FDA delays approval of new diet drug amid cancer concern
May 13, 1998
Web posted at: 2:06 a.m. EDT (0606 GMT)
WASHINGTON (CNN) -- Government approval of a new weight-loss drug has been delayed until its maker can prove it does not increase the risk of breast cancer, CNN has learned.
The drug in question is Xenical, made by Hoffman LaRoche, which works by preventing the body from absorbing about a third of the fat ingested.
The U.S. Food and Drug Administration has issued a "letter of approvability," which delays approval until the questions concerning the cancer risk are addressed.
A Hoffman LaRoche spokesman told CNN the studies needed to satisfy the FDA could be completed by early 1999.
An FDA advisory panel was deadlocked last March when it voted on a recommendation to approve Xenical.
One side effect of Xenical is cramping and diarrhea.
Unlike Xenical, previous diet drugs, such as Redux and Phenfluramine, best known as the "phen" in Fen-Phen, worked on the brain to control the body's feeling of "fullness".
Redux and Phenfluramine were pulled from the market last September amid concern of possible heart problems related to them. Those drugs are the subject of ongoing studies as to their long-term safety.
Consumer demand for a new weight-loss drug is enormous. Redux and Phenfluramine were heavily prescribed before being pulled from the market.
Expectations were high for Xenical, according to weight-loss experts.
Recently-delayed approvals include a new drug designed to slow the effects of Lou Gehrig's disease, the french abortion pill RU-486, and new uses for thalidomide, which caused serious birth defects when first introduced in the 1950's.