Diclofenac tablets have been reclassified as a prescription-only medicine (POM) due to a risk of heart problems, the MHRA announced today.

The NSAID tablets, used to treat pain and inflammation, were associated with a "small but increased risk of serious cardiac side effects" in some patients when used at high doses or for long-term treatment, the medicines watchdog said.

The reclassifcation will come into effect tomorrow (January 15), although topical products such as gels would remain available to buy over the counter, it stressed. As a result of the reclassification, it had recalled the drug from pharmacies, the MHRA said. 

The watchdog consulted on the availability of the drug in 2013, after a review by the European Medicines Agency the previous year found there was a "small but significant risk of cardiovascular side effects", the MHRA said. The organisation's Commission on Human Medicines has since concluded that these side effects can not be ruled out even when the medicine is taken for a short time or at a lower dose.

MHRA deputy director of vigilance and risk management of medicines Sarah Branch said patients needed a medical review before taking diclofenac tablets to ensure the treatment was suitable.

Patients who had recently bought oral diclofenac from a pharmacy should talk to their pharmacist about suitable alternatives for pain relief, while those who have been prescribed the drug from their doctor should continue taking their medicine as instructed, Dr Branch said.


In 2013, the MHRA warned that diclofenac should not be taken by patients with an underlying heart condition or those who had suffered a heart attack or stroke.

 

 

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