PPA is an
ingredient in many over-the-counter cough and cold remedies, appetite
suppressants and prescription decongestants. Phenylpropanolamine
is now believed to increase the risk of hemorrhagic stroke, especially
in young women. Phenylpropanolamine is an ingredient used in prescription
and over-the-counter drug products as a nasal decongestant to relieve
stuffy nose or sinus congestion and in OTC weight control drug products
to control appetite.
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 phenylpropanolamine. 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.