diet_drug_fda

diet_drug_fda

The troubled path of diet drugs continues to look challenging, especially after a U.S. Food and Drug Administration (FDA) panel recommended Thursday that the agency not approve a new anti-obesity medication—the second of three to come up for evaluation this year.

The new drug, called lorcaserin, acts on the brain’s serotonin, a neurotransmitter involved in appetite, digestion, memory, mood and other functions. Serotonin also plays a role in the cardiovascular system, and the diet drug fen-phen (fenfluramine and phentermine) was pulled from the market in the 1990s after it was linked to heart valve problems. When given in high doses, the new medication also gave many rats tumors (though human trials have not been linked to increase cancer risk). “In my opinion the potential risks of the medication outweigh the potential benefits,” Heidi Connolly, a panel member and professor of medicine at the Mayo Clinic, told Bloomberg News.

Other committee members, however, pointed more to a questionable level of efficacy than concerns over safety in their final vote, which was nine to five against approval. “I really didn’t have a lot of issues with the risk,” Eric Felner, a panel member and pediatric endocrinologist at Emory University, told The New York Times. “I just didn’t see it as being that efficacious.”

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