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U.S. Food and Drug Administration • Center for
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Drug Information |
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Phenylpropanolamine (PPA) Information Page
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 hydrochloride. This drug is an ingredient used in many
over-the-counter (OTC) and prescription cough and cold medications as a
decongestant and in OTC weight loss products. 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. o
FDA Talk Paper on
Phenylpropanolamine (PPA). 11/6/2000. o
Public
Health Advisory. Subject: Safety of Phenylpropanolamine (PPA).
11/6/2000. o
Questions
and Answers about Phenylpropanolamine (PPA). 11/6/2000. o
Science
Background Statement on Safety of Phenylpropanolamine (PPA).
11/6/2000. o
FDA
Letter to Manufacturers of Drug Products Containing Phenylpropanolamine (PPA)
dated 11/3/2000. o
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. FDA/Center
for Drug Evaluation and Research |
Posted
11/6/2000. 
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ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.