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FDA disapproved the new weight loss drug Lorcaserin because of the insufficient evidence and information about the drug’s safety and efficacy.

In a letter submitted by the FDA to Lorcaserin’s manufacturer, Arena Pharmaceuticals, the FDA questioned how the breast tumor findings in laboratory rats who received lorcaserin relate to the action of this weight loss drug to human subjects.  Furthermore, FDA also commented that the weight loss benefit of Lorcaserin in nondiabetic, obese subjects is only marginal, thus they have requested the final results of the BLOOM-DM study, the study that claims to show the full efficacy and safety of this obesity drug.

In the latest results of the BLOOM-DM trial it has been shown that patients who are treated with Lorcaserin usually have an average weight loss of five to six kilograms. However, the potential cancer development and the unimpressive weight loss effect of this drug still preoccupy the minds of those belonging to the advisory group of the FDA.

According to Heartwire, this impending negative decision of the FDA is a hard blow to those waiting for the grand entrance of a new prescribed weight loss medication that can take the place of Sibutramine in the weight reduction world.  It also mentioned that more and more patients are now willing to accept any minor risks if this new obesity drug can really help them lose those unwanted pounds off their weighing scale.

Category : News

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