One of the most commonly used pain relievers on the market is also the leading cause of all serious liver injury, Health Canada says, prompting the department to roll out updated labelling standards for acetaminophen on Thursday.
The changes include instructions on packages to encourage the use of the lowest possible dose and warnings not to use the products for more than five straight days for pain or three days for a fever.
The department also recommends that adults not exceed the recommended daily dose of 4,000 mg for adults — the equivalent of 12 regular Tylenol tablets or eight extra-strength pills.
Label changes apply immediately for companies seeking to introduce new products, but companies already on the Canadian market will have 18 months to comply.
Acetaminophen presents a unique challenge for health care providers because it is so commonly used, Health Canada chief medical adviser Dr. Supriya Sharma said Thursday.
"It can be safely used if people are following the labels and the directions for use," she said.
"However, at the same time, is a product that is responsible for the most number of cases of acute liver failure in Canada ... I can't think of another product that is in this category."
The challenge for the department, practitioners and patients is to balance benefits with the risks, Sharma added.
"What we are putting forth today is our decisions on how to best mitigate those risks, while still allowing product to be available for patients who depend on it for pain relief and for fever and for treating other illnesses," she said.
Acetaminophen — in use for more than 50 years in Canada — is found in a wide range of non-prescription and prescription drugs, including opioid painkillers.
Health Canada's label update follows a safety review conducted on the drug in 2015.
It noted the drug is leading cause of all serious liver injury, including acute liver failure, in many countries, including Canada, the United States, the United Kingdom and Australia.
The review said there are more than 4,000 hospitalizations in Canada each year for acetaminophen overdose and approximately one in five involves someone who unintentionally exceeded the recommended dose.
It also discovered the number of hospitalizations for unintentional overdoses is on the rise in Canada and that the risk of overdose and liver injury spiked among users of prescription products which combine acetaminophen with an opioid.
Health Canada said Thursday it will continue to monitor acetaminophen's safety.
"Should a signal come up or should there be other information that we need to act upon, of course we will do that," Sharma said.
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