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.
- Phenylpropanolamine-containing
products (OTC); tentative final monographs [PDF]
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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of OTC products rather than providing an incomplete or out-of-date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 |