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Dieters get double-barreled warning about fen-phen
FDA, medical journal report more cases of heart damage
August 27, 1997
Web posted at: 11:46 p.m. EDT (0346 GMT)BOSTON (CNN) -- The U.S. Food and Drug Administration and the New England Journal of Medicine issued a double-barreled warning Wednesday about the dangers of taking the popular diet drug combination of fenfluramine and phentermine.
The FDA said the combination -- popularly known as fen-phen -- could damage heart valves.
CNN's Linda Ciampa reports
1 min. 53 sec. VXtreme video
In a report timed to coincide with the FDA warning, the Journal reported in its Thursday edition that a woman died after taking the drugs for only 23 days. Doctors said the 29-year-old obese woman died of a heart attack eight months after she first took the medicines.
The Journal first published the news three months ago that fenfluramine, sold under the brand name Pondimin by A.H. Robbins Co., and phentermine, sold by several manufacturers, could pose a risk to those with heart problems.
Both weight-loss medications have been approved individually by the FDA, but doctors have been prescribing them in a tandem known as fen-phen.
The FDA said Wednesday that it had received reports of 58 more cases of people with heart valve problems. The FDA's findings follow by only a month a study reported in July by the Mayo Clinic, which said it found that using fen-phen had caused a rare thickening of the heart valves in 24 people.
Fen-phen injures heart valve tissues
The heart has four valves that are supposed to close tightly and keep blood flowing in one direction. But in some people taking fen-phen, the valves don't close completely and blood leaks backward.
"For reasons that are not entirely clear yet, fen-phen seems to injure the tissues of the heart valves, rendering them incompetent," deputy editor Dr. Gregory Curfman wrote in an editorial in the Journal.
Nor does the problem seem to be restricted only to users of fen-phen. The Journal also reports on a letter from doctors who say they found the problem in a woman who had been taking dexfenfluramine, the chemical name for the popular diet drug Redux.
Redux and Pondimin were the subject of yet another warning Tuesday when the Journal of the American Medical Association associated their use with brain dysfunctions in animals, and as a possible cause of pulmonary hypertension.
Researchers reviewing 128 medical journal articles concluded that the drugs disrupted brain functions in animals, and may cause depression, memory loss, anxiety and sleep disorders in humans. They were also found to contribute to pulmonary hypertension, a life-threatening disorder that affects the supply of blood to the lungs.
FDA asks for 'black-box' warnings on labels
The FDA said Wednesday it is asking manufacturers of all three drugs to put so-called "black-box" warnings on the labels of their medications stressing their possible dangers.
It also said it would pressure the companies to help find a way to inform users of the drugs about the hazards.
Wyeth-Ayerst Laboratories of Philadelphia said earlier this week that it was working with the FDA on appropriate labeling, but it denied that it had failed to warn users of possible side-effects.
The company also said that numerous studies show that the drugs are safe when taken in proper dosages, and noted that in the animal studies, extremely high dosages were used.
Among the new findings published in the New England Journal of Medicine about fen-phen:
FDA researchers said they identified 58 new patients from 18 states with heart valve problems associated with the drugs. The typical patient began showing heart symptoms after 10 months. Six needed valve replacement surgery, and one died.
An FDA team found that the individual medicines might carry a serious risk. They said they received reports of valve problems in two patients who took fenfluramine alone; four who took dexfenfluramine; and two who took both dexfenfluramine and phentermine.
Brown University doctors say they identified a 32-year-old woman who developed a valve defect after taking dexfenfluramine for 10 months. The woman's case did not prove the drug caused the problem, but a heightened awareness of the problem "seems prudent on the basis of the growing concern" about the possible link, they said.
Fen-phen was prescribed to 18 million Americans last year. Pondimin and Redux are believed to be used by about 50 million Americans.
Although the drugs may be useful for carefully monitored obese patients with heart disease, diabetes, high blood pressure and high cholesterol who desperately need to lose weight, Curfman wrote in an editorial, "We should demand a moratorium on the use of anorectic drugs for the purpose of cosmetic weight loss."
Correspondent Linda Ciampa and Reuters contributed to this report.
- Consumer News: Fitness and Health - Obesity
Related stories:
- Study finds possible health risks in diet drugs - August 26, 1997
- Anti-obesity drug to get warning label - August 22, 1997
- Study: Fen-Phen causes heart disease - July 8, 1997
Related sites:
Note: Pages will open in a new browser window
- Journal of the American Medical Association (JAMA)
- Fen-Phen FAQ - site developed by the leading FEN/PHEN proponent and practitioner, Dr. Pietr Hitzig
- Fen-Phen, Side Effects - from California Weight Loss Associates
- U.S. Food and Drug Administration
- Pulmonary Hypertension Association
External sites are not endorsed by CNN Interactive.
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