The Food & Drug Administration (FDA) has called for the
withdrawal of all drugs containing phenylpropanolamine, also known as PPA, from the
marketplace.
The recall was based on evidence that the drug -- used in many over-the-counter (OTC)
and prescription cough and cold medications as a decongestant and in OTC weight loss
products -- is linked to an increased risk of hemorrhagic stroke, or bleeding into the
brain.
The ingredient is found in many popular products -- ranging from Dexatrim to Triaminic
-- and it is estimated that several millions Americans take PPA every day. The FDA
estimates that 200-500 people under age 50 may suffer strokes each year because of the
drugs. This age group is normally considered a low-risk group for strokes.
Scientists at Yale University School of Medicine conducted the study in which the
researchers found an association between phenylpropanolamine use and stroke in women. The
increased risk of hemorrhagic stroke was detected among women using the drug for weight
control, and for nasal decongestion, in the three days after starting use of the
medication. Men may also be at risk.
The Nonprescription Drugs Advisory Committee met on October 19 to discuss safety issues
related to phenylpropanolamine use. The committee reviewed Yale's Hemorrhagic Stroke
Project results and concluded that phenylpropanolamine cannot be considered to be safe for
continued use.
SOURCE: FDA Talk Paper, November 6, 2000.