What are Fen-Phen & Redux?
Fen-Phen and Redux were, up until September of 1997, two of the most widely prescribed drugs or drug combinations for weight loss and weight control. Fen-Phen is a combination of Fenfluramine (Fen) and Phentermine (Phen), sold separately but prescribed in combination. Redux is a newer version of Fenfluramine (dexfenfluramine) which was prescribed by itself.
How did the drugs work?
Serotonin is a chemical within the brain that acts to give a person a feeling of “well being” and “fullness”. Fenfluramine and dexfenfluramine cause the brain to release an excessive amount of Serotonin, and, at the same time, block the body’s ability to reabsorb Serotonin. The excess Serotonin in the system makes you feel full and reduces hunger. Phentermine is an amphetamine or stimulant and has the ability to counteract the drowsiness of Fenfluramine. In 1992, a University of Rochester professor first promoted the drug combination, Fen-Phen, as a weight loss magic pill. Mass marketing of this combination followed, and in 1996 alone an estimated 18 million prescriptions were filled for Fen-Phen and Redux. These diet drugs were sold under a variety of trade and generic names including:
- Zantryl (Phentermine)
- lonamin (Phentermine)
- Adipex-P (Phentermine)
- Pondimin (Fenfluramine)
- Fastin (Phentermine)
- Redux (DexfenfluraiTiine)
Were These Drugs Approved By The FDA?
Fenfluramine and Phentermine have each been individually approved by the FDA, however, the combination of Fen-Phen was never submitted to the FDA, nor was it ever approved as a combination medication. Redux was approved by the FDA. In September 1997, at the FD/fe request, Pondimin and Redux were pulled from the market and are no longer available.
Who Manufactured These Drugs?
Several companies manufactured and distributed these drugs. American Home Products, and Interneuron Pharmaceuticals made Pondimin and Redux. In 1996 the sales of Redux accounted for approximately $132 million in revenue and the sales of Pondimin accounted for approximately $173 million in revenue for these manufacturers. Several manufacturers made Phentermine, which has been marketed under a number of brand names.
What are the health problems associated with these weight loss drugs?
Some of the side effects that have been reported and which maybe linked lo these drugs are as follows:
A. Primary Pulmonary Hypertension or PPH is a serious lung disease where the blood vessels constrict and create abnormally high blood pressure. Patients experience shortness of breath and fatigue. Unfortunately, PPH is usually a permanent condition and in many instances can lead to death.
B. Heart Valve Damage In July of 1997, the Mayo Clinic released the results of study which demonstrated that a large number of persons who had taken Fen-Phen or Redux had developed heart valve leakage. Heart valve damage in Fen-Phen users was 500% higher than in non users. A buildup occurs on the valves of the heart which prevents them from sealing properly as the heart chambers pump blood. This makes the heart pump much harder, and the valve deterioration can become life threatening, requiring surgical repair. Valve damage is generally a silent condition, causing no symptoms to the patient, until the condition becomes severe.
C. Other symptoms from the diet pills are:
- chest pain
- loss of energy
- swelling of extremities
- shortness of breath
D. Psychological or neurological problems such as short term memory loss, headaches, irritability, personality changes and depression. These symptoms are currently under investigation in relation to the taking of Fen-Phen and Redux.
What Does The Government Recommend?
Shortly after the PDA action and the withdrawal of the drugs from the market, a conference was held among the Food and Drug Administration, Department of Health and Human Services, Center For Disease Control and The National Institute For Health, with the assistance of numerous medical professionals. The conclusion was the issuance of a position paper which essentially recommended the following, at a minimum:
- Every person who has taken Fen-Phen or Redux should see a physician to have a complete medical history taken and a physical examination performed.
- If there is a suspicion of heart or lung disease, the patient should have an echocardiogram to determine the existence of heart valve damage.
- Even if there is no evidence of heart or lung disease, any Fen-Phen user that is about to undergo a medical or dental procedure, which is of a nature that an antibiotic would be prescribed for a heart patient, should also have an echocardiogram performed.
What is an Echocardiogram?
This is a non-invasive ultrasonic test of the heart. It provides the doctor with a “moving picture” of the heart and allows for a comprehensive analysis of heart valve functions and pressure.
How Do I Know If My Problem Is Caused By Fen-Phen Or Redux?
The level of this medical science is new and constantly developing. First, you should advise every treating physician of your history with Fen-Phen or Redux. Second, you should ask the physician directly, whether they are able to attribute your problem to any cause other than Fen-Phen or Redux. If your condition persists without any explanation, obtain a second opinion. Lastly, if you have any doubts about the source of your symptoms, insist on an echocardiogram. As a result of the FDA/DHHS position paper, the failure to prescribe this test to a patient with specific complaints could expose the physician to his or her own liability.
LEGAL ISSUES AND ANSWERS
What Are My Rights?
If you were a Fen-Phen or Redux user, and have suffered damages, you may have any number of claims, depending on your medical condition and the level of care you received. Some of the causes of action
- Individual actions against the manufacturers for failing to properly test the drugs and warn the public of known side effects and possible harm
- Class actions against the manufacturers seeking specific damage relief, or seeking long term medical monitoring of patients that have taken the drugs
- Medical malpractice actions against the prescribing physician for:
- failing to properly inform the patient of side effects before prescribing
- failing to properly diagnose a problem
- failure to monitor a patient under a drug regimen
- prescribing the drugs for an excessive period of time
- prescribing these drugs to persons who should not have taken them at all due to other prior health problems
What Should I Do Now?
1. Our first instruction to clients who have taken Fen-Phen or Redux, is to seek medical treatment, including an echocardiogram.
2. Complete the medical questionnaire from our firm and return it promptly.
3. Save all remaining pill bottles, prescription receipts or other evidence of the name, dosage, refill orders and the date of each prescription.
4. Save all medical bills and the literature that you received from the doctor or pharmacy about the drugs. If you were taking the drugs through a weight loss center, save all the forms and information that you were provided.
5. Write out a history of your involvement with the drugs, including start and end dates from when you took the drugs. Document all symptoms, your recollection of statements that the physician made, dates of visits, etc.
6. Do not discuss you involvement with the litigation with anyone.
7. Contact any of the attorneys listed in this brochure to discuss your case and to arrange for a free consultation.
8. Contact us immediately if your medical condition changes, or if you receive results from any testing.
What is the history or chronology of the diet drug settlement?
- September 15, 1997 – Diet drugs Pondimin® and Redux™ withdrawn from market
- Early winter 1997 – Lawsuits and class actions filed
- December 10, 1997 – Cases transferred to federal district court
- Early 1998 to Late 1999 – Negotiations between plaintiffs and drug manufacturers
- November 23, 1999 – Preliminary approval for the settlement class.
- May 2, 2000 – Hearings held to determine whether the proposed Settlement Agreement was fair, adequate, and reasonable.
- August 10, 2000 – Additional Hearings on the fairness of changes contained in the 4th Amendment to the Settlement Agreement.
- August 28, 2000 – Approval of settlement
- September 1, 2000 – AHP Settlement Trust established. The Trust is a special purpose entity established solely to administer the provisions of the Settlement Agreement, and to process the claims of Class Members who file claims with the Trust in connection with their use of Pondimin®and/or Redux™
- August 15, 2001 through October 3 2001 – Appeals
- January 3, 2002 – Final Judicial Approval occurred
The Law Offices of Nadrich & Cohen is a fifteen person law firm which does commit the necessary resources to fight any pharmaceutical corporation including the manufacturers of Redux and Pondimen and all other diet drugs. We work on a contingency fee basis. A contingency fee means we only obtain a fee if we make a recovery. If we do not win the case or make a recovery our clients owe us nothing for our time, costs or expenses.
With many decades of combined experience, the Law Offices of Nadrich & Cohen, and our highly experienced staff of trial attorneys, paralegals, investigators and law clerks have the expertise and ample resources to successfully research, investigate and litigate all of our clients Primary Pulmonary Hypertension claims. We promise every client that their claim will be reviewed diligently and carefully. If we take a case, we will work extremely hard to obtain the best possible result. We can help you immediately. All e-mail and form submissions will be responded to by a qualified member of our firm within 24 hours.