Fen-phen maker agrees to $3.75 billion settlement

October 8, 1999
Web posted at: 12:14 p.m. EST (1614 GMT)

(CNN) -- American Home Products Corporation (AHP), makers of the diet drug combination fen-phen, agreed Thursday to pay $3.75 billion in compensation to thousands of people who used the diet drugs before they were removed from the market in 1997 after being linked to heart valve disease.

"Settling this matter was in the best interest of those who used Pondimin or Redux as well as of the company," said AHP President and Chief Executive Officer John R. Stafford. "We believe that this agreement is a sound way to resolve the claims raised by diet drug users and represents a prudent course for our company. It offers peace of mind to those who used the drugs and permits the company to move beyond the uncertainty and distractions of litigation."

Under the settlement, which is subject to court approval, AHP does not admit to any wrongdoing.

When doctors started prescribing Redux and Pondimin, which made up the fen-phen combination, it seemed like the answer to millions of Americans' weight-loss prayers. The drug combination melted away pounds.

But in July 1997, researchers at the Mayo Clinic issued a startling report linking heart valve disease with patients who took fen-phen.

As a result, Wyeth-Ayerst Laboratories, the pharmaceutical division of AHP, withdrew fenfluramine (Pondimin) from the market. Later in the year, the Food and Drug Administration advised those who took the drug combination to see their doctors.

Many doctors feared that perhaps millions of people who took fen-phen would develop heart problems, but those fears were unrealized.

Earlier this year, in the largest study of its kind, researchers attempted to pinpoint who was at risk for heart valve disease as a result of taking fen-phen.

The study concluded those who took the diet drug combination for less than six months did not develop heart valve disease any more often than those who never took the drug.

However, researchers found those who took fen-phen for more than two years had a 17 percent increased risk of developing heart valve disease.

Still, the controversy hasn't ended. Last week, a group of Boston researchers published a study concluding fen-phen has no role in causing heart valve disease, regardless of the length of time a person takes it.