FDA Recall of Fen Phen

An FDA recall of Fen Phen was requested in September of 1997 after the commonly used diet drug was linked with the development of primary pulmonary hypertension (PPH) and valvular disease. Concerns were initially documented in July of 1997 when a study published by the Mayo Clinic suggested that certain diet drugs and their components may elicit deadly side effects. The Fen Phen recall was instituted to minimize the potential of any such side effects.

As of July 21st, 1997, the FDA had confirmed more than 45 cases of women who had suffered heart valve defects (valvular disease) as a result of using Fen Phen. Although no deaths had been reported in association with Fen Phen use, five of the aforementioned cases were serious to the extent that they resulted in open-heart surgery.

What is Fen Phen?

Fen Phen is a combination diet drug (anorectic) consisting of fenfluramine and phentermine. Fenfluramine (Pondimin) was later marketed using a somewhat altered formulation under the name of Redux (dexfenfluramine). In certain cases, phentermine was combined with dexfenfluramine to create an altered form of Fen Phen, equally capable of eliciting negative side effects. Although fenfluramine and phentermine had been marketed individually as anorectics since the 1970s, it wasn't until the 1990s that Fen Phen began to gain notoriety.

While Fen Phen, fenfluramine and dexfenfluramine have all been recalled, phentermine remains on the U.S. market as an anorectic and diet-suppression drug.

Fen Phen Side Effects - Determining the Link

The FDA's decision to suggest a voluntary recall of Fen Phen was based on the findings of doctor evaluations of Fen Phen users. Using specialized echocardiograms designed to monitor heart function, the doctors discovered that approximately 30% of the patients who were tested had abnormal results. This number represented a higher-than-expected percentage and therefore raised a red-flag with regards to Fen Phen use. Even more disturbing was the fact that the patients with abnormal echocardiograms were asymptomatic. Therefore, Fen Phen users could potentially continue using the anorectic long after its negative effects have become an issue.

Additional studies also showed that patients who took Fen Phen, Pondimin, or Redux were more likely to develop a case of PPH; particularly if treatment has lasted for more than three months. Such patients are as much as 28-times more likely to develop PPH than those being treated with safer alternatives.

Fen Phen Lawsuits

If you or a loved one has developed a case of primary pulmonary hypertension or valvular disease as a result of using Fen Phen, Pondimin, or Redux, you may be eligible to receive personal injury compensation from liable parties. As of 2004, Fen Phen was no longer widely available throughout the United States because of such liabilities. It has been estimated that there are more than 50,000 Fen Phen–related product liability lawsuits in the pipeline with potential liabilities exceeding $14 Billion. To get additional information about Fen Phen victims' rights or to discuss your options with regards to filing a Fen Phen lawsuit, contact the law offices of Ferrer, Poirot & Wansbrough at 800 521 4492 or visit the firm's website at www.ppa-injury.com.