November 6, 2000FDA Issues Public Health Warning
as a nasal decongestant (in over-the-counter and prescription drug products) and for
weight control (in over-the-counter drug products.)
DC (SafetyAlerts) - The Food and
Drug Administration (FDA) has issued 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 (PPA)
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
FDAs 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
In the meantime, FDA stated 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. There is
no known 'inclusive' list of products containing PPP available. Consumers can check
with their health care provider or pharmacist to see whether their prescription cough-cold
or nasal decongestant product contains phenylpropanolamine. FDA advises consumers to
discuss alternative over-the-counter and prescription products with their health care
providers or pharmacists.
More Information can be found on the
FDA information page here.
Notice of this product warning was
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