Wyeth To Begin Redux Neurotoxicity Study

Wyeth-Ayerst and Interneuron Pharmaceuticals have revealed that they areto conduct a postmarketing Phase IV study to investigate questions raised by earlier animal studies which indicated that brain serotonin levels are reduced following administration of high doses of the antiobesity drug Redux (dexfenfluramine).

Scientists had previously suggested that neurochemical changes seen in the high-dose animal studies indicated neurotoxicity or brain cell injury. However, upon termination of drug administration, these neurochemical changes were generally found to be reversible.

Researchers from the Columbia University College of Physicians and Surgeons in New York City will evaluate whether any cognitive, behavioral or psychological changes occur that can be attributed to altered serotonergic function in patients receiving Redux.