Acetaminophen product makers told by Health Canada to boost warnings
Health Canada has told makers of over-the-counter products to provide clearer label instructions and stronger warnings on products containing acetaminophen in an effort to prevent liver damage.
Acetaminophen is used safely by the vast majority of Canadians, the regulator said in making the announcement Thursday.
But it comes with risks, especially if taken for longer than directed. These risks include liver damage, which in severe cases can lead to liver failure and death.
Acetaminophen is commonly associated with Tylenol. More than 475 different acetaminophen products are authorized for sale in Canada, the majority being non-prescription. These include combination products such as NyQuil and NeoCitran, as well as prescription medications.
Some of the instructions will warn consumers to:
- Use the lowest effective dose.
- Not to exceed four grams for adults in a 24-hour period.
- Use these products for no more than five days for pain or three days for fever.
- Not to mix them with alcohol if drinking three or more drinks in a day.
- Highlight how a product contains acetaminophen in bold, red lettering on the front of the package.
- Require calibrated devices for all liquid children’s products.
The label changes are effective immediately for all new products and within 18 months for existing ones.
A new Drug Facts table will also be required for packages to provide product instructions, warnings and other safety information in a consistent, quick-reference format, effective 2021.
The changes are based on the regulator’s safety review on the drug released last year.
Health Canada’s 2015 Acetaminophen Report showed more than 250 cases of serious liver injury every year related to acetaminophen.
About 1 in 5 cases is due to people exceeding the recommended dose unintentionally. In many of these cases, patients had identifiable risk factors for acetaminophen liver injury, such as alcoholism or viral liver disease, according to the report.
Originally posted here –