Did Fen-phen Receive FDA Approval?
While the prescription medications fenfluramine, phentermine, and dexfenfluramine received individual approval by the U.S. Food and Drug Administration (FDA), use of the drugs in combination never received FDA approval. Use of approved drugs in ways other than described in the FDA-approved label is called “off-label use.” In the case of fen-phen and dexfen-phen, no studies were presented to the FDA to demonstrate either the effectiveness or safety of the drugs taken in combination.
