Advisory
2001-61
May 30, 2001
Health Canada withdraws drug products containing phenylpropanolamine (PPA) from the market
OTTAWA - Health Canada would like to advise the Canadian public that it has completed an assessment of the safety of phenylpropanolamine (PPA), and as a result, drug products containing PPA are being withdrawn from the market. This drug ingredient was widely used in Canada as a nasal decongestant in prescription and nonprescription (over the counter) cough and cold, and sinus remedies, and some combination allergy medications.
On November 6, 2000 Health Canada issued an advisory recommending that consumers not take any products containing PPA because of a reported association with haemorrhagic stroke. At that time, in addition to a number of manufacturers voluntarily suspending sales of these products, a number of pharmacies and other retail outlets began to remove drug products containing PPA from the shelves.
On the basis of the information which was reviewed, Health Canada has concluded that it cannot presently justify the use of this ingredient in prescription and nonprescription drugs, however rare the event of a possible haemorrhagic stroke.
A regulatory process to remove all products containing PPA from the Canadian market has been initiated. The Drug Identification Numbers (DINs), which provide manufacturers with the authority to market drug products in Canada, for all products containing PPA have been cancelled. Manufacturers have been asked to remove all remaining products containing PPA from the retail market. A number of manufacturers have indicated that they are reformulating their cough and cold, sinus and allergy medications by either removing PPA or replacing it with a safe and effective alternative nasal decongestant.
Canadians are again advised not to use any products containing PPA. Also, Canadians are reminded at this time to dispose of any products containing PPA that may be in their medicine cabinets or otherwise stored in their homes. Products containing PPA can be identified by the word "phenylpropanolamine" in the list of ingredients on the label. Questions about the safe disposal of these products can be addressed to a pharmacist, or by calling the toll-free customer service number that appears on the label of the product.
A list of products containing PPA that were available on the Canadian market may be found at:
Media inquiries:
Roslyn Tremblay
Health Canada
(613) 957-1588
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