What You Should Know
Fen-Phen claimed to help obese and overweight patients lose weight more quickly than diet and exercise alone. The prescription medication was a combination of Fen (fenfluramine) and Phen (phentermine). After a short while on the market, the drug manufacturer of Fen-Phen pulled the weight loss medication and faced more than $10 billion in legal liability cases. What caused Fen-Phen to be pulled from the market and why were dieters allowed to sue the company?
List of Ingredients
Prescription anti-obesity drug created from fenfluramine and phentermine.
When fenfluramine was created in the 1970s, very little weight loss was reported by people using the prescription medication so popularity waned. Wyeth then decided to package fenfluramine with Phentermine and creates Fen-Phen. Fen-Phen was similar to Aminorex which was already under investigation for causing lung damage. Despite the threat and the lack of accurate health warnings, Wyeth pushed Fen-Phen and popularity soared.
Over the course of only a few years, Fen-Phen was linked to severe health side effects including pulmonary hypertension. The New England Journal of Medicine tested Fen-Phen and revealed a 23-fold increase in risk of pulmonary hypertension when taking the drug. When warnings were sent out to physicians to watch for lung and heart troubles and soon doctors were reporting abnormal EKG tests in patients with no symptoms of a heart condition.
Even though the FDA stepped in and called for a complete recall of the medication, there is some fault to be placed on the Food and Drug Administration. In 1995, Leo Lutwak, MD of the FDA refused to sign paperwork required to pass Redux, a Fen-Phen derivative, into legal status. The FDA called in someone else to sign the required paperwork and the medication was available for sale with no health warning pertaining to the increased risk of pulmonary hypertension. At the same time, European drug officials required heavy warnings on Fen-Phen and Redux.
- Fen-Phen caused weight loss.
- Increased risk of heart problems.
- Increased risk of lung problems.
- Increased risk of death after taking the drug for a short amount of time.
- Abnormal EKG tests with no heart related symptoms.
- The drug is no longer legal for sale in the United States.
Fen-Phen was touted as the greatest weight loss prescription of its time. Behind the label were increased risks of life threatening health problems and disease that the manufacturer could have known about before placing the drug up for FDA approval or during the time when the drug was being prescribed. With more than 11,000 lawsuits and billions of dollars paid in settlements, Fen-Phen could be one of the most expensive mistakes Wyeth will ever make. Some cases are still outstanding as patients fight for more money from Wyeth.