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Drug Alert: Health Canada warns risk of heart attack and stroke with ibuprofen

April 23, 2015

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. 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.