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First FDA-Approved Weight Loss Drug in Nearly a Decade Hits the Market

After 13 years, a new weight loss drug has finally been approved for the market.  The FDA gave Arena Pharmaceuticals’ Belviq  the green light on June 27th.  Belviq (lorcaserin hydrochloride) is intended for overweight adults with a body mass index of 27 or higher and for obese adults with a body mass index of 30 or higher.

There have been other contenders in the weight loss drug market, but most have had life threatening side effects.  Accutrim and Meridia were pulled from the shelves due to strokes, and Fenfluramine was shown to have caused heart valve disease.

Like the withdrawn Fenfluramine, Belviq targets the serotonin 2c receptor of the brain that controls appetite.  However, unlike Belviq, Fenfluramine also activated the serotonin 2b receptor which caused heart valve damage to one out of three patients.

The clinical trials for Belviq tested around 8,000 overweight and obese patients with and without type 2 diabetes for 52 to 104 weeks.  All patients were on reduced calorie diets and received exercise counseling.  47% of patients without type 2 diabetes lost a minimum of 5% body weight while only 23% of the placebo experienced the same results.  For the type 2 diabetes patients, 38% of Belviq users lost a minimum of 5% body weight while only 16% of the placebo group had similar results.  Belviq also had a positive affect on glycemic control for the type 2 diabetes patients that lost weight.

While Belviq’s trial results are promising, there are still a number of side effects and concerns.  Belviq might cause serotonin syndrome, in addition to disturbances in memory and attention.  In 2010, the FDA noted that Belviq caused brain and breast tumors in rats when given 7 times the recommended dose.  Belviq should also be avoided during pregnancy.

Although there is currently no evidence that Belviq causes heart valve damage when the approved dose is taken, the FDA will require Arena Pharmeceuticals to conduct six postmarketing studies due to safety concerns.  One of these studies will focus on adverse cardiac events.