Two of the nation's most popular diet drugs - Redux and one half of the fen-phen combination - were pulled off the market Monday after being linked to serious heart damage.
The Food and Drug Administration recommended that anyone now using Redux, known chemically as dexfenfluramine, or Pondimin, known chemically as fenfluramine, stop taking the drugs and contact their doctors.Fenfluramine is half of the popular diet drug combination called fen-phen. The other half, phentermine, is not affected by Monday's withdrawal, but patients could no longer use the combination.
The FDA asked manufacturers to withdraw the drugs after reviewing the records of 291 patients and found 30 percent had abnormal echocardiograms - a test that shows doctors how the heart is functioning - even though they had no symptoms yet.
Some 92 patients had problems with their aortic or mitral heart valves, the data showed. The FDA said the numbers were much higher than it had expected, prompting the agency to recommend stopping sales of the drugs.
Wyeth-Ayerst Laboratories, which sells Redux and whose parent company makes Pondimin, said it agreed after seeing the government's data Friday.
"Our first commitment is to our patients and to their doctors," said Dr. Marc W. Deitch, senior vice president. "Even though this new information is not derived from a thorough clinical study and is difficult to evaluate, the company is taking the most prudent course of action."
The withdrawal comes after doctors at the Mayo Clinic announced in July they had discovered 24 cases of a rare heart valve defect in women who took fen-phen.