Information Update - New safety information for prescription-strength ibuprofen: Risk of heart attack and stroke at high doses

OTTAWA, April 23, 2015 /CNW/ - Health Canada is working with the Canadian manufacturers of prescription oral ibuprofen products to update the safety information regarding the risk of serious cardiovascular side effects (e.g., heart attack and stroke) when these products are used at high doses (at 2400 mg/day). This risk increases with dose and duration of use.

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used for pain and fever relief, and to reduce inflammation. The majority of ibuprofen products in Canada are available over-the-counter. These products have a maximum recommended dose of 1200 mg per day and are to be used for a short duration of time (seven days or less). No evidence of an increased cardiovascular risk has been found with over-the-counter ibuprofen when used as directed.

Serious heart- and stroke-related events are a known risk with all NSAIDs and the prescribing information contains extensive warnings on this risk.

The new information is in light of a Health Canada safety review that found that oral ibuprofen taken at high doses (at or above 2400 mg per day) increases the risk of heart attack and stroke. The increased risk with high doses of ibuprofen is similar to the risk seen with some other NSAIDs, including COX-2 inhibitors (e.g. celecoxib) and diclofenac. Health Canada recently communicated new prescribing recommendations regarding the cardiovascular safety of diclofenac.

Health Canada's review concluded that the benefits of prescription oral ibuprofen products continue to outweigh the risks as an effective pain and inflammation treatment, but that additional measures are needed for these products to further reduce the cardiovascular risk.

Prescription oral ibuprofen products have a maximum recommended daily dose of 2400 mg, and are authorized to relieve the pain and inflammation of rheumatoid arthritis and osteoarthritis.

Health Canada will be working with Teva Canada Ltd., Apotex Inc., and Pharmascience Inc., the Canadian manufacturers of prescription oral ibuprofen products, to strengthen the existing cardiovascular safety warnings in the prescribing information (product monographs), including recommending that doses of 2400 mg per day should not be used in patients with a history of heart disease and stroke, or who have risk factors for cardiovascular disease. Risk factors include -- but are not limited to -- smoking, diabetes, high blood pressure, high blood cholesterol and strong family history of cardiovascular disease.

Health Canada has also posted a Summary Safety Review with more information on its review.

What you should do:

• Patients currently taking high doses of prescription ibuprofen (2400 mg per day) should talk to their healthcare professional about whether or not ibuprofen use is right for them. This applies in particular to patients who have risk factors or who have already had a heart attack or a stroke. Risk factors include: smoking, high blood pressure, diabetes, high blood cholesterol, heart failure, and heart disease.
• Canadians taking ibuprofen or any NSAID product, be it prescription or over-the counter, are reminded that these drugs should be used at the lowest effective dose and for the shortest period of time necessary. Over-the-counter ibuprofen products should not be taken for more than seven days unless recommended by a healthcare professional.
• Patients with questions or concerns about their ibuprofen treatment are encouraged to speak to their healthcare professional.

Additional information for health professionals:

• Healthcare professionals should consider the cardiovascular risks when prescribing ibuprofen for all patients. These risks increase with dose and duration of therapy.
• Ibuprofen doses of 2400 mg per day should not be given in patients with ischemic heart disease, cerebrovascular disease, congestive heart failure or with risk factors for cardiovascular disease.
• Other management strategies that do not include NSAIDs -- particularly COX-2 inhibitors, ibuprofen or diclofenac NSAIDs -- should be considered first for patients with a high risk of a cardiovascular event.

Report health or safety concerns:
To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Related links:

• Diclofenac – Update to heart and stroke related safety information and decrease in the maximum recommended daily dose for tablets and suppositories – Health Professional Communication; Public Communication; Summary Safety Review (October 2014)

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SOURCE Health Canada

Media Inquiries: Health Canada, [phone]; Public Inquiries: [phone], 1-866 225-0709