Oral diclofenac tablets have been withdrawn from use as an over-the-counter (OTC) painkiller because of a small risk of heart problems, the Medicines and Healthcare Products Regulatory Agency (MHRA) has announced. The withdrawal is effective from 15 January 2015.

In August 2013 the MHRA consulted on whether the drug, which had been switched to a pharmacy (P) medicine in 2008, should revert to a prescription-only medicine (POM) after a European review found a small but significant elevated risk of cardiovascular side effects associated with the drug.

Following on from this, the UK’s Commission on Human Medicines (CHM) examined the data and concluded that these side effects may occur even when diclofenac is taken for a short time or at a lower dose, and that it should therefore be reclassified as a POM medicine.

Dr Sarah Branch, the MHRA’s deputy director of vigilance and risk management of medicines, said: “Diclofenac is associated with a small but increased risk of serious cardiac side effects in some patients, particularly if used at high doses and for long-term treatment.

“People who have been prescribed diclofenac… should continue to take their medicine as instructed as their medical history and any tests will already have been assessed.”

The MHRA has issued a class 2 drug alert for pharmacies to quarantine and recall all unexpired stock of diclofenac tablets. Topical diclofenac products, such as gels, are to remain available for purchase from pharmacies.