Phenylpropanolamine (PPA) Information Page
Update - On
December 22, 2005 the FDA issued a notice of proposed
rulemaking (notice) for over-the-counter (OTC) nasal
decongestant and weight control products containing
phenylpropanolamine preparations. This proposed rule
reclassifies phenylpropanolamine as nonmonograph (Category II)
not generally recognized as safe and effective. Written and
electronic comments and new data can be submitted by March,
22, 2006.
- Phenylpropanolamine-containing products (OTC); tentative final monographs
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The Food and Drug Administration (FDA) is taking steps to remove
phenylpropanolamine (PPA) from all drug products and has requested that
all drug companies discontinue marketing products containing PPA. In
addition, FDA has issued a public health advisory
concerning phenylpropanolamine. This drug is an ingredient that was used
in many over-the-counter (OTC) and prescription cough and cold medications
as a decongestant and in OTC weight loss products.
In response to the request made by FDA in November 2000, many companies
have voluntarily reformulated and are continuing to reformulate their
products to exclude PPA while FDA proceeds with the regulatory process
necessary to remove PPA from the market.
We have received numerous requests for a list of products containing
PPA. Since companies continue to reformulate their products, FDA is not
maintaining a comprehensive, updated list of products that still contain
PPA. FDA is aware of emails circulating widely that list many products
allegedly containing PPA. These emails, however, generally contain dated
and inaccurate information and should be ignored.
The FDA recommends that consumers read the labels of OTC drug products
to determine if the product contains PPA. The Agency believes this to be
the most accurate method for determining the PPA content of OTC products
rather than providing an incomplete or out-of-date list of products that
may have already been reformulated and no longer contain PPA. (Introduction updated 03/07/2003)
Scientists at Yale University School of Medicine recently
issued a report entitled "Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final
Report of the Hemorrhagic Stroke Project."
This study reports that taking PPA 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 PPA.
FDAs Nonprescription Drugs Advisory Committee
recently discussed this Yale study along with additional information on
phenylpropanolamine. The Advisory Committee determined that there is an association
between PPA and hemorrhagic stroke. It recommended that PPA be considered not safe
for over-the-counter use.
For more information on this public health advisory, please see the items below.
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Date updated: December 23, 2005 |