Link Between Popular Diet Drug Combination and Heart Valve Disease Questioned
Link Between Popular Diet Drug Combination and Heart Valve Disease Questioned
Sept. 30, 1999 (Cleveland) - A new study challenges past research indicating that the diet drug combination known as fen-phen is associated with heart valve disease. Harvard researchers have found that only 8% of patients taking fen-phen had valve damage -- not more than 30%, as reported in 1997. At that time, the drug was swiftly pulled from pharmacy shelves.
Before the recall, fen-phen, marketed as Redux, was hailed as a miracle by weary dieters. The combination of fenfluramine and phentermine was said to suppress appetites over a prolonged period without any of the troubling side effects, such as insomnia and nervousness, associated with other drugs. At the height of its popularity, 6 million users filled more than 18 million prescriptions for fen-phen. Then came a report from the Mayo Clinic that an unusual and dangerous type of heart valve disease had been found in 24 fen-phen users. Within a matter of months the FDA ordered special studies of fen-phen users and the manufacturer, Wyeth-Ayerst, Co., voluntarily yanked the drug from the market.
But now Andrew J. Burger, MD, an assistant professor of medicine at Harvard Medical School, tells WebMD that people taking fen-phen may actually have less valve disease than the general population.
Burger says that when he and his colleagues studied the hearts of former fen-phen users by examining images of the heart, called echocardiograms, they actually found a "low prevalence" of valvular disease, with only 18 patients having significant abnormality of their heart valves. "These findings question the contribution of fen-phen therapy as an independent risk factor for [heart valve disease]," he and his co-authors write. The study results are published in the October issue of Journal of the American College of Cardiology.
He says he can't fully explain the difference between his findings and that of the investigators who conducted the FDA-ordered reviews. But says, "sometimes when you have a hammer the whole world looks like a nail."
When the Mayo researchers first sounded the fen-phen alarm, they reported that the patients had a thickening of the heart valves. Those patients underwent surgery to replace the diseased valves. Burger says none of the patients in his study have undergone surgery, so there has been no direct observation of the valves. But based on the images he says that it is unlikely that any of the patients in this study have had the changes described by the Mayo Clinic researchers. "The studies we did showed no thickening," Burger says.
Link Between Popular Diet Drug Combination and Heart Valve Disease Questioned
Before the recall, fen-phen, marketed as Redux, was hailed as a miracle by weary dieters. The combination of fenfluramine and phentermine was said to suppress appetites over a prolonged period without any of the troubling side effects, such as insomnia and nervousness, associated with other drugs. At the height of its popularity, 6 million users filled more than 18 million prescriptions for fen-phen. Then came a report from the Mayo Clinic that an unusual and dangerous type of heart valve disease had been found in 24 fen-phen users. Within a matter of months the FDA ordered special studies of fen-phen users and the manufacturer, Wyeth-Ayerst, Co., voluntarily yanked the drug from the market.
But now Andrew J. Burger, MD, an assistant professor of medicine at Harvard Medical School, tells WebMD that people taking fen-phen may actually have less valve disease than the general population.
Burger says that when he and his colleagues studied the hearts of former fen-phen users by examining images of the heart, called echocardiograms, they actually found a "low prevalence" of valvular disease, with only 18 patients having significant abnormality of their heart valves. "These findings question the contribution of fen-phen therapy as an independent risk factor for [heart valve disease]," he and his co-authors write. The study results are published in the October issue of Journal of the American College of Cardiology.
He says he can't fully explain the difference between his findings and that of the investigators who conducted the FDA-ordered reviews. But says, "sometimes when you have a hammer the whole world looks like a nail."
When the Mayo researchers first sounded the fen-phen alarm, they reported that the patients had a thickening of the heart valves. Those patients underwent surgery to replace the diseased valves. Burger says none of the patients in his study have undergone surgery, so there has been no direct observation of the valves. But based on the images he says that it is unlikely that any of the patients in this study have had the changes described by the Mayo Clinic researchers. "The studies we did showed no thickening," Burger says.
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