This email is a follow up to the November 6, 2000 ennouncement concerning PPA.


November 6, 2000

Advisory Health Canada issues health advisory regarding phenylpropanolamine
(PPA)

OTTAWA - Health Canada is issuing an advisory concerning phenylpropanolamine
(PPA) and a reported association with hemorrhagic stroke. This drug is
widely used as a nasal decongestant in prescription and non-prescription
cough and cold, sinus and some combination allergy medications.

The risk of hemorrhagic stroke as a result of the use of products containing
PPA is low. However, because of the seriousness of a stroke and the
inability to predict who is at risk, Health Canada is following the lead of
the United States Food and Drug Administration (FDA) in issuing a public
advisory recommending that consumers not use any products containing PPA.

The Therapeutic Products Programme of Health Canada is issuing this advisory
in advance of the Department's full evaluation of the scientific and medical
questions concerning PPA. In Canada, products containing PPA are used for
relatively mild conditions. Given the risk of a more serious event such as a
hemorrhagic stroke and given the fact that these medications provide only
temporary relief, Health Canada is recommending, as a precaution, that
consumers do not use any products containing PPA until a full assessment has
been completed.

In the United States during the 1990s, a link between PPA and hemorrhagic
stroke had been suspected. Many of the affected patients had been young
women using PPA as an appetite suppressant. Problems often occurred as a
result of the first dose taken. It is important to note that PPA has not
been approved for use as an appetite suppressant or weight loss product in
Canada.

Based on its analysis of the results of a recently released study completed
at Yale University, the U.S FDA's Non-prescription Drug Advisory Committee
determined that there is an association between PPA and hemorrhagic stroke,
and recommended that PPA not be considered safe for over-the-counter
(non-prescription) use.

Though initial indications in the U.S. were that many of the problems
occurred as a result of the use of weight loss products containing PPA, the
Yale study reports an increased risk associated with cough and cold
medications. Most of these cases involved women but men may also be at risk.
Only one case of hemorrhagic stroke associated with PPA use has been
reported to the Canadian Adverse Drug Reaction Monitoring Programme over the
past two decades. Health Canada is currently evaluating the safety of PPA
use in Canada in light of these U.S. findings.

Consumers can identify over-the-counter nasal decongestant, cough and cold,
sinus and combination allergy medications containing PPA by looking for
"phenylpropanolamine" in the list of ingredients on the label. They may also
wish to consult with a pharmacist. Consumers should consult with their
health care provider or their pharmacist to see whether their prescription
nasal decongestant, cough and cold, sinus and combination allergy
medications or combination antibiotic-decongestant medications contains PPA.
Health Canada advises consumers to discuss alternative products with their
health care professional. The public should be aware that weight loss
products obtained from the U.S. may contain PPA. These products had the
strongest association with hemorrhagic stroke and should not be used.

Health Canada will keep the public informed as further information becomes
available.

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Media inquiries: Roslyn Tremblay Health Canada (613) 957-1588


Please note that there is further info at the New
England Journal of Medicine website, where the details
of the study re: PPA have been released ahead of
publication (due Dec 21, 2000) The address is
www.nejm.org