight loss while taking the drug was not significantly different than the average weight loss among people taking a placebo.
July 14, 2010 |
The recent history of medications to help people lose weight isn't pretty. Several drugs have been removed from the market for safety problems. And, more recently, some medications in late-stage clinical trials were shelved because of safety problems. The Food and Drug Administration is evaluating the risks and benefits of a drug that is already on the market, sibutramine (Meridia), because of evidence that it might be unsafe for some people with heart disease. Only one other prescription drug, orlistat (Xenical)
July 17, 2012 |
For the second time in a month, the Food and Drug Administration has approved a prescription weight-loss medication for the nation's 78 million obese adults after maintaining for years that the measly benefits of the pills did not outweigh their significant costs. Qsymia, a combination of two drugs already approved to treat other conditions, "provides another option for the chronic weight management of Americans" who are obese or who are overweight and suffer a related condition such as Type 2 diabetes, high blood pressure or worrisome cholesterol readings, said Dr. Janet Woodcock, the FDA's chief of drug evaluation, on Tuesday.
April 11, 2011 |
The diet drug Qnexa helps obese people with weight-related medical conditions to lose more weight than those who take a dummy pill and could allow some to scale back on medications for diabetes, high blood pressure or cholesterol, according to a new study published online in the Lancet . Only this study is not so new -- and its findings may be less weighty than might be concluded with its publication in this respected medical journal....