Health Canada, Nov 6, 2000
2000-108
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.
Drug Products Containing Phenylpropanolamine (PPA) [in PDF format]
The text in this article was prepared by Health Canada.