GLP‑1 news from 1997
2 dated, sourced GLP-1 developments from 1997: approvals, trial results, prices, lawsuits, compounding and culture.
- Competition
Manufacturers and FDA withdraw fenfluramine and dexfenfluramine over heart valve damage
On September 15, 1997, the makers of fenfluramine (Pondimin) and dexfenfluramine (Redux) and the FDA announced the drugs' withdrawal from the U.S. market after reports of valvular heart disease and pulmonary hypertension; phentermine, the other half of fen-phen, stayed on the market. Five echocardiographic surveys found valvular disease meeting the FDA case definition in 32.8% of exposed patients, and a national class settlement with American Home Products was approved in 2000 at $4.75 billion, later valued at roughly $7.65 billion.
- Competition
Fen-phen heart valve damage in 24 women triggered FDA advisory in July 1997
On July 8, 1997, 24 cases of valvular heart disease in women treated with fenfluramine and phentermine were publicly reported, and the FDA issued a public health advisory the same day. By September 30, the agency had received 144 reports, and 113 of 132 complete reports met its case definition for valve damage. Fenfluramine and dexfenfluramine were withdrawn from the U.S. market on September 15, 1997.