FDA says NO to diet pill Lorcaserin

 

The Food and Drug Administration's panel of experts voted 9-5 against Arena Pharmaceuticals' diet drug Lorcaserin. They said unresolved safety questions outweighed the drug's modest benefits. Lorcaserin is an appetite suppressant, similar to Fen-Phen, but is purported to be much safer.

Those on the FDA panel raised concerns about tumors seen in test rats in the early stages of testing of the drug. Other safety concerns included increased rates of depression and memory loss among test patients taking Lorcasering compared to those who were given placebos.

The FDA is not required to follow the panel's advisory vote and will make its own decision by Oct. 22. The panel's vote is a major setback for Arena Pharmaceuticals, the San Diego-based company which currently has no drugs available on the U.S. market. Lorcaserin is one of three drugs competing to be the first new prescription weight loss drug approved by the Food and Drug Administration in more than 10 years.

Earlier this year, the same FDA panel voted against recommending approval for a diet drug called Qnexa, made by Vivus Inc., due to safety concerns. Another pharmaceutical, Orexigen Therapeutics, is scheduled to have its own diet drug reviewed by the panel.

Both of those test drugs showed more promise than Lorcaserin, but the drug was favored by analysts because of its perceived safety and lower incidence of side-effects.

Nearly all FDA panelists agreed Arena Pharmaceuticals had met the FDA's requirements for achieving weight loss, but the majority said they were "troubled" by tumors seen in the animal studies. Also, the panelists were not pleased with the fact that Arena had not studied the drugs effect on patients with diabetes, heart disease and other conditions which are common among obese and overweight people.