FDA Approves Another Diet Pill; Qysmia

On Tuesday, the Food and Drug Administration approved yet another weight loss drug. Next to Belviq, makes the second diet drug within in the last month. Previously the agency had not approved a new drug for long-term weight loss since 1999.  Many doctors consider Qsymia, manufactured by  Vivus, the most effective therapy in a new generation of anti-obesity pills designed to help patients safely lose weight.

The agency cleared the pill Qsymia for adults who are obese or overweight and have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol.

Studies show that patients taking Qsymia for a year lost 7 to 9 percent of their body weight. That was more than two other weight loss pill recently reviewed by the FDA. The medication is actually a combination of two older drugs that have long been known to help with weight loss: phentermine and topirimate.

Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss. Topiramate is an anticonvulsant, sold by Johnson & Johnson as Topamax, that makes people feel more satiated after eating. These medications can be acquired by prescription written by your doctor or a specialist.

Researchers say the innovation of Qsymia lies in targeting multiple brain signals that drive people to overeat.

Many doctors may have called on the FDA to approve new weight loss treatments because the obesity rate in the U.S. is rapidly growing. As of this writing, nearly 35 percent of the American population is considered obese.  The FDA’s successive approval of Qsymia and Belviq suggests a new desire to make weight loss medications available.

The FDA initially rejected Vivus’ drug in 2010 over concerns that it can cause birth defects if taken by pregnant women. The agency laid out a risk-management plan Tuesday specifically designed to minimize the chance of the women becoming pregnant while using the drug. It recommends that women of childbearing age test negative for pregnancy before starting the drug and take a monthly pregnancy test while taking it.

The agency also said patients with recent or unstable heart disease or stroke may not be ideal candidates for the drug because its effect on heart rates in those patients is not known. The FDA stated that Vivus has to do studies of the heart effects of Qsymia.

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