Health Canada proposes new liver damage labeling for acetaminophen

Health Canada announced it is requesting input from clinicians and other healthcare professionals on proposed revisions to the labeling standard for nonprescription acetaminophen products, in an effort to encourage consumers to use them more safely, according to a press release from Health Canada.

Labeling standards provide standardized information that companies include on their product packaging and inserts, such as information on dose, intended use, directions for use, warnings and active ingredients. The aim of the revised labeling standard is to help consumers more easily identify products that contain acetaminophen, understand the liver risks and use products as directed, according to the release.

The proposed revisions for product packages and labels include: “a prominent statement declaring the presence of acetaminophen so that consumers can more easily identify products that contain the drug; plainer language; a new drug facts table that provides dosing instructions, warnings and other safety information in a quick-reference, easy-to-read format; stronger, clearer warnings with respect to liver damage, including stronger warnings about use with alcohol; and clearer and more prominent dosing instructions to help prevent the risk of accidental overdose, including statements that emphasize the maximum daily dose, dose intervals and duration of use,” according to the release.

This new proposed standard follows a review that assessed acetaminophen and liver injury in the Canadian context, as well as a previous update to the labeling standard in 2009 that added stronger warnings on liver damage, according to the Health Canada website. Following the review in 2009, a guidance document known as the Acetaminophen Labelling Standard Guidance was released to update labeling language for nonprescription acetaminophen products.

If the new draft is finalized, it will replace the Acetaminophen Labelling Standard Guidance released in 2009.

Acetaminophen is the leading cause of acute liver failure in Canada, according to Health Canada. Canadians, health professionals, patient groups, industry and other interested parties are able to provide input on the draft standard until November 29. The draft standard is available on the Health Canada website.

Acetaminophen is found in approximately 500 nonprescription and prescription products in Canada, including headache and pain remedies, allergy medicines, and other medicines. It is the leading cause of acute liver failure in Canada, according to Health Canada.