The Irish Medicines Board (IMB) has said people with heart problems using a commonly prescribed painkiller should review their treatment with a doctor, after the EU's medicines watchdog said it could exacerbate their conditions.
Diclofenac is a widely used medicine for relieving pain and inflammation – particularly with arthritis and acute musculoskeletal conditions.
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (Prac) investigated the drug after a request from the UK's medicines agency last October. The investigation concluded that – in general – the benefits of the drug "still outweigh" the risks.
Patients with “serious underlying heart or circulatory conditions” however should not use the drug at all, Prac said. These conditions include heart failure, heart disease, circulatory problems or a previous heart attack or stroke.
Patients who smoke or have cardiovascular risk factors such as high blood pressure, raised blood cholesterol or diabetes should use diclofenac only after “careful consideration”. The absolute cardiovascular risk depends on these underlying factors.
Healthcare professionals are also being advised to periodically re-assess the need for patients to continue taking the medicine.
The IMB said it was recommending patients to “consult their prescriber at their next scheduled appointment” – but stressed they should not stop taking the treatment without speaking to a doctor.
Consultant cardiologist and former medical director of the Irish Heart Foundation Dr Brian Maurer yesterday said it was a matter of "balancing risks" for patients.
