Diclofenac tablets, used to treat pain and inflammation, will no longer be available to patients without a prescription due to the small risk of heart problems.
The Medicines and Healthcare products Regulatory Agency announced the change today, noting that topical products, such as gels, will remain available for purchase from pharmacies.
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,” she added.
In August 2013 the MHRA consulted on the continued availability of oral diclofenac as a pharmacy medicine in the UK. It followed a European review that found there was a small but significant increased risk of cardiovascular side effects associated with diclofenac.
The product information for diclofenac was updated to reflect this new information. However, a further review of the evidence concluded that the side effects cannot be ruled out even when the medicine is taken for a short time or at a lower dose.
Therefore, in the interests of patient safety, the product is being reclassified to prescription-only medicine, said the MHRA.
It has issued a class 2 drug alert for pharmacies to quarantine and recall all unexpired stock of the drug, which is marketed by Novartis and Actavis.