Diclofenac tablets reclassified as a prescription medicine with an associated drug recall

This reclassification, effective from 15/01/2015, is due to a small but increased risk of serious cardiac adverse effects found in some patients taking diclofenac, particularly if used at high doses and for long-term treatment.

An analysis of the initial Europe-wide review of cardiovascular safety of NSAIDs by the Commission on Human Medicines (CHM) concluded that cardiovascular adverse effects cannot be ruled out even when diclofenac 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 (POM).

 

In response to this reclassification, the MHRA has issued a recall of all oral diclofenac presentations with legal status ‘P’. Topical diclofenac products remain available for purchase from pharmacies.