Fen-Phen Tests Suggest Heart Valve Leaks

By Staff Writer
fernandezfirm.com

August 10, 1999 (New York) - On Tuesday, American Home Products admitted that tests on patients taking its once-popular diet drug cocktail, Fen-Phen, for at least three months, suggested that some may have developed leakage in the heart's aortic valve. The leakages appeared on ultrasound tests known as echocardiographs.

However, New Jersey based pharmsuitical company stressed the tests in question were inconclusive, adding that 10 of its studies produced no solid evidence that its drugs caused heart valve problems or symptoms.American Home Products said that signs of possible leakage of the aortic valve occurred in patients who had taken either one or both drugs for more than three months and particularly in those patients who took the drugs for six months or longer.

American Home Products would not rule out that the valve leakages were due to pre-existing heart conditions or use of other drugs by the affected patients.

In 1997, the company recalled its diet drugs after the U.S. Food and Drug Administration provided echocardiographs from hundreds of patients showing possible links between the medicines and heart valve abnormalities and a dangerous condition known as primary pulmonary hypertension.

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