- Medicines and Healthcare products Regulatory Agency
- 22 January 2015
- Therapeutic area:
- Pain management and palliation and Rheumatology
Oral diclofenac is associated with a small increased risk of cardiovascular side effects and is therefore no longer available over the counter.
When prescribing or dispensing diclofenac, consider that:
- oral diclofenac must not be sold without prescription
- a recall has been issued for non-prescription diclofenac
- the prescribing advice for diclofenac was updated in June 2013
- topical formulations of diclofenac (eg gel and cream) remain available for sale over the counter
Advice to give to patients:
- if you have recently bought diclofenac tablets without a prescription and continue to need pain relief, speak to your prescriber or pharmacist who can advise you on suitable alternatives - there is no problem if you wish to stop taking diclofenac in the meantime
- if you have been prescribed diclofenac there is no need to stop taking the medicine - speak to your prescriber or pharmacist at your next routine visit if you have any heart problems or other concerns about the treatment
Diclofenac is a non-steroidal anti-inflammatory drug used to treat pain and inflammation. Diclofenac tablets must no longer be sold to anyone without a prescription. Diclofenac is associated with a small risk of serious cardiovascular side effects (eg myocardial infarction and stroke). Therefore patients should have a medical assessment before taking diclofenac to determine if it is suitable for them.
Reporting side effects
Please report any suspected side effects to any medicine or vaccine to the Yellow Card Scheme www.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of medicines.
Drug Alert 14 Jan 2015
MHRA press release 14 Jan 2015
Article citation: Drug Safety Update volume 8 issue 6 January 2015: 4
Published: 22 January 2015