Wyeth/Interneuron Redux descheduling proposal by DEA issues one year after approval of obesity agent.
Executive Summary
DEA TO CONTINUE TO MONITOR FENFLURAMINE ABUSE POTENTIAL FOLLOWING DESCHEDULING of the agent and its isomers, including dexfenfluramine (Wyeth-Ayerst/Interneuron's Redux), the Drug Enforcement Administration stated in a May 6 notice proposing to remove fenfluramine (Wyeth's Pondimin) from Schedule IV of the Controlled Substances Act. "In light of the increasing availability and use of fenfluramine, particularly in combination with phentermine, and possible public health and safety risks including neurotoxicity, primary pulmonary hypertension and reports that fenfluramine may have pharmacological similarity to some hallucinogenic substances, DEA will carefully monitor the abuse, trafficking and diversion indicators regarding this substance," the notice states.