1997 FDA Announcement Recalling Pondimin
August 19, 2001
URGENT NOTICE: In many instances, if you have not filed a complaint you may lose your rights to bring a claim or receive compensation for any valvular heart damage that you sustained from Fen-Phen diet drugs.
While there are some exceptions available to class members who timely requested a free echocardiogram under the Screening Program, to fully protect your rights you should immediately contact an attorney to determine if there are any important dates which are approaching. For this reason, you should act immediately.
The Food and Drug Administration, acting on new evidence about significant side-effects associated with fenfluramine and dexfenfluramine, has asked the manufacturers to voluntarily withdraw both treatments for obesity from the market. Dexfenfluramine is manufactured for Interneuron Pharmaceuticals and marketed under the name of Redux by Wyeth-Ayerst Laboratories, a subsidiary of American Home Products Corp. of Madison, N.J., which also manufactures and markets fenfluramine under the brand name Pondimin. Both companies have agreed to voluntarily withdraw their drugs. The FDA is not requesting the withdrawal of phentermine, the third widely used medication for obesity.
The action is based on new findings from doctors who have evaluated patients taking these two drugs with echocardiograms, a special procedure that can test the functioning of heart valves. These findings indicate 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.
"These findings call for prompt action," said Michael A. Friedman, M.D., the Lead Deputy Commissioner of the FDA. "The data we have obtained indicate that fenfluramine, and the chemically closely related dexfenfluramine, present an unacceptable risk at this time to patients who take them."
FDA recommends that patients using either of these products stop taking them. Users of these two products should contact their doctors to discuss their treatment.
These new findings suggest fenfluramine and dexfenfluramine are the likely cause of heart valve problems of the type that prompted FDA's two earlier warnings concerning fen-phen, a combination of fenfluramine and phentermine. "Fen-phen" has been widely used off-label in recent years for the long-term management of obesity.
In July, 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 (1-800-FDA-1088/fax 1-800-FDA- 0178) 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. FDA continues to receive reports of cardiac valvular disease in persons who have taken these drugs.
-- Article Courtesy of InjuryBoard.com
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