Class 2 medicines recall: Recall of all oral diclofenac presentations with legal status ‘P’

Pharmacies should have received a Class 2 medicines recall regarding oral diclofenac presentations that have a legal class "P" and their re-classification to POM.

For your information the details of the alert are below.  This needs to be actioned asap.

For further information please visit the MHRA website
http://www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON500350

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Dear Healthcare Professional

Oral Diclofenac: available only as a prescription medicine from 15th January 2015

Summary

Tablets containing diclofenac will be available only as a Prescription Only Medicine (POM) from 15th January 2015. Topical formulations containing diclofenac will continue to be available without a prescription.                      

Diclofenac is associated with a small increased risk of serious cardiac side effects in some patients, particularly if used at high doses and for long-term treatment.

The UK Commission on Human Medicines (CHM) has therefore concluded that patients need to have a medical assessment before taking oral diclofenac to determine if it is suitable for them.

Background

In 2013, a Europe-wide review concluded that systemic diclofenac is associated with a small increased risk of arterial thromboembolic events, similar to that of COX-2 inhibitors.   The European review recommended that the precautions to minimise the risks of arterial thromboembolic events with selective COX-2 inhibitors should be applied to systemic diclofenac. Product information for all systemic formulations of diclofenac was amended, adding a new cardiovascular contraindication and strengthening the warnings and precautions section.

The MHRA communicated the new recommendations to healthcare professionals on 28th June 2013.

Taking into account the new recommendations and the contraindications and warnings now in place to minimise the small risk of serious cardiovascular effects, and following a public consultation, the CHM concluded that diclofenac is no longer suitable for supply without prescription in the UK.

Advice for healthcare professionals

• Diclofenac tablets must not be sold without prescription from 15th January 2015.
• The sale of non-prescription oral diclofenac products must cease from 15th January 2015.   Remaining stock labelled for non-prescription use will be recalled from pharmacy.
• The updated prescription advice should be taken into consideration before prescribing diclofenac (see MHRA Drug Safety Update article from June 2013http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON286975 )

There is no requirement for patients to return these products if already purchased.  However, pharmacists are no longer permitted to supply non-prescription, oral diclofenac, and are advised to consider other treatment options for the management of pain in the non-prescription setting.  Other oral non-steroidal anti-inflammatory drugs and topical diclofenac containing products (gels) remain available without prescription, the latter due to their low systemic absorption.

Advice to give to patients

• There is no requirement to return oral diclofenac products which were available without a prescription if already purchased
• Your doctor or pharmacist can advise on suitable alternatives for pain relief which are available without prescription.
• This recall applies only to non-prescription diclofenac products – products applied to the skin (gels) are not included.
• If you have been prescribed diclofenac, there is no need to stop taking it. Speak to your doctor or pharmacist at your next routine visit if you have any heart problems or other concerns about the treatment.