People will no longer be able to buy diclofenac tablets for pain relief without first getting a prescription from their GP, after the UK drugs regulator ruled it should no longer be available as a pharmacy medicine.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has decided that because diclofenac is associated with a ‘small risk’ of heart problems – especially when taken long term for chronic pain, and at higher doses – patients should have a review of their cardiovascular risk before being prescribed it.
The decision comes following a consultation on stopping the drug being sold over-the-counter, triggered by the European regulator’s decision that it should no longer be used by people with heart or vascular conditions, and only after ‘careful consideration’ in people with cardiovascular risk factors.
Dr Sarah Branch, the MHRA’s vigilance and risk management of medicines deputy director, 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. Because of this the Commission on Human Medicines has advised that patients need to have a medical review before taking oral diclofenac to make sure it is suitable for them.
‘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.
‘People who have been prescribed diclofenac from their doctor should continue to take their medicine as instructed as their medical history and any tests will already have been assessed. If you have any questions about your treatment you should discuss this with your doctor at the next visit.’
