The NSAID diclofenac could be reclassified as a prescription-only medicine (POM) because of concerns over the cardiovascular risk associated with the painkiller.
The MHRA is consulting on plans to reclassify diclofenac tablets from a P medicine, it announced yesterday (August 5), after a review by the European Medicines Agency (EMA) last year found a small increased risk of heart attack and stroke among those taking the drug.Topical formulations would still be available without a prescription.
As an alternative to making the switch, the MHRA also proposed a range of measures to minimise the risks of OTC diclofenac, including strengthening the warnings about its cardiovascular risks and taking it with other NSAIDs, removing ‘for the symptoms of colds and flu, including fever' from the indications, and preparing a risk-management plan.
The MHRA's consultation is in response to a European warning on the cardiovascular risks associated with diclofenac
More on diclofenac
The MHRA also suggested engaging with pharmacists to "support the implementation of further measures" to minimise the risks involved in diclofenac being supplied over the counter.
The MHRA has not expressed a preference on what action to take and said yesterday it wanted to take into account all stakeholders' views before reaching a final position.
Pharmacy Voice immediately warned against reclassifying the painkiller. "There is no question in our mind that diclofenac products currently supplied as a P medicine are entirely suited to that category," chief executive Rob Darracott said yesterday.
"Pharmacists are well placed to advise on the management of pain and the risks and benefits of individual products. Furthermore, risk-management measures for other medicines sold by community pharmacies have proved effective, for example restrictions on the sale of pseudoephedrine."
As C+D broke the news on Twitter yesterday, pharmacist and C+D blogger Mr Dispenser said that patients rarely bought diclofenac as a P medicine because they required the higher dose available on prescription.
The MHRA issued guidance on the supply of the painkiller in June after the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended people with serious underlying heart or circulatory conditions should not use it.
However the Commission on Human Medicines (CHM) warned in the same month about the difficulties of identifying people with high cardiovascular risk, and highlighted that the wide availability of NSAIDs available as P and GSL medicines meant they could be taken together.
The MHRA consultation will run until October 8.
Do you think diclofenac needs to be reclassified as a POM?