Why is PPA – Phenylpropanolamine unsafe when this product has been in use for many years?
On May 11, 2000, FDA received results of a study conducted by scientists at Yale University School of Medicine that showed an increased risk of hemorrhagic stroke (bleeding of the brain) in people who were taking PPA – Phenylpropanolamine. PPA – Phenylpropanolamine has been used for many years and a very small number of people taking the drug have had strokes. The Yale study helped show that the number of people having strokes when taking phenylpropanolamine was greater than the number of people having strokes who were not taking phenylpropanolamine. Although the risk of hemorrhagic stroke is very low, FDA has significant concerns because of the seriousness of a stroke and the inability to predict who is at risk. Because of continued reports to the FDA of hemorrhagic stroke associated with phenylpropanolamine and the results of the Yale study, we now feel that the risks of using PPA – Phenylpropanolamine outweigh the benefits and recommend that consumers no longer use products containi