Lawsuit Seeks to Block Sales of Redux, Fen-Phen Medications
A federal court lawsuit filed Friday seeks to halt the sale of popular weight-control drugs that have been linked in some studies to heart disease and brain damage.
The suit seeks an order to the Food and Drug Administration to block sales of dexfenfluramine, also known as Redux, and to forbid the combination use of fenfluramine and phentermine, commonly known as fen-phen.
It also asked for a declaration that “Redux and the . . . use of the combination of phentermine and fenfluramine constitute an imminent public health hazard of epidemic proportions.”
The suit was filed by two organizations representing obese people and six individuals who claim they have been injured by the drugs.
The suit asks that drug companies provide unspecified compensation to pay for medical expenses for illnesses stemming from use of the drugs.
In addition to the FDA, the suit also names the Department of Health and Human Services, parent agency of the FDA, and 11 drug companies that make at least one of the drugs.
The suit, filed in the U.S. District Court for the District of Columbia, claims the weight-control drugs “are unequivocally linked to serious and fatal illnesses” by causing damage to the heart and the nervous system.
Don McLearn of the FDA noted that the weight-control drugs already are under close scrutiny. “I think we have already taken appropriate action” based on the current scientific evidence, he said.
The FDA in July warned doctors to be very careful in use of the fen-phen combination because studies at the Mayo Clinic had linked the drugs to heart valve damage.
Wyeth-Ayerst Laboratories Co., one of the makers of both fenfluramine and Redux and a defendant in the suit, also warned against fen-phen in letters to 460,000 health care workers.