Diclofenac maximum recommended dose reduced from 150 mg to 100 mg daily

Health Canada has approved revisions to the product labelling for all oral and rectal diclofenac products to reduce the risk of cardiovascular adverse events. The revisions apply to all diclofenac-containing tablets and suppositories, including Voltaren/Voltaren SR (diclofenac sodium), Voltaren Rapide (diclofenac potassium) and Arthrotec (diclofenac sodium/misoprostol).Diclofenac (diclofenac sodium) is indicated for the symptomatic treatment of rheumatoid arthritis and osteoarthritis. Diclofenac (diclofenac potassium) is indicated for the short-term treatment of acute, mild to moderately severe pain that may be accompanied by inflammation (e.g., musculoskeletal and/or soft tissue trauma such as sprains, postoperative pain following dental extraction, episiotomy or dysmenorrhea).The enhanced safety precautions were approved based on clinical evidence indicating that systemic diclofenac is associated with an increased risk of cardiovascular adverse events that is comparable to COX-2 inhibitors, particularly when diclofenac is used at high doses (150 mg/d). From January 1, 2008 to December 31, 2012, Health Canada received 39 reports of serious cardiovascular events (one fatality) potentially associated with systemic diclofenac use.The product labelling of all systemic formulations of diclofenac products is being updated to incorporate the following information:Diclofenac (tablets and suppositories), particularly at higher doses (150 mg/d), is associated with an increased risk of serious cardiovascular adverse events that is comparable to COX-2 inhibitors. Cardiovascular events (e.g., myocardial infarction, stroke, thrombotic events) can be fatal and their risk may increase with the dose and duration of diclofenac use.The maximum recommended dose of systemic diclofenac has been reduced from 150 mg per day to 100 mg per day for all indications. This excludes Voltaren Rapide for which a 200 mg dose is allowed only on the first day of treatment for dysmenorrhea.To minimize the potential risk for adverse cardiovascular events, the lowest effective dose of diclofenac should be used for the shortest possible duration.Diclofenac is not recommended in patients with pre-existing cardiovascular or cerebrovascular disease, or in those with risk factors for cardiovascular disease. For these patients, treatment options other than nonsteroidal anti-inflammatory drugs (particularly COX-2 inhibitors and diclofenac) should be considered first.The new safety update does not apply to topical formulations of diclofenac (e.g., topical gel or solution, eye drops).Health Canada has also released a public communication, advising patients to contact their healthcare provider if they are currently taking more than 100 mg per day of diclofenac.ReferencesHealth Canada. Diclofenac - update to heart and stroke related safety information and decrease in the maximum recommended daily dose for tablets and suppositories - for health professionals. October 6, 2014. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/41701a-eng.php (accessed October 7, 2014).Health Canada. Diclofenac - update to heart and stroke related safety information and decrease in the maximum recommended daily dose for tablets and suppositories - for the public. October 6, 2014. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/41703a-eng.php (accessed October 7, 2014).

Diclofenac maximum recommended dose reduced from 150 mg to 100 mg daily

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