After reports of valvular heart disease and pulmonary hypertension primarily in women who had been undergoing treatment with fen-phen, the Food and Drug Administration (FDA) requested its withdrawal from the market in September 1997.
The action was based on findings from doctors who had evaluated patients taking these two drugs with echocardiograms, a special procedure that can test the functioning of heart valves. These findings indicated that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms. This is a much higher than expected percentage of abnormal test results.
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. FDA alerted medical doctors that it had received nine additional reports of the same type, and requested all health care professionals to report any such cases to the agency’s MedWatch program or to the respective pharmaceutical manufacturers.
Subsequently, FDA received 66 additional reports of heart valve disease associated mainly with "fen-phen." There were also reports of cases seen in patients taking only fenfluramine or dexfenfluramine. FDA requested that the manufacturers of fenfluramine and dexfenfluramine stress the potential risk to the heart in the drugs' labeling and patient package inserts. As of 1997, the FDA continued to receive reports of cardiac valvular disease in persons who have taken these drugs. This valvular disease typically involves the aortic and mitral valves.
As of 2004, fen-phen is no longer widely available. In April 2005, American Lawyer magazine ran a cover story on the fen-phen mass tort crisis and reported that more than 50,000 product liability lawsuits had been filed by alleged fen-phen victims. Estimates of total liability run as high as $14 billion.
Fen-Phen Safety Update Information
(fenfluramine, phentermine, dexfenfluramine)
The statements included in the background documents below reflect FDA's perspective on fenfluramine and dexfenfluramine based on the information available in November 1997. As fenfluramine and dexfenfluramine are no longer marketed in the U.S. and have no current FDA labels, we refer you to the medical literature to stay up-to-date on the emerging research on this topic.
To make finding this information more convenient for you, we have formulated several search strategies that will search for the current literature in MEDLINE, one of the most comprehensive medical information systems in the world. MEDLINE is produced by the U.S. National Library of Medicine; its web version PubMed is updated daily and is free of charge. To obtain very comprehensive medical literature searches or searches on other topics, we recommend contacting the reference librarians in your local public or medical library.
The table below covers two search topics; you can limit each of these to literature in all languages or in English only. The time span columns limits the search to new records added to MEDLINE over the most recent number of days. To use this search application, read across the table to choose the search you prefer; run the search by clicking on the time span.
Hackard & Holt is accepting new cases if you have been diagnosed with pulmonary hypertension or require heart valve surgery.
Hackard & Holt is also accepting new cases if you filed the Orange Form to opt out of the class action by March 30, 2000, and have proof of your use of Fen Phen.
Anecdotal evidence indicates that it is only recently that many former fen phen (fen-phen) users have come to terms with the causes of current physical impairment. This realization often comes about after their physician's review of their echocardiograms.
While the August 1996 New England Journal of Medicine report on "Appetite Suppressants and the Risk of Pulmonary Hypertension" was widely reported at the time, many fen phen (fen-phen) users were not then symptomatic or diagnosed. Now four years later, many former users need heart valve surgery and / or have been diagnosed with pulmonary hypertension.
Valvular dysfunction and blood regurgitation are the injuries associated with fen phen (fen-phen) related injury. Again, some former users are just now being diagnosed with these disorders.
Victims of fen phen (fen-phen) have filed scores of lawsuits around the United States in both state and federal courts. We represent dozens of seriously injured people and we have been fully prosecuting these cases within the judicial confines allowed in the various state and federal coordinated litigation.
While statutes of limitation might impact later accepted cases, we are still reviewing new pulmonary hypertension and heart valve surgery cases and would be happy to speak with you. Please use our contact form or call us on our toll-free telephone number.
American Home Products' agreement to settle will not bind all those injured by fen-phen. While the American Home Chairman and Chief Executive John Stafford called the diet drug controversy a "distraction," this "distraction" will continue to impact the lives of thousands of former fen-phen users and their families. It is not wise for those who have pulmonary hypertension or heart valve surgery to be unrepresented.
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