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PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the effects of the painkiller diclofenac on the heart and circulation when given systemically (by means such as capsules, tablets or injections) are similar to those of selective COX-2 inhibitors, another group of painkillers. This applies particularly when diclofenac is used at a high dose (150 mg daily) and for long-term treatment. The PRAC concluded that the benefits of diclofenac still outweigh the risks but recommended that the precautions already in place to minimise the risks of arterial thromboembolic events (blood clots in the arteries) with selective COX-2 inhibitors should also be applied to diclofenac.

 

Patients who have serious underlying heart or circulatory conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke, should not use diclofenac. Patients with certain cardiovascular risk factors (such as high blood pressure, raised blood cholesterol, diabetes or smoking) should only use diclofenac after careful consideration. Healthcare professionals will also be advised to periodically re-assess the need for patients to continue taking the medicine.

 

 

Questions and answers on the PRAC recommendations are available here.

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