- Diclofenac, an anti-inflammatory drug, has been reclassified
- Is used by millions for conditions such as back pain, arthritis and gout
- But there were fears the drug could also cause heart problems
- Has now been re-classified and will only be available on prescription
An over-the-counter painkiller used by millions will no longer be sold in pharmacies from today, over fears that it could raise the risk of heart attacks and strokes.
Diclofenac pills will now only be available with a prescription.
The Medicines and Healthcare products Regulatory Agency said the painkilling and anti-inflammatory tablets, widely bought under the brand name Voltarol, carry a ‘small but increased’ risk of heart problems.
Diclofenac, an anti-inflammatory drug, has been reclassified by the UK healthcare regulator as a prescription-only medicine after concerns it may cause heart problems for some patients
Painkilling gels that contain diclofenac will still be available over the counter, however.
Diclofenac accounts for six million prescriptions, and it is thought that tens of thousands buy Voltarol directly over the counter.
The pills are non-steroidal anti-inflammatory drugs (NSAIDs), which are used to relieve pain caused by conditions including arthritis, gout, headaches and flu.
In 2013, Oxford University researchers found high doses of NSAIDs can increase the risk of heart attacks and strokes.
A review by European health officials confirmed the finding, and said patients should no longer use diclofenac if they have a heart condition, or have previously suffered heart attacks or strokes.
HOW THE PILLS CAN PUT YOUR LIFE AT RISK
Diclofenac – the active ingredient in Voltarol – offers fast relief from pain and inflammation associated with back, neck and muscle aches.
It also gives short-term relief from headaches, toothache, period pain and cold and flu symptoms.
It blocks a substance in the body called cyclo-oxygenase, which produces chemicals in response to injury – causing pain, swelling and inflammation.
In 2013, a major Oxford University study found that for every 1,000 people with a moderate risk of heart disease taking 150mg a day for a year, about three would experience an avoidable heart attack, of which one would be fatal.
Diclofenac can also cause serious side-effects in the gut, such as ulceration, bleeding or perforation of the stomach or intestinal lining.
The MHRA’s Commission on Human Medicines concluded that these side-effects could ‘not be ruled out’ even at lower doses, or when diclofenac is taken for a short time.
Pills containing diclofenac remain available over the counter in many other countries, including Germany, Italy and Australia.
However, the MHRA’s Sarah Branch said: ‘Diclofenac is associated with a small but increased risk of serious cardiac side effects in some patients, particularly if used at high doses and for long-term treatment.
Because of this, the Commission on Human Medicines has advised that patients need to have a medical review before taking oral diclofenac to make sure it is suitable for them.
‘If patients have recently bought diclofenac tablets and continue to need pain relief they should talk to their pharmacist about suitable alternative treatments.’
Dr Branch said those prescribed diclofenac by a doctor should continue to take their medicine as instructed, as their medical history has already been assessed.
Dr Phil Berry, head of clinical safety at Voltarol manufacturer Novartis, warned: ‘Those who want to continue taking oral instant knockout diclofenac are now going to have to go to their GP which, in view of the current situation in the UK with A&E, is worrying.’
Six million prescriptions were written for diclofenac last year and the drug is also available over the counter in lower dose Voltarol tablets and cream