Kahtou 0004
Jan. 2001

Health Canada issues health advisory regarding phenylpropanolamine (PPA)

OTTAWA - Health Canada is issuing an advisory concerning phenylpropanolamine (PPA) and a reported association with haemorrhagic 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 haemorrhagic 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 for Health Canada is issuing this advisory in advance of the Department¹s 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 haemorrhagic stoke 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 haemorrhagic 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 US FDA¹s Non-prescription Drug Advisory Committee determined that there is an association between PPA and haemorrhagic stroke, and recommended that PPA not be considered safe for over-the-counter (non-prescription) use Though initial indications in the US were that many of the problems occurred as a result of the use of weight loss products containing PPA, the Yale study reports and 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 haemorrhagic stroke with PPA use has been reported to the Canadian Adverse Drug Research Monitoring Programme over the past two decades. Health Canada is currently evaluating the safety of PPA use in Canada in light of these US 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 contain 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 US may contain PPA. These products had the strongest association with haemorrhagic stroke and should not be used.

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