In the mid-1990s, a high number of overweight Americans were taking Fen-Phen with the promise of quick and effective weight loss. Fen-Phen contained the combination of two drugs called fenfluramine and phentermine. While one drug suppressed the appetite, the other drug prevented drowsiness. Patients quickly experienced dramatic weight loss and the drug was dubbed a “miracle pill”. The popularity of fen-phen was short lived, and scientific evidence surfaced showing a link between serious heart valve damage and a fatal lung condition called primary pulmonary hypertension (PPH). By then, millions of Americans had used Fen-Phen.
THE RISE & FALL OF FEN-PHEN
The story of fenfluramine diet pills (Fen-Phen, Redux, and Pondimin) began in the mid-1990s. In 1992, a study found that more than 1/3 of Americans were overweight, and people were looking for a quick and effective solution. The drug Isomeride was already popular in Europe, and contained fenfluramine, an “anoretic” drug that could make a person’s brain release serotonin, which made them feel full and satisfied. Isomeride and Pondimin (an older diet pill with fenfluramine), were not very popular because they made people feel drowsy. Fenfluramine also caused altered moods and memory loss. Then, a doctor decided to study whether the drowsy side effects of fenfluramine (“Fen”) could be fixed by combining it with another drug: Phentermine (“Phen”), a mild stimulant. Thus, Fen-Phen was born, and though it had not been approved by the FDA for weight-loss, doctors began prescribing it “off label” for quick weight loss. As the popularity of Fen-Phen began to explode, the drug-company pushed a second diet pill: Redux (dexfenfluramine). Though there was concern about the safety of Redux — including a study that linked derivatives of fenfluramine to Pulmonary Arterial Hypertension (PAH) — the company continued to push Redux onto the U.S. marketplace. Despite the advice of doctors who found a link between fenfluramine and Pulmonary Arterial Hypertension (PAH), the U.S. Food and Drug Administration approved Redux in April 1996.
With FDA approval, the diet pill craze began. The company marketing Fen-Phen and Redux spent $52 million on a massive advertising campaign that included articles in popular magazines. In 1996, sales topped $300 million, and there were more than 18 million prescriptions for the medications. However, the wild success would be short-lived, and soon come crashing down. The FDA began receiving reports from doctors that they were treating a wave of people with unusual heart valve damage and Pulmonary Arterial Hypertension (PAH) in patients taking Fen-Phen, Redux, or Pondimin. Even people who had only been taking the diet pills for a month showed signs of heart damage. On September 15, 1997, the FDA pulled Fen-Phen, Redux, Pondimin, and fenfluramine diet pills off the shelves and banned their use in the U.S.