Overview of Phenylpropanolamine and Its Recall

PPA was used as an ingredient in prescription and over-the-counter cold remedies and appetite suppressants for over 50 years. At the time it was pulled from the market over six billion doses were sold every year in the United States.

In 1991 reports of a possible connection between the use of drugs containing Phenylpropanolamine (PPA) and strokes began to increase. As a result, Congress decided to hold hearings to address the safety of PPA.

By 1996 the FDA required that additional warnings be used on all drugs containing PPA, but they had not yet found much solid evidence linking the substance to a serious health issue. Then in 2000 Yale University completed a study specifically aimed at determining the health risk posed by PPA. Shortly after the study was released, the FDA withdrew approval of PPA and it was taken off the market.

The Yale University study showed a link to an increased risk of hemorrhagic stroke (bleeding into the brain and surrounding tissue) and determined that certain groups were at higher risk of hemorrhagic stroke than others. See Who's at risk?

In addition the study concluded that the side effects were just as likely to occur in patients using the recommended dose as in patients who were exceeding it. Some of the drugs that demonstrated a higher risk to women were Poscior, Seldane, Hismanal, and Propulsid.

Since 2000, evidence has surfaced that several of the major drug companies involved in the manufacture of PPA-containing products may have had information - long before it came to the attention of the FDA - that the drug was in fact linked to increased risk of stroke. See Questionable Ethics.