The attorneys at The Higgins Firm have years of experience representing victims of some of the most dangerous drugs and defective medical devices on the market. One such drug that our Tennessee lawyers have experience litigating is the weight loss drug Fen-Phen. Fen-Phen was a popular diet drug in the nineties, but quickly became known for its harmful side effects. In the few short years it was on the market, over six million prescriptions for Fen-Phen were written. Shortly after it’s release, however, it became clear that the drug was causing severe heart and lung problems in those that were taking it. Today, the dangerous effects of Fen-Phen are still being felt by those who were prescribed the drug years ago. The Higgins Firm is dedicated to protecting the rights of those who have been injured by the drug Fen-Phen.
The Drug: Fen-Phen
The drug known as Fen-Phen is a combination of the drugs phentermine and fenfluramine. The combination was first marketed in 1992 by American Home Products (later known as Wyeth) as a weight loss pill and sold under the names Pondimin and Redux. Phentermine and fenfluramine were each approved by the FDA as weight loss drugs; however, both were only approved for short-term use. Fenfluramine works as a serotonin-releasing agent that suppresses one’s appetite and causes one to feel full after consuming small amounts. It is, though, associated with several negative side effects. Fenfluramine was known to cause --- and it was not very popular because it only temporarily reduced weight. Similarly, phentermine is a norepinephrine- and dopamine-releasing agent and appetite suppressant that temporarily reduces weight.
Years after the two drugs were approved by the FDA, one study found that a combination of the drugs produced long-term weight loss and also reduced many of the negative side effects associated with fenfluramine. Fen-Phen users were consuming low doses of phentermine and fenfluramine over a longer period of time and were not experiencing the expected drowsiness, insomnia, fatigue, irritability, etc. It was not until several years later that doctors realized that consumption of the drugs for extended periods of time could result in the development of harmful heart and lung diseases.
The Side Effects
Fen-Phen is often called an “off-label drug” because the combination was never approved by the FDA. Despite this, the drug hit the market in 1992 and doctors began prescribing the medication to millions of Americans. Just five years following its release, though, a study conducted by the Mayo Clinic reported the serious side effects connected to the use of Fen-Phen. The results of the study indicated that a third of participants surveyed developed heart damage after taking Fen-Phen.
Almost immediately, the FDA recalled the drug combination and removed it from the market. The quick action was likely due to the serious nature of the side effects experienced by patients. The two most common complications are heart valve disease (also called cardiac valvular disease) and primary pulmonary hypertension (also called pulmonary arterial hypertension). Primary pulmonary hypertension is characterized by the formation of scar tissue on the pulmonary artery, specifically on the inner lining. This can lead to a decrease in oxygenated blood as the scar tissue constricts blood flow through the artery. A patient with primary pulmonary hypertension can experience symptoms including fatigue, shortness of breath, fainting, high blood pressure, weakness, and enlarged liver. The disease can be treated, but there is no cure.
The second disease commonly found in patients who have taken Fen-Phen is cardiac valvular disease. Cardiac valvular disease is a disease that affects a person’s heart valves (there are four: pulmonary, aortic, mitral and tricuspid). Fen-Phen was found to cause both right-sided and left-sided heart damage. When the valves are damaged, the heart cannot correctly control and direct the flow of blood through the body. This can cause blood to leak back into the heart chamber. Ultimately, a person suffering from cardiac valvular disease can experience congestive heart failure, stroke, or pulmonary embolism. Heart valve disease can be treated with certain medications, but often surgery is required to fix the damage.
The Litigation That Followed
Within weeks of the Mayo Clinic report—even before the FDA recalled Fen-Phen—the litigation began. In the years following, hundreds upon hundreds of lawsuit were filed against the drug’s distributer, American Home Products (later, Wyeth). According to sources, more than 50,000 lawsuits were filed after the discovery of the drug’s dangerous side effects and over $14 billion has been paid to compensate those injured by the drug.
The long-term effects of Fen-Phen are still be experienced by those who were prescribed the drug years ago. Sometimes, the effects aren’t even noticed by patients until years after they have ceased taking the drug. Fortunately for those patients, a judge recently ruled that cases involving the late onset of symptoms can still proceed through the justice system despite the prolonged time period. However, such patients must act quickly as certain timelines may bar their claims.
Your Next Step
If you have been injured by the Fen-Phen drug, do not hesitate to call The Higgins Firm to learn more about your options. Our Tennessee lawyers are experienced in getting victims what they deserve, and your potential claim might entitle you to substantial compensation. Call our office today to discuss your next step.