Other safety alerts
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| Canada: New safety information for prescription-strength ibuprofen: Risk of heart attack and stroke at high doses |
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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.
Healthcare professionals are advised of the following:
• Consider the cardiovascular risks when prescribing ibuprofen for all patients. These risks increase with dose and duration of therapy.
• Not to prescribe iIbuprofen doses of 2400 mg per day in patients with ischemic heart disease, cerebrovascular disease, congestive heart failure or with risk factors for cardiovascular disease.
• Consider other management strategies that do not include NSAIDs first (particularly COX-2 inhibitors, ibuprofen or diclofenac NSAIDs) for patients with a high risk of a cardiovascular event.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../53055a-eng.php
In Hong Kong, there are 84 registered pharmaceutical products (excluding external preparations) containing ibuprofen, and are pharmacy-only medicines. So far, the Department of Health (DH) has not received any adverse drug reaction reports on ibuprofen. Safety alerts regarding the cardiovascular risks associated with NSAIDs has been released by various overseas regulatory authorities, and was posted on the Drug Office website since 2011. Letter to healthcare professionals to draw their attention to the alerts was issued on 30 September 2011. The matter related to cardiovascular risk of NSAID was discussed in the meeting of the Registration Committee of the Pharmacy Poisons Board (the Committee) in February 2013. The Committee concluded that NSAIDs-containing products, other than external preparations and aspirin, should include new safety warnings regarding the cardiovascular risk. Latest news specifically on cardiovascular risk related to high dose ibuprofen has been released by the EMA, and was posted on the Drug Office website on 14 April 2015. As previously reported, the matter will be further discussed in the Committee's meeting. In view of the latest Health Canada's announcement, the information will also be forwarded to the Committee for consideration. The DH will remain vigilant on any safety updates of the drug by other overseas regulatory authorities.
Ends/ Friday, April 24, 2015
Issued at HKT 14:00
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