Once touted as a revolutionary breakthrough in the treatment of obesity, Fen Phen was a dual action dietary supplement, capable of promoting weight loss. However, clinical trials began to suggest that one component of the dual action formula may have been responsible for catastrophic side effects. Those who implemented a strict Fen Phen regimen may have significantly increased their risk of developing severe, life-threatening complications in the form of adverse cardiac events. Due to the severity of the corresponding complications, Fen Phen was recalled by the U.S. Food and Drug Administration (FDA) in 1997.
If you or a loved one has been injured by Fen Phen, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Fen Phen Lawsuit Overview
Fen Phen was an anti-obesity treatment that combined two anorectic drugs, fenfluramine and phentermine, to assist in the significant loss of weight. These distinct drugs were market by American Home Products, now known as Wyeth. Following mandatory regulatory actions, Fen Phen gained the approval of the FDA over two decades ago. However, it was not until the early 90s that the revolutionary weight loss supplement reached its pinnacle.
Fen Phen was the product of two medications that had already established themselves in the global market. Fenfluramine, the first of such drugs, has a unique mechanism of action that promotes the release of serotonin. Though ambiguous in nature, serotonin is believed to be linked to several brain functions, including that of satiety. Therefore, by releasing serotonin, fenfluramine promotes the stimulation of neurotransmitters that can potentially affect appetite.
The increased ratio of serotonin had a tendency to affect other aspects of an individual’s mood. Accordingly, developers incorporated an additional drug to counteract the corresponding mood swings. Researchers then added phentermine, a stimulant tasked with counter-balancing the negative effects of fenfluramine. By combining fenfluramine and phentermine, developers established the molecular entity that we know as Fen Phen.
Unfortunately, the pharmacodynamics of Fen Phen were found to be responsible for a variety of associated heart defects with varying degrees of severity. Subsequently, primary pulmonary hypertension (PPH) and several other heart complications became recognized cardiac abnormalities resulting from Fen Phen treatment. More specifically, consumers who used Fen Phen were at an increased risk of developing severe, life-threatening complications in the form of adverse cardiac events.
Fen Phen has since been recalled by the FDA. However, since its removal from store shelves in 1997, an influx of adverse events have plagued the industry. Accordingly, Wyeth has paid out over $20 billion in Fen Phen lawsuits. Due to the severe nature of these complications, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Fen Phen lawsuit.
Fen Phen Side Effects
The following is a comprehensive list of Fen Phen side effects:
- Severe heart murmurs
- Heart valve leaks
- Thickening of the heart valves
- Heart valve regurgitation
- Excessive plaque build up on heart valves
Unfortunately, numerous case studies have revealed that Fen Phen treatment increases the risk of developing these catastrophic health conditions by as little as 30%. Even more disheartening is the fact that signs and symptoms of these side effects may take 10 years or longer to be detected by a physician. The most serious of which include primary pulmonary hypertension and heart valve complications
Primary Pulmonary Hypertension
Primary pulmonary hypertension, otherwise known as pulmonary atrial hypertension, is characterized by a significant rise in the blood pressure within the pulmonary artery. While the reasoning for this condition remains ambiguous, research has indicted that Fen Phen may be responsible. The increased blood pressure makes it difficult for the heart to transport oxygenated blood to the rest of the body, resulting in several life-threatening complications. If PPH is left untreated, the heart muscles weaken and may eventually fail.
Fen Phen Heart Valve Problems
The fallowing Fen Phen heart valve problems have been associated with the popular weight loss supplement:
- Mitral Valve Stenosis – Occurs when the heart’s mitral valve becomes abnormally narrowed, resulting in restricted blood flow from the left atrium to the left ventricle.
- Aortic Stenosis – A condition commonly found in former Fen Phen users, aortic stenosis causes increased ventricular volume and decreased efficiency of the heart due to the backflow (regurgitation) of blood.
- Tricuspid Stenosis – Typically found accompanying mitral stenosis, tricuspid stenosis affects the flow of blood through the jugular veins.
The following FDA Public Health Advisory acknowledges the heart valve dangers associated with Fen Phen:
As of July 8, 1997, there have been 33 cases reported to FDA of unusual valvular morphology and regurgitation involving the mitral, aortic, and/or tricuspid valves, usually being multivalvular. About half of the women were reported to have pulmonary hypertension with their valvular disease. All 33 patients were American women with a mean age of 43.3 years (range: 35-72), all of whom had received combined fenfluramine and phentermine therapy for between 1 and >16 months (mean 10) before presentation with their valvular disease.
Fen Phen Recall
In July 1997, researchers at the Mayo Clinic and Mayo Foundation reported 24 cases of rare valvular disease in women who took the “fen-phen” combination therapy. The FDA alerted medical doctors that it had received nine additional reports of the same type. Acting on this evidence, the FDA asked the manufacturers to voluntarily withdraw Fen Phen treatments from the market in 1997. According to an FDA Advisory, the recall was based on data that indicted that approximately 30 percent of patients suffered from adverse events.
Do I Have a Fen Phen Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Fen Phen lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Fen Phen, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.