The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that drug companies discontinue marketing over-the-country weight-loss products containing PPA.

Phenylpropanolamine (PPA) is a synthetic sympathomimetic amine structurally similar to pressor amines (i.e., epinephrine, phenylephrine, and ephedrine) and central nervous system stimulants (i.e., ephedrine, amphetamine).

During the 1980s and 1990s, following its approval by the FDA, it was a common ingredient in over-the-counter weight-loss drugs as well as prescription and non-prescription cough and cold remedies. Each year, billions of doses were consumed in the United States, making PPA one of the most commonly used non-prescription medications

On December 22, 2005, the FDA issued a notice of proposed rulemaking products reclassifying phenylpropanolamine -- which it had approved a quarter of a century earlier -- as nonmonograph (Category II) not generally recognized as safe and effective.

The actions came after the FDA’s Nonprescription Drugs Advisory Committee concluded, largely on the basis of a Yale study, that use of products containing PPA increased the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain).

The Advisory Committee recommended that this drug be considered not safe for over-the-counter use.

In response to a request made by FDA in November 2000, many companies voluntarily reformulated and are continuing to reformulate their products to exclude PPA while FDA proceeds with the regulatory process necessary to totally remove PPA from the U.S. market.

Because of the difficulty in providing updated and accurate information as to which products already have been reformulated to eliminate PPA, the FDA recommends that consumers read the labels of OTC drug products to determine if the product contains PPA.