Regulatory Focus™ > News Articles > UK's MHRA Puts New Restrictions on Popular Painkiller

UK's MHRA Puts New Restrictions on Popular Painkiller

Posted 14 January 2015 | By Michael Mezher 

UK's MHRA Puts New Restrictions on Popular Painkiller

A widely used over-the-counter painkiller has been reclassified as a prescription-only medicine (POM) by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

In a press release on 14 January 2015, MHRA announced that patients will now need a prescription to purchase diclofenac oral tablets. The agency cited concerns over “increased risk of serious cardiac side effects in some patients,” which is worsened by long-term or high-dose use. The decision to reclassify the drug was made following a review by the agency’s Commission on Human Medicines (CHM).

Reclassification and Recall

Diclofenac, a non-steroidal anti-inflammatory drug (NSAID), has been available in the UK since 1979. It previously held legal status “P,” meaning it could be purchased over the counter under a pharmacist’s supervision.

Before today’s reclassification, pharmacists were instructed to determine if patients purchasing diclofenac had an increased risk for cardiovascular disease. Additionally, pharmacists were advised to tell patients not to take more than one NSAID at a time and to seek a doctor’s advice before taking diclofenac for more than three days.

To facilitate the reclassification, MHRA has issued a Class 2 medicines recall, which requires action within 48 hours, for oral formulations of diclofenac. The recall instructs pharmacies and wholesalers to quarantine all stock of the drug marked with legal status ”P” and return the affected products to their original supplier for credit.

Previous Warnings over Diclofenac

The regulatory changes are not the first time MHRA has taken interest in diclofenac.

Following a review of the cardiovascular safety of NSAIDs by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee in 2013, MHRA warned that diclofenac should not be used in patients with “serious underlying heart conditions” and issued a drug safety update reflecting the new advice.

Concerns over Veterinary use of Diclofenac

The drug has also been linked to other, non-human concerns as well.

In 2006 the governments of India, Nepal, Pakistan and Bangladesh banned veterinary use of diclofenac after its use in cattle was linked to the steep decline in the region’s vulture population. Vultures that ate the carcasses of animals treated with diclofenac were found to suffer from kidney failure.

After receiving petitions from wildlife groups to ban veterinary use of diclofenac, the European Commission (EC) issued a request to EMA to conduct an investigation into the risk posed by the drug to vultures and other necrophagous birds in Europe. In December 2014 EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) issued an opinion stating that “vultures and other necrophagous birds may be at risk due to residues of diclofenac.” In the opinion, CVMP recommended implementing risk management measures, but was unable to make a specific recommendation on what actions the agency should take.


MHRA Press Release

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