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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 phenylpropanoloamine 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.
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Phenylpropanolamine-containing products (OTC); tentative final monographs [PDF] [HTML]
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out-of-date list of products that may have already been reformulated and no longer contain PPA.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.
FDA’s 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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FDA Talk Paper on Phenylpropanolamine (PPA). 11/6/2000
Public Health Advisory. Subject: Safety of Phenylpropanolamine (PPA) 11/6/2000
Questions and Answers about Phenylpropanolamine (PPA). 11/6/2000
Science Background Statement on Safety of Phenylpropanolamine (PPA). 11/6/2000
http://www.fda.gov/cder/drug/infopage/ppa/ (1 of 2)20/07/2006 11:33:35
Phenylpropanolamine (PPA) Information Page
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FDA Letter to Manufacturers of Drug Products Containing Phenylpropanolamine (PPA) dated 11/3/2000. Optional Format: PDF
Posted 11/6/2000
Nonprescription Drugs Advisory Committee Meeting: Safety Issues of Phenylpropanolamine (PPA) in Over-the-Counter Drug
Products, (10/19/00). This link leads to the meeting agenda, roster, questions, presentation slides, and briefing information,
including the Yale Hemorrhagic Stroke Project: Final Study Report
Federal Register Announcement: Phenylpropanolamine; Proposal to Withdraw Approval of New Drug Applications and
Abbreviated New Drug Applications; Opportunity for a Hearing. Pages 42665-–42671 [FR Doc. 01-20300] [TXT] [PDF]
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Date updated: December 23, 2005
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Phenylpropanolamine (PPA) Advisory
U.S. Food and Drug Administration
• Center for Drug Evaluation and Research
Drug Information
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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-thecounter 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.
http://www.fda.gov/cder/drug/infopage/ppa/advisory.htm (1 of 2)20/07/2006 11:34:36
Phenylpropanolamine (PPA) Advisory
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FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DLIS
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