Archived – Important Update Regarding Indications for Aspirin®

IMPORTANT DRUG SAFETY INFORMATION 

August 8, 2002

Dear Health Care Professional:

Re: Important Update Regarding Indications for Aspirin®

The purpose of this letter is to inform you of a factual error issued by Bayer in a press release dated July 31, 2002 regarding new indications for Aspirin® and to inform you of the Health Canada approved indications for Aspirin®.

Bayer incorrectly stated in a press release (31 July, 2002) regarding a new indication, that "Health Canada has approved the use of Aspirin® (ASA) for primary prevention, to reduce the risk of first heart attacks and strokes in individuals deemed to be at sufficient risk."

The new indication for Aspirin® applies to the reduction of risk of a first non-fatal heart attack and does not apply to primary prevention of stroke.

Aspirin® (acetylsalicylic acid, ASA) is indicated for the relief of pain, fever and inflammation of a variety of conditions such as influenza, common cold, low back and neck pain, dysmenorrhea, headache, toothache, sprains and strains, fractures, myositis, neuralgia, synovitis, arthritis, bursitis, burns, injuries, following surgical and dental procedures.

Aspirin® is also indicated for the following uses based on its platelet aggregation inhibitory properties:

• for reducing the risk of a first non-fatal myocardial infarction in individuals deemed to be at sufficient risk of such an event by their physician.
  • There is no evidence for a reduction in the risk of first fatal myocardial infarction. Aspirin does not reduce the risk of either cardiovascular mortality or first strokes, fatal or nonfatal.
  • The decrease in the risk of first non-fatal myocardial infarction must be assessed against a much smaller but not insignificant increase in the risk of haemorrhagic stroke as well as gastrointestinal bleeding.
• for reducing the risk of vascular mortality in patients with a suspected acute myocardial infarction;
• for reducing the risk of morbidity and death in patients with unstable angina and in those with previous myocardial infarction
• for reducing the risk of transient ischemic attacks (TIA) and for secondary prevention of atherothrombotic cerebral infarction;
• for prophylaxis of venous thromboembolism after total hip replacement
• for reducing the adhesive properties of platelets in patients following carotid endarterectomy to prevent recurrence of TIA and in hemodialysis patients with a silicone rubber arteriovenous cannula.

Please consider this information when using Aspirin® in your practice and if appropriate, provide to others involved with patient care in your professional environment. Bayer Inc. supports the appropriate and responsible use of all drug products and regrets the factual error in the announcement regarding the new indication for Aspirin®.

Bayer and Health Canada would also like to remind you of the importance of reporting adverse events associated with this or any medication. Reporting rates determined on the basis of spontaneously reported post-marketing events are generally presumed to underestimate the risks associated with medications, including Aspirin®.

The identification, characterization, and management of drug-related adverse events is dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Health care professionals are asked to report any suspected adverse reactions in patients receiving Aspirin® to Bayer Inc. or any other marketed product to the relevant company or to the Marketed Health Products Directorate at the following addresses:

Mr. Joseph Chan
Medical Information and Drug Safety Associate
Bayer Inc. Consumer Care Division
77 Belfield Road
Toronto, ON M9W 1G6
1-800-265-7382
joseph.chan.b@bayer.com

Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.

Further information may also be obtained by calling Bayer Inc. at 1-800-265-7382.

Sincerely,

Bayer Inc.

original signed by

Kevin Skinner
Vice President of Marketing and New Business Development

® Bayer, Bayer Cross and Aspirin are registered trademarks of Bayer AG. Aspirin is a registered trademark denoting Bayer's reliable brand of acetylsalicylic acid. Used under licence Bayer Inc. Toronto ON M9W 1G6

Any suspected adverse reactions can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Health Canada
Address Locator: 0201C2
Ottawa, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The ADR Reporting Form can be found in The Canadian Compendium of Pharmaceuticals and Specialties, or on the TPD website, along with the ADR Guidelines.