Heart Failure Drug Manoplax Taken Off Market
WASHINGTON (AP) _ Manoplax, a drug for congestive heart failure, is off the market because a study showed it doesn’t work for long and it raised the risk of death for patients who kept taking it, authorities said Monday.
Boots Pharmaceuticals, the British manufacturer of Manoplax, said it was withdrawing the drug voluntarily after a study found that the beneficial effects did not last beyond three months.
Also, people who took the drug longer than that had higher hospitalization rates than those taking a placebo, according to a statement Monday by the Food and Drug Administration.
The company sent letters to doctors in April and May recommending that they stop using the 100 mg. dose of Manoplax because study results showed ″a significantly increased risk of death in patients taking the drug,″ the FDA statement said.
Those letters caused a sharp drop in the use of the drug in the United States, where an estimated 2,000 people are taking it now, the FDA said. The drug has been on the U.S. market since March.
It would be impossible to say how many deaths might be due to the drug because people taking it were close to death already, said a company spokesman quoted by the British news agency Press Association.
The company will continue to make the drug available on an experimental basis for patients who cannot tolerate withdrawal.
The FDA said patients taking Manoplax now should consult their doctors immediately but should not stop or change their dosage without getting medical advice first.
The company has set up a hot line for patients wanting additional information: 1-800-356-2225.