FDA clears first weight-loss pill in 13 years

Arena pharmaceutical’s anti obesity pill Belviq is the first to be approved by The Food and Drug Administration for a long time. Though the results were moderate during the trials, it has proved itself safe to be approved by FDA. It has been approved at a good time while doctors are waiting a new weight loss treatment.

The pill was cleared on Wednesday for adults who are obese and overweight along with one or more health problems such as high cholesterol or diabetes.

Though the FDA did not approve the drug in 2010 due to concern raised by the doctors about tumors that developed in animals during trials. The company again submitted early this year with all necessary data and FDA is convinced that there is very less risk of humans getting a tumor. The drug if used with doctor’s advice combined with healthy food and lifestyle, it will be a great option for the Americans who are obese. The drug is expected to launch in early 2013 by Arena and its partner Eisai Inc. of Woodcliff Lake, N.J.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments. But a long line of prescription  drugs for weight loss  have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. FDA never approved Phentermine and fenfluramine though they were recommended by doctors and were very popular for weight loss.

Even though the results maybe moderate with Belviq but it is a first step taken towards treating obesity. Belviq is one of three drugs that tried to get approval from FDA. Qnexa from Vivus Inc seemed to be more promising in weight loss during trials and FDA has postponed it s decision till July.

The patients taking Belviq had a moderate weight loss around 3 to 307 percent and people without diabetes showed loss of 5 percent. FDA has said that the patients who lose less than 5 percent after three months of taking the pills should stop them as there would be no further use holding on to the drug.

The likely side effects can be migraine, memory loss and depression. Xenical by Roche is the only drug in the market approved by FDA till Wednesday, though it was not prescribed extensively because of its side effects and now Belviq has been approved after 13 years since approval of Xenical.

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