U.S.
Sender: owner-e-drug@usa.healthnet.org
Precedence: bulk
E-DRUG: Phenylpropanolamine to be banned in the U.S.
----------------------------------------------------
November 6, 2000
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 study and other information on
phenylpropanolamine. The Committee determined that
there is an association between PPA and hemorrhagic
stroke and recommended that PPA not be considered safe
for over-the-counter use.
For details, visit FDA's website: www.fda.gov. Also,
the New England Journal of Medicine has early released
the epidemiologic study referred to above. For
details, visit the journal's website: www.nejm.org.