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Diet drug users urged to see doctor
November 13, 1997
Web posted at: 7:08 p.m. EST (0008 GMT)ATLANTA (CNN) -- Anyone who has taken the diet drug Redux or the popularly prescribed drug mix "fen-phen" should see a doctor for a heart examination, government health officials warned Thursday.
The warning comes two months after fenfluramine -- the "fen" in fen-phen -- and dexfenfluramine, marketed under the name Redux, were pulled from the market after questions arose about whether they damaged heart valves.
"We know that some individuals who have taken these diet medications have heart values that are thick and don't function properly," said Dr. Michael Friedman, acting commissioner of the U.S. Food and Drug Administration. "They can cause the heart to perform poorly over time and become weaker over time."
The recommendation of a heart examination is part of a new set of guidelines developed by the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health.
According to those guidelines:
- Anyone who has taken either Redux or fenfluramine, alone or in combination with any other weight-loss medication, should have a physical to find any signs of heart or lung damage.
- If the physical turns up anything unusual, or if a patient has noticed a shortness of breath, ankle swelling or a new heart murmur, then the patient should get an echocardiogram, a procedure that uses sound waves to detect heart abnormalities. It is painless and costs about $800.
- Doctors should strongly consider administering an echocardiogram to anyone who has taken the drugs and is about to have surgery or dental work, including dental cleanings -- even if the patient has no abnormal symptoms.
Surgery or dental work can allow bacteria to enter the bloodstream, and an echocardiogram can indicate whether the patient needs to take antibiotics beforehand to prevent endocarditis, a potentially serious complication.
Previously, the government had only recommended that people who took the diet drugs and had symptoms undergo an examination. But the FDA has estimated that perhaps 30 percent of dieters with no symptoms might have heart valve damage.
"Consumers ... and doctors have been calling in asking, 'What are we supposed to do now?" said Dr. Murray Lumpkin of the FDA, explaining the impetus for the new guidelines.
In serious cases, heart valve damage may require surgery to repair. The government has reports of at least three patients who died during surgery to repair valve damage traced to diet drugs.
Since 1995, 14 million prescriptions have been written for the two diet drugs.
Medical Correspondent Rhonda Rowland and Reuters contributed to this report.
Related stories:
- Consumers flock to alternative diet aids - November 3, 1997
- 2 popular diet drugs pulled from market - September 15, 1997
- Dieters switching to Herbal Fen-Phen - July 11, 1997
- Doctors say Fen-Phen causes heart disease - July 8, 1997
Related sites:
Note: Pages will open in a new browser window
- U.S. Food and Drug Administration (FDA)
- Centers for Disease Control and Prevention
- American Heart Association
- Fen/Phen Crisis Center
- Anita's Phen-Fen links
External sites are not endorsed by CNN Interactive.
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