OTTAWA, Sept. 15, 2016 /CNW/ - Health Canada is releasing an updated Labelling Standard for over-the-counter acetaminophenproducts to help consumers use these products more safely. Product packages will include clearer instructions and stronger warnings to help reduce the potential for liver damage. This change is one of a number of steps Health Canada is taking in light
Acetaminophen is a drug used in a wide range of non-prescription and prescription products, including headache and pain remedies, allergy medicines, cold remedies, and opioid pain relievers. With hundreds of different products available, it is one of the most commonly used pain and fever relievers in Canada.
Acetaminophen is used safely by the vast majority of Canadians. But like most health products, it can have risks, especially if too much is taken or if it is taken for longer than directed. These risks include liver damage, which in severe cases can lead to liver failure and even death.
Improvements to the Labelling Standard include:
The revised standard and the recommendation for children's dosing devices address recommendations coming out of the safety review. As an added safeguard, Health Canada is also issuing a Notice to industry advising of a policy to limit the amount of acetaminophen in prescription combination products (that is, products that also contain other drugs) to no more than 325 mg. No prescription products on the market currently contain more than 325 mg, but the action will discourage future products. Health Canada has also initiated ongoing work with stakeholders to raise public awareness of the risks of acetaminophen.
The label changes apply immediately to new products that companies are looking to introduce into the Canadian market. Companies with products already on the market are expected to update their product labels within 18 months. The Drug Facts table will be required on all products by 2021.
Other risk mitigation strategies considered in discussion with patient, consumer, health professional and industry stakeholders, such as reducing the recommended daily maximum or the unit dose for some products, will not be pursued at this time due to a lack of scientific evidence that these strategies would improve overall safety and concerns about possible negative impacts on consumers, such as driving them to other pain and fever relievers that have their own risks and may be less appropriate for them.
Health Canada continues to monitor acetaminophen's safety and to raise awareness of its risks, as it does for all drugs available in Canada. If new information emerges suggesting the need for further action, Health Canada will consider and act on it as necessary.
What you should do:
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SOURCE Health Canada
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