New contraindication on the use of high dose diclofenac for more than four weeks in selected groups of patients

HSA would like to inform healthcare professionals that the use of high dose systemic diclofenac (150mg/day) for more than four weeks is contraindicated in patients with established cardiovascular (CV) disease or uncontrolled hypertension. This regulatory decision was made following HSA's benefit-risk assessment, in consultation with its Product Vigilance Advisory Committee (PVAC) and several other clinical experts. The safety review was conducted in response to a growing body of scientific evidence suggesting that high doses of diclofenac used over a long duration is associated with increased CV risks. In addition to the new contraindication, healthcare professionals are advised that if diclofenac treatment is needed, patients with established CV disease, uncontrolled hypertension or significant CV risk factors (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated only after careful consideration and at doses ≤100 mg daily if the treatment is for more than 4 weeks. As the CV risks of diclofenac may increase with dose and duration of exposure, diclofenac should always be prescribed at the lowest effective daily dose and for the shortest duration possible.  Published: 27 Feb 2014

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