Food and Drug Administration
Public Health Advisory
Subject: Safety of Phenylpropanolamine
November 6, 2000
The Food and Drug Administration (FDA) is issuing a public health advisory
concerning phenylpropanolamine hydrochloride. This drug is widely used as a nasal
decongestant (in over-the-counter and prescription drug products) and for weight control
(in over-the-counter drug products). FDA is taking steps to remove phenylpropanolamine
from all drug products and has requested that all drug companies discontinue marketing
products containing phenylpropanolamine.
Phenylpropanolamine has been marketed for many years. A recent study reported that
taking phenylpropanolamine increases the risk of hemorrhagic stroke (bleeding into the
brain or into tissue surrounding the brain) in women. Men may also be at risk. Although
the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any
products that contain phenylpropanolamine.
FDA’s Nonprescription Drugs Advisory Committee (NDAC) recently discussed this
study and other information on phenylpropanolamine. NDAC determined that there is an
association between phenylpropanolamine and hemorrhagic stroke and recommended that
phenylpropanolamine not be considered safe for over-the-counter use.
Although this 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. FDA
does not consider the conditions for which phenylpropanolamine is used (over-the-counter
or by prescription) as justifying the risk of this serious event. Other products are
available for use.
In the meantime, consumers can identify over-the-counter cough-cold, nasal
decongestant, and weight control products containing this ingredient by looking for
"phenylpropanolamine" in the list of active ingredients on the label. Consumers
can check with their health care provider or pharmacist to see whether their prescription
cough-cold or nasal decongestant product contains phenylpropanolamine. We advise consumers
to discuss alternative over-the-counter and prescription products with their health care
providers or pharmacists.
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FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
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