FDA Panel Rejects Diet Drug
An advisory panel to the Food and Drug Administration is urging the agency to keep the weight loss drug, lorcaserin, off the market.
Of the three diet drugs slated to be reviewed this year, lorcaserin has the least number of side effects. However, the panel still had some concerns over some “unanswered” safety questions. Additionally, the effectiveness of the drug could be described as minimal, at best.
In a clinical trial, roughly half of participants of the study lost 5% of their body weight – a requirement for the FDA to consider a diet drug “effective.” However, 25% of those who took a placebo had the same weight loss result. Summarily, those who took the drug lost only 3%-3.7% more body weight than those taking a placebo.
Despite the nominal weight loss, Arena Pharmaceuticals, manufacturer of the drug, maintains that any weight loss, no matter how slight, is beneficial to obese and overweight patients. However, the panel was concerned that the clinical trials did not include participants with diabetes or cardiovascular disease.
Abraham Thomas, MD, who served as panel chairman, is quoted by WebMD as saying the exclusion of patients with the type of health problems associated with obesity was “problematic.” He adds, “In the real world the achievable results are never as good as in the clinical trial. Dr. Thomas also chairs the department of endocrinology at Henry Ford Hospital in Detroit.
As for lorcaserin’s future, the FDA does not have to follow the advice of the panel, although they typically do.
2010 has been the year of the diet drug, as three separate ones were scheduled to be reviewed. The first one, Qnexa, was reviewed in July and was also rejected by the panel. Although the most effective of the three, Qnexa also had the highest drop-out rate because of the unpleasant side effects associated with it. Specifically, the panel was concerned about problems with concentration and dizziness.
Qnexa was actually derived from two other drugs working in tandem; phentermine, which also made up half of the diet drug Fen-phen. Qnexa also contained topiramate, an anticonvulsant.
In December, the panel will review the third and final diet drug, Contrave, manufactured by Orexigen Therapeutics.
Historically, diet drugs have gone down in a blaze of infamy; one of the most controversial of the genre was Fen-phen, which, according to the New England Journal of Medicine, increased the risk of pulmonary hypertension 23-fold.
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