Health Canada is proposing changes to the Acetaminophen Labelling Standard to minimize the risk of liver damage and improve acetaminophen safety. The last update to the Labelling Standard was in 2009 when stronger warnings were adding to non-prescription products to reduce the risk of liver damage.
Acetaminophen is one of the most commonly used pain and fever reliever in Canada with over 4 billion doses sold each year. The most common non-prescription Acetaminophen pain medication is Tylenol. Most people are aware Tylenol contains acetaminophen however, acetaminophen is found in many other non-prescription and prescription cold products such as Nyquil, Excedrin and Sudafed. Combining these products without being aware of the additive effects could lead to overdosing. Of the more than 250 cases of serious liver injury each year in Canada involving acetaminophen, over half involved accidental overdose.
The current recommended maximum daily dose is four grams per day and the maximum duration of use for pain relief is 5 days and 3 days for fever. Evidence has shown that doses above 10 grams per day in adults (or 150 mg/kg body weight/day) is damaging to the liver. However, there have been reports of liver injury in adults below the maximum recommended dose, especially for those individuals with conditions affecting the liver or use of acetaminophen for an extended duration of time.
To minimize the risk of liver damage, Health Canada is considering lowering the maximum recommended daily dose for all products and decreasing the unit dose for some products. Additionally, it is proposed that all children’s products be supplied with a dosing device to prevent the risk of dosing errors. The label formatting will also be revised to include a drug facts table that will provide safety information in an easy-to-read format and use plainer language so that consumers can more easily identify products that contain acetaminophen, understand the liver risks and use the product as directed.
A revised draft of the Acetaminophen Labelling Standard will be posted later this summer and a technical discussion with stakeholders to provide feedback on the proposed options is planned for fall 2015.