Herbal fen-phen products are unapproved new drugs, FDA tells consumers.
This article was originally published in The Tan Sheet
Executive Summary
"HERBAL FEN-PHEN" PRODUCTS ARE UNAPPROVED NEW DRUGS, FDA declares in a "Talk Paper" issued Nov. 6. Because the herbal products' names "reflect that they are intended for the same use as the anti-obesity drugs, fenfluramine and phentermine," the products are unapproved new drugs that "have not been shown to be safe or effective and may contain ingredients that have been associated with injuries," the agency states. Wyeth-Ayerst recently withdrew Pondimin (fenfluramine) and Redux (dexfenfluramine) from the market due to adverse events associated with coronary artery valves and primary pulmonary hypertension.