Patients with serious underlying cardiovascular conditions should no longer receive the painkiller diclofenac, the Medicines and Healthcare products Regulatory Agency has ruled.
In a drug safety update it said diclofenac was now contraindicated in patients with ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or established congestive heart failure.
The MHRA warning follows the completion of a review on the non-steroidal anti-inflammatory drug by the European Medicines Agency research, which found a small increased risk of heart attack and stroke.
The level of risk is similar to that from selective COX-2 inhibitors, another group of painkillers previously banned from use in cardiovascular patients.
The EMA review concluded that overall, the benefits of diclofenac were greater than its risks, but there was a small risk of heart attack or stroke in patients taking systemic diclofenac regularly, especially at high doses (150mg daily) and for long periods.
If 1,000 patients at moderate risk took diclofenac for a year, there would be about three extra cases of heart attack among them, compared with patients not taking diclofenac.
Dr Sarah Branch, deputy director of the MHRA’s vigilance and risk management of medicines division, said: “Whilst this is a known risk and warnings have been included in patient and healthcare information for some time, this advice is now being updated.
“For many patients diclofenac will continue to provide safe and effective pain relief but is no longer suitable for certain at risk groups,” she added.