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Fen-Phen Diet Drugs
Alley, Clark & Greiwe has represented more than 1,200 plaintiffs from throughout the State of Florida who have suffered injuries as a result of their ingestion of the diet drugs Redux and Pondimin. The firm has represented claimants in individual lawsuits in state and federal courts against the manufacturers of these drugs. Alley & Ingram was appointed as Plaintiffs' Liaison Counsel by the Court in the consolidated Diet Drug Litigation proceedings in Hillsborough County. The firm also currently represents clients in class action claims relating to these diet drugs.
Background Safety Information About Fen-Phen
In the mid-1990s, the diet drugs Redux (dexfenfluramine) and "fen-phen", a combination of Pondimin (fenfluramine) and phentermine were widely popular and ingested by more than 6 million Americans. The "fen-phen" combination was an "off-label" use of the drugs, as Pondimin and phentermine had never been approved by the FDA to be prescribed together and no studies had ever been conducted by American Home Products, the manufacturer of Redux and Pondimin, to determine whether the "fen-phen" combination was safe and effective. Also, Pondimin was only approved for short-term use, although many patients were prescribed "fen-phen" for a prolonged period of time. Redux was approved by the FDA in 1996 and aggressively marketed by American Home Products. Redux, was chemically similar to Pondimin, but was tested and approved by the FDA for use for a longer period of time.
In July of 1997, the Mayo Clinic reported that 24 patients had developed unusual plaques on their heart valves after ingesting the "fen-phen" combination. Five of these patients were required to undergo heart valve replacement or repair surgeries. On July 8, 1997, the Food and Drug Administration issued a Public Health Advisory describing the Mayo Clinic findings, which were reported in an August edition of the New England Journal of Medicine. By August, the FDA also reported that it had received reports of more than 100 cases of "fen-phen"-associated heart valve disease. There were also reports of heart valve disease in patients taken Redux, but no cases in patients taking phentermine alone. Throughout the Summer of 1997, American Home Products continued to market Pondimin and Redux despite these alarming reports of injuries associated with the product.
In September of 1997, the FDA reported that heart valve abnormalities were also being reported in patients who had ingested "fen-phen" or Redux but were largely asymptomatic. Echocardiograms on 291 patients revealed that nearly 30% had heart valve abnormalities, primarily involving the aortic and mitral valves. Following these reports, Pondimin and Redux were recalled on September 17, 1997. Since the recall, thousands of patients have been screened and diagnosed with diet drug-induced heart valve disease or primary pulmonary hypertension.
Fen-Phen Linked to Primary Pulmonary Hypertension
Primary Pulmonary Hypertension is an extremely rare condition in which the blood pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) remains elevated for an extended period of time. Eventually, this elevated pressure leads to narrowing and obstruction of the blood vessels of the lung, causing destruction of the lung tissue.
There have been reports over the years of an increased incidence of primary pulmonary hypertension in persons who have taken diet drugs. The incidence of this disease in the general population is only one to two persons per million. However, studies have shown that people who have taken diet drugs are 23 to 46 times more likely to develop this condition.
Symptoms Associated with Primary Pulmonary Hypertension:
- Shortness of Breath with Minimal Exertion
- Chest Pain
- Swelling of Feet and Legs
Poor Exercise Tolerance
Fen-Phen Linked to Valvular Heart Disease
The heart has four main valves that regular the flow of blood: the tricuspid, pulmonic, aortic and mitral valves. Pondimin and Redux have been shown to cause plaques on the aortic and mitral valves which prevent the valves from opening and closing properly and permits blood to leak or regurgitate backwards. Over time, this valve dysfunction can lead to heart failure, requiring surgical repair or replacement of the valve with a mechanical or artificial heart valve. Unfortunately, many patients with mild to moderate heart valve damage related to their ingestion of Pondimin or Redux are without symptoms. In its advanced stages, heart valve disease may cause shortness of breath, swelling of the legs (edema), chest pain, fainting and excessive fatigue. Diet drug-associated heart valve disease may be detected through a physical exam and detection of a heart murmur (abnormal sound as the blood flows over a valve). Heart valve disease, once suspected, is usually evaluated by an echocardiogram, a non-invasive, ultrasound of the heart and its structures.
Symptoms Associated with Valvular Heart Disease:
- Shortness of Breath
- Chest Pain
- Swelling of Feet and Legs
- Heart Murmur
- Excessive Fatigue
- Bacterial Endocarditis
Please contact Alley, Clark & Greiwe immediately If you or someone you love has been injured by the use of fen-phen or has developed Primary Pulmonary Hypertension.
Helpful Consumer Links about Fen-Phen:
- Click here for more information about PPH and fen-phen
- Click here for settlement announcement press release in 2000\
- Official Settlement Agreement
- Click here for Official Court Notice Of Nationwide Diet Drug Class Action Settlement
- Click here to read FDA Withdrawal Announcement in 1997