FDAnews Drug Daily Bulletin


June 1, 2006

Final judicial approval has been given to an amendment to Wyeth's national legal settlement related to fen-phen, clearing the way for the company to settle with the largest group of people who took the diet drugs fen-phen.

Under the so-called "Seventh Amendment," Wyeth will deposit $1.275 billion into a supplemental fund to be distributed on a pro rata basis to members of the matrix I and II claims, which are the least serious but most numerous claims in the settlement. The claimants first have to pass a medical review and meet other requirements.

The claimants are former users of Pondium (fenfluramine) and Redux (dexphenfluramine), two Wyeth drugs used in the fen-phen diet treatment. The drugs were recalled in 1997 after research showed they might cause heart valve damage and a fatal lung condition.

It its most recent SEC quarterly filing, Wyeth said that as of March 31, 2006, approximately 41,000 individuals have filed lawsuits against the company.