FDA Talk Paper, Nov 6, 2000
| U.S. Food and Drug Administration
FDA ISSUES PUBLIC HEALTH WARNING ON PHENYLPROPANOLAMINE
FDA, today, is taking steps to remove phenylpropanolamine from all drug
products and has requested that all drug companies discontinue marketing
products containing phenylpropanolamine.
FDA today issued a public health advisory concerning the risk of hemorrhagic
stroke, or bleeding into the brain, associated with phenylpropanolamine
Phenylpropanolamine is an ingredient used in many over-the-counter (OTC) and
prescription cough and cold medications as a decongestant and in OTC weight loss
Adverse events reported with these products led to concerns that this
ingredient might increase the risk of hemorrhagic strokes. Manufacturers of
products containing phenylpropanolamine worked with FDA to plan a research
program to clarify whether any increase in risk exists.
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 3 days
after starting use of the medication. Men may also be at risk.
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.
FDA believes that although the risk of hemorrhagic stroke is very low, even
with phenylpropanolamine use, the conditions for which these products are used
do not appear to warrant an increased risk of this serious event from using this
drug. We advise consumers to discuss alternative over-the-counter and
prescription products with their health care providers or pharmacists.
The text in this article was prepared by the FDA Office of Public Affairs.