Fen-Phen Litigation
In the several year period leading up to July, 1997 the diet industry was in the throws of a revolutionary drug treatment thought to be capable of overcoming the limitations imposed by individual will power. The so called "miracle" treatment consisted of a combination of two drugs, dubbed "Fen-Phen" or "Phen-Fen". Separately, the weight loss results were not dramatic, but together the two drugs produced what was considered to be remarkable results. One study in 1992 claimed that 121 obese patients being treated with fen-phen lost an average of 30 pounds apiece. It has been estimated that in 1996 six million Americans took fen-phen to treat weight problems, and that in the same year approximately 18 million prescriptions for fen-phen were written. It all came crashing down when, on July 8, 1997, the FDA, in conjunction with the release of a manuscript of a Mayo Clinic study, issued a warning relating to evidence of heart valve problems associated with the usage of Redux and Pondimin. In August, 1997 the study was published in the New England Journal of Medicine. The FDA warning, followed by the reporting of the study in the New England Journal of Medicine, led to the September, 1997 withdrawal of Pondimin and Redux from the market place. While there were many reports of serious complications, such as primary pulmonary hypertension, from the drug combination prior to the Mayo Clinic study, the publicity surrounding the publication of the study and the FDA action in calling for a voluntary recall quickly produced evidence of much more widespread occurrence of these and other serious complications. The revelation of this medical crisis for potential victims has spawned a multitude of legal cases by those seeking to protect their health and preserve their legal recourse for injuries.
What should I do medically if I used these drugs?
The most frequently asked question concerning the use of these diet drugs is - What should I do? The U.S. Department of Health and Human Services and the Centers for Disease Control have sought to provide some guidance to the public by releasing the following guidelines for people who have used the diet drugs:
- Anyone who has taken fenfluramine (Pondimin) or dexfenfluramine (Redux) for any period of time, either alone or with another drug or drugs, should see their doctor for a medical history and physical examination to determine whether there are signs or symptoms of heart or lung disease.
- Anyone who has taken fenfluramine (Pondimin) or dexfenfluramine (Redux) for any period of time, either alone or with another drug or drugs, who has signs or symptoms of heart or lung disease, such as new heart murmur or shortness of breath, should have an echocardiogram performed.
- An echocardiogram should be strongly considered for any patient who has taken these drugs, either alone or with another drug or drugs, regardless of whether they have signs or symptoms of the heart or lung diseases BEFORE having any invasive procedure, for which the American Heart Association recommends antibiotic prophylactic treatment to prevent the development of bacterial endocarditis. This will provide an accurate determination of whether or not the person needs antibiotic treatment.
The term fen-phen is an abbreviation for the combination of two drugs. Fen or Fenfluramine is more commonly known as Pondimin. Phen or phentermine is more commonly known by its brand name Ionamin. Both drugs act to alter the serotonin levels in the brain. Serotonin at different levels acts to block feelings of hunger. Given each drugs ability to affect the serotonin levels in the brain, either separately or in concert, each drug is potentially neurotoxic. In combination these drugs are used to treat people who wish to lose weight. Unfortunately growing evidence suggests that fenfluramine taken alone or in combination with phentermine may be responsible for primary pulmonary hypertension, heart valve problems, and neurotoxicity of the brain.
What is Redux?
Redux, or dexfenfluramine, is another chemical derivative of fenfluramine which was approved for sale in the United States by the FDA in 1995. Like fenfluramine, Redux is an anorectic and was prescribed to induce weight loss. Also, like fenfluramine, Redux, upon mounting evidence that its usage may be responsible for primary pulmonary hypertension and heart valve disease, was withdrawn from U.S. markets in September, 1997.
What are Heart Valve Problems associated with these drugs?
Diet drugs can affect the valves of the heart in various ways. There are four main valves in the human heart -- the pulmonic, mitral, tricuspid, and aortic valve.
- The mitral valve can develop mitral stenosis, which is a narrowing of the mitral valve. This condition can impede blood flow from the left atrium chamber of the heart to the left ventricle chamber or can cause backflow of blood into the left atrium. These drugs can also cause mitral insufficiency, which results in the regurgitation (back-flow) of blood to the left ventricle.
- Aortic stenosis can be caused by the use of diet drugs. Aortic insufficiency results in increased left ventricular volume and decreased efficiency of the heart due to the back flow of blood.
- Tricuspid stenosis is generally encountered in association with mitral stenosis. Tricuspid stenosis causes pulsations of the jugular veins.
What is Primary Pulmonary Hypertension?
The pulmonary artery carries blood from the right ventricle of the heart to the lungs, where the blood will receive oxygen. Hypertension is simply an increase in blood pressure. Increased blood pressure in the pulmonary artery is pulmonary hypertension, which can often be traced to a demonstrable cause. Primary pulmonary hypertension, as distinguished from pulmonary hypertension, has been defined as the persistent elevation of pressure in the pulmonary artery without a known cause. This lack of a demonstrable cause frequently leads to its diagnosis only after the exclusion of all other physiological causes. Presently there is treatment, but no known cure, for this life threatening condition.
What types of Neurotoxicity are associated with these drugs?
Generally, neurotoxicity simply refers to substances which are poisonous to the central nervous system. Specifically, animal studies have raised concerns about dexfenfluramine's (Redux) toxic potential toward brain serotonin neurons.
What can I do legally to protect myself?
Ashcraft & Gerel has committed substantial resources to providing representation to a large number of persons already injured by the use of these drugs. We have set up a toll free number to answer your questions with regard to your specific case. That number is 1-800-725-6470. If you would prefer, please feel free to e-mail us or complete the help inquiry form on this web site. Please be sure to include your name, address, telephone number (if you wish to be called), email address and the exact nature of your question(s) so that we can provide you with the specific information you seek.