The findings of the Mayo Clinic were also reported in the August 28, 1997, New England Journal of Medicine, along with an FDA letter to the editor describing additional known cases of valve disease.
At that point, the FDA asked Wyeth to stress the risk to the heart in the drugs' labeling and package inserts. But on September 15, 1997, citing new evidence about significant side-effects, the FDA asked the company to remove both Pondimin and Redux, from the market. The action, it said, was based on findings by doctors who had evaluated patients taking the drugs with echocardiograms, a procedure that can test the functioning of heart valves.
"These findings," the FDA stated, "indicate that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms."
"The data we have obtained indicate that fenfluramine, and the chemically closely related dexfenfluramine," the agency warned, "present an unacceptable risk at this time to patients who take them."
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, the agency advised.
The reports of cases of heart valve disease in patients taking Pondimin or Redux alone prompted the FDA to advise patients using either of the drugs to stop taking them and contact their doctors to discuss treatment.
"These findings call for prompt action," said Michael Friedman, MD, the Lead Deputy Commissioner of the FDA at the time.
However, internal FDA documents have since surfaced in litigation that shows the FDA could have acted much sooner. As it turns out, a doctor from Fargo, North Dakota sent the FDA reports of valve damage associated with the diet drugs in February and March of 1997, and when he got no response, the doctor called the FDA in May of 1997, and had his assistant fax 25 reports to the official he spoke with.
But the official who received the information, did not alert her superiors and in fact, did nothing about the situation for a month, until she mentioned in a routine report that there was a doctor in Fargo who discovered problems with the drugs that should be tracked.
In describing valvular disease, the FDA's web site states: "There are four major valves controlling the flow of blood into, out of, and between the four chambers of the heart."
"Several disease processes," it explains, "including infection and toxicity, may damage the valves, causing them to malfunction, and may produce severe heart and/or lung disease."
Symptoms of the condition can include shortness of breath, swelling in the legs, chest pain and heart palpitations.
In some cases, the FDA says, medication can control heart failure associated with valvular damage but in others, surgery may be necessary to replace the valves with artificial valves.
Mass litigation followed the removal of the drugs from the market and continued as more studies confirmed their association with valve damage. By 1999, Wyeth faced nearly 20,000 personal injury lawsuits in state and federal courts, and more than 100 putative class actions, with some moving quickly toward certification.
The injuries alleged by plaintiffs included: heart valve regurgitation, valvular heart disease, or an increased risk of developing these conditions.
The plaintiffs claimed that Wyeth not only failed to do the testing that would have revealed the dangers of the drugs but that the company was fully aware that the fen-phen cocktail was being prescribed and sought to profit from the pairing of the two drugs. One complaint states:
At that point, the FDA asked Wyeth to stress the risk to the heart in the drugs' labeling and package inserts. But on September 15, 1997, citing new evidence about significant side-effects, the FDA asked the company to remove both Pondimin and Redux, from the market. The action, it said, was based on findings by doctors who had evaluated patients taking the drugs with echocardiograms, a procedure that can test the functioning of heart valves.
"These findings," the FDA stated, "indicate that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms."
"The data we have obtained indicate that fenfluramine, and the chemically closely related dexfenfluramine," the agency warned, "present an unacceptable risk at this time to patients who take them."
The reports of cases of heart valve disease in patients taking Pondimin or Redux alone prompted the FDA to advise patients using either of the drugs to stop taking them and contact their doctors to discuss treatment.
"These findings call for prompt action," said Michael Friedman, MD, the Lead Deputy Commissioner of the FDA at the time.
However, internal FDA documents have since surfaced in litigation that shows the FDA could have acted much sooner. As it turns out, a doctor from Fargo, North Dakota sent the FDA reports of valve damage associated with the diet drugs in February and March of 1997, and when he got no response, the doctor called the FDA in May of 1997, and had his assistant fax 25 reports to the official he spoke with.
But the official who received the information, did not alert her superiors and in fact, did nothing about the situation for a month, until she mentioned in a routine report that there was a doctor in Fargo who discovered problems with the drugs that should be tracked.
In describing valvular disease, the FDA's web site states: "There are four major valves controlling the flow of blood into, out of, and between the four chambers of the heart."
"Several disease processes," it explains, "including infection and toxicity, may damage the valves, causing them to malfunction, and may produce severe heart and/or lung disease."
Symptoms of the condition can include shortness of breath, swelling in the legs, chest pain and heart palpitations.
In some cases, the FDA says, medication can control heart failure associated with valvular damage but in others, surgery may be necessary to replace the valves with artificial valves.
Mass litigation followed the removal of the drugs from the market and continued as more studies confirmed their association with valve damage. By 1999, Wyeth faced nearly 20,000 personal injury lawsuits in state and federal courts, and more than 100 putative class actions, with some moving quickly toward certification.
The injuries alleged by plaintiffs included: heart valve regurgitation, valvular heart disease, or an increased risk of developing these conditions.
The plaintiffs claimed that Wyeth not only failed to do the testing that would have revealed the dangers of the drugs but that the company was fully aware that the fen-phen cocktail was being prescribed and sought to profit from the pairing of the two drugs. One complaint states:
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