Drug Alert Following Concerns Regarding Cardiac Side Effect Risk

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.

Expert Opinion

This alert follows a review of oral Diclofenac conducted by the European Medicines Agency in 2013, which concluded that Diclofenac in tablet form created a significantly increased risk of arterial bloodclots, which can quickly lead to a heart attack or a stroke. For patients with a predisposition to clotting, such as those with heart disorders, Diclofenac was a risky product to take. <br/> <br/>"At the time, the EMA simply updated the product information leaflets, assuming that patients would identify the risks for themselves. This latest move follows a second review by the UK Commission on Human Medicines, which concluded that this class of drugs should not be issued without a proper patient assessment carried out by a qualified Doctor. <br/> <br/>"It is not realistic to expect patients to identify and assess for themselves the risks posed by this sort of drug. Whether or not a drug is safe for particular patient depends on a complex combination of factors. Where a life-threatening risk is posed, as it was with Diclofenac, the decision of whether or not to use it should be informed by expert medical advice. <br/> <br/>"The recall is a welcome but overdue step which will now significantly improve patient safety for those considering or already using this drug."