Diclofenac switches back to POM
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People can no longer purchase diclofenac tablets from community pharmacies without a prescription, following a change in the product's licence from P to POM status, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
The decision was made following advice from the Commission on Human Medicines (CHM), which concluded that patients should have a medical review before taking oral diclofenac, due to the small but significant risk of serious cardiovascular side effects. The MHRA held a consultation in August 2013 after a European review highlighted the risks, which led to the introduction of updated packaging. However, the CHM concluded that the risks could not be ruled out even when the medicines were taken at a lower dose for a shorter period of time.
Dr Sarah Branch, MHRA deputy director of vigilance and risk management of medicines, said: €If patients have recently bought diclofenac tablets from their pharmacy and continue to need pain relief, they should talk to their pharmacist about suitable alternative treatments. However, there is no problem if they wish to stop taking diclofenac in the meantime.€ Topical preparations containing diclofenac will remain available for sale over the counter under the supervision of a pharmacist.