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PPH Lawsuits: What is the problem with Fen Phen?

Pondimin (also known as fenfluramine), and Redux (also known as dexfenfluramine), are prescription diet drugs that were distributed through doctors and weight loss clinics. When Pondimin and/or Redux were taken in combination with Phentermine, it was popularly referred to as Fen-Phen. Fenfluramine [fen] and Phentermine [phen], were separately on the market since the 1970s.

Physicians became interes
ted in combining the medications following the 1992 publication of a University of Rochester study conducted by Dr. Michael Weintraub wherein he described long-term successful weight loss results when combining the two medications. Soon after that, millions of people were presecribed the Phen-Fen combination.

The “Fen" (fenfluramine) had always been known to have an appetite suppressing effect, but had the undesirable side effect of making people sleepy. The gist of combining the drugs was to counterbalance this sleepiness by adding “Phen" (phentermine), a mild stimulant. The drugs were then marketed under the catch phrase "fen-phen".

Fen-phen refers to the combination of fenfluramine and phentermine. Phentermine has also been used in combination with dexfenfluramine (dexfen-phen). Fenfluramine (fen) and phentermine (phen) are prescription medications that have been approved by the FDA for many years as appetite suppressants for the short-term (a few weeks) management of obesity.

The two drugs were around a long time before they were used together. Phentermine was approved in 1959 and fenfluramine in 1973. Dexfenfluramine (Redux) was approved in 1996 for use as an appetite suppressant in the management of obesity.

Recently, some physicians have prescribed fenfluramine or dexfenfluramine in combination with phentermine, often for extended periods of time, for use in weight loss programs. Use of drugs in ways other than described in the FDA-approved label is called "off-label use." In the case of Fen-Phen and dexfen-phen, no studies were presented to the FDA to demonstrate either the effectiveness or safety of the drugs taken in combination. (Source: FDA)

 


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