2011-05
January 13, 2011
For immediate release

OTTAWA - With the United States Food and Drug Administration (FDA) deciding to change dosage requirements for prescription acetaminophen combination products, Health Canada is updating Canadians on steps it is taking to determine if any new action may be needed to protect health and safety in addition to the recent updating of its acetaminophen labelling standard.

Prescription and non-prescription acetaminophen-containing products have a long history of treating pain and fever.  When used as directed, they are considered to be both safe and effective.

Concerns have been raised, however, by reports of acetaminophen overdose resulting in serious and sometimes fatal liver damage.

In September 2009, Health Canada finalized a new labelling standard for non-prescription products containing acetaminophen. This labelling standard contains warning of potential serious and possibly fatal liver damage in the event of an overdose.

Health Canada continues to review emerging and available safety evidence, including that used by the FDA to reach its decision and will determine if any new action may be needed to protect health and safety.

In addition, there are a number of steps everyone should follow to take medication(s) safely:

• Always read the product label and follow the instructions;
• Be careful when taking multiple products at once. For example, acetaminophen is contained in some pain relievers as well as decongestants and cough and cold remedies. In such cases, be careful to avoid exceeding the maximum recommended daily dosage of acetaminophen from the combined sources by considering product labelling and medication instructions;
• With prescription products, talk to your doctor, pharmacist or other health care professional and follow their instructions; and
• Know when to take medication, how often, and for how long.

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