MHRA Prohibits Over-The-Counter Sale Of Oral Diclofenac

Drug Alert Following Concerns Regarding Cardiac Side Effect Risk

19.01.2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued alert restricting the sale of the painkiller Diclofenac to a prescription-only basis.

The class 2 drug alert applies to Voltarol Pain-Eze, Pain-Eze extra strength 25mg  and Joint Pain 12.5mg tablets, which are manufactured by Novartis Consumer Health UK Limited.

In addition, other products affected are First Resort Double action Pain Relief 12.5mg and Boots Joint Pain relief 12.5 tablets, both manufactured by Actavis Group.

The decision to remove such products from sale follows studies which identified an increased risk of serious cardiac side effect in some patients, particularly if used at high doses and for long term treatment.

The MHRA has advised that patients who have bought the affected products should speak to pharmacists regarding potential alternatives, while those prescribed Diclofenac should continue to take the medicine as their medical history will already have been assessed.