Dear Healthcare Professional Letter about the introduction of new contraindications and warnings after cardiovascular safety assessment of diclofenac in the EU Member States
15.11.2013
Farmal d.d., Fresenius Kabi d.o.o., Krka - farma d.o.o, PharmaSwiss d.o.o., Pliva Hrvatska d.o.o. and Sandoz d.o.o., marketing authorisation holders for systemic formulations of diclofenac-containing medicinal products in the Republic of Croatia, have in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals about important restrictions of use of diclofenac-containing medicinal products, following cardiovascular safety assessment in the EU Member States.
Summary
The benefits of diclofenac outweigh the risks. However, currently available data indicate that the use of diclofenac is associated with an increased risk of arterial thromboembolic effects, similar to those of selective COX-2 inhibitors
Use of diclofenac is from now on contra-indicated in patients with established congestive heart failure (New York Heart Association class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease. All those patients receiving diclofenac therapy should be re-evaluated periodically.
Diclofenac therapy in patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be prescribed after careful consideration
All patients should be treated with the lowest effective daily dose of diclofenac and at the shortest duration possible for re-evaluation of symptoms.
Additional information
Diclofenac is a widely used non-steroidal anti-inflammatory drug (NSAID) for relieving pain and inflammation. The Committee for Hzman Medicinal Products (CHMP) of the European Medicines Agency (EMA) reviewed the most recent data available in 2012 about the risk of cardiovascular events like heart attack or stroke, associated with the use of non-steroidal anti-inflammatory medicines. CHMP concluded that these data provided additional evidence of earlier known risks associated with these medicines. Overall, these findings consistently indicate a small increase of risk of cardiovascular events after use of diclofenac, similar to those of CoX-2 inhibitors.
Since this conclusion opened a safety issue of diclofenac, the EMA’s Committee for Pharmacovigilance and Risk Assessment (PRAC) started a comprehensive analysis of the cardiovascular risk associated with use of diclofenac in October 2012. Taken into account all available evidence, the PRAC endorsed the conclusion of the previous CHMP review and concluded that the benefits of diclofenac outweigh the risks. However, there is an increased risk of arterial thrombotic events associated with use of diclofenac, similar as for selective COX-2 inhibitors. The Summary of Product Characteristics and Package Leaflet will be updated with new information.
Here you may view the Dear Healthcare Professional Letter.
HALMED has not received any report to arterial thromboembolism associated with use of diclofenac. Among other cardiovascular events from 2005 by now, four cases of increased blood pressure and one case of extrasistole associated with use of diclofenac have been reported and all patients have been recovered from adverse reactions.
HALMED will continue to closely monitor the safe use of diclofenac-containing medicinal products and will inform promptly about any new information
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
