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Medicines regulation

Risk of heart problems prompts removal of OTC diclofenac from UK pharmacy shelves

UK medicines regulator announces immediate withdrawal of the over-the-counter painkiller.

Oral diclofenac tablets (molecular structure pictured), used for short-term pain relief, will no longer be available as an over-the-counter pharmacy medicine in the UK

Source: / Alamy

Diclofenac is associated with an increased risk of cardiovascular side effects

Oral diclofenac tablets, which are used for short-term pain relief, will no longer be available as an over-the-counter (OTC) pharmacy medicine in the UK from 15 January 2015 because of a small risk of heart problems, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

Diclofenac was switched to a pharmacy (P) medicine in 2008, but in August 2013, the MHRA consulted on whether it should revert to a prescription-only medicine (POM) following a European review that found there was a small but significant increased risk of cardiovascular side effects associated with the drug.

Subsequently, the UK’s Commission on Human Medicines (CHM) looked at the data and concluded that these side effects cannot be ruled out even when diclofenac is taken for a short time or at a lower dose, and advised that it is no longer suitable as a P medicine.

“Out of 1,000 patients allocated to diclofenac, three more major vascular events [were seen] compared to placebo,” says Sarah Branch, the deputy director of vigilance and risk management of medicines at the MHRA.

Non-steroidal anti-inflammatory drugs (NSAIDs) have a long history of cardiovascular safety concerns, highlighted in 2004 with the worldwide withdrawal of Vioxx (rofecoxib), a cyclo-oxygenase-2 (COX-2 selective) NSAID.

“Diclofenac is similar to COX-2s’s small increased risk of cardiovascular events, which has been seen with high doses and long-term duration of treatment, but there are no data to exclude this at lower doses,” says Branch. “In a pharmacy setting, [you] can’t assess the cardiovascular risks of patients wanting to take this product.”

Diclofenac is available as both generic medicines and as a branded product Voltarol (made by Novartis) in two strengths, 25mg and 12.5mg. The MHRA says diclofenac is not as widely used as other OTC NSAIDs.

Sales of OTC oral diclofenac in 2014 were £6.8m in Great Britain, of which the bulk, £6.4m, was Voltarol (52 weeks to 30 November 2014), says Martin Wood, head of strategic insight for retail at IRI UK, which monitors OTC drugs sales.

By comparison, OTC ibuprofen (adult oral analgesics, including ibuprofen plus codeine and other combinations) had sales of £156m over the same period in Great Britain. Voltarol will still have a pharmacy presence as a topical formulation, which had sales of around £31m for the same period.

The Proprietary Association of Great Britain (PAGB), the trade association for OTC drug firms, is disappointed by the decision, saying it reduces consumer choice in non-prescription options for short-term analgesics.

It also believes that pharmacists can manage any risk to patients. “Patient safety is paramount and we believe that pharmacists are well-placed to advise people on whether such products are safe and appropriate to use,” says Matthew Speers, PAGB’s chief executive. “At a time when the NHS is struggling to meet demand with finite resources, taking away an opportunity for people to be independent and get help from the clinical professional on the high street cannot be the best use of scarce resources.”

The manufacturer of Voltarol also disagreed with the decision. “Based on a review of current available evidence, Novartis Consumer Health does not believe that low-dose, short-duration treatment with diclofenac (which is typically available as non-prescription) increases cardiovascular risk compared with other NSAIDs when used as directed.” The benefit-risk profile of oral diclofenac as a non-prescription medicine remains positive, it adds.

Anthony Cox, a lecturer in clinical pharmacy at the University of Birmingham and a member of the Royal Pharmaceutical Society’s English Pharmacy Board, said on Twitter: “The MHRA decision on diclofenac means we have dodged a bullet on the next Which? secret shopper report.” He added: “Shame we weren’t one step ahead of the MHRA and done it ourselves.”

Novartis sells diclofenac as an OTC medicine in 35 countries across the world. These include Germany, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Switzerland, Australia, Benin, Burkina Farso, Cameroon, China, South Africa and Mexico. Diclofenac remains a POM in the United States, Japan and Ireland, according to the Association of the European Self-Medication Industry.

Pharmacists have 48 hours from 14 January 2015 to act on the decision and remove OTC diclofenac tablets from pharmacy shelves. Diclofenac topical gels remain available from pharmacies.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067579

Readers' comments (2)

  • “People with short-term problems will find their options for over-the-counter treatments further reduced. Which is unfortunate as these people are often younger with a lower risk of the cardiovascular side effects of NSAIDs. They may need to consider other NSAIDs such as ibuprofen which has a slightly better safety profile.

    “Those people who are taking diclofenac for the pain caused by long-term problems like osteoarthritis need a pain relief strategy that is safe over longer periods of time. This group are more likely to develop complications due to using NSAIDs because of other health problems and medications that they may be prescribed. As such it is best that medications are prescribed by a doctor rather than bought over the counter. So that the safest painkiller options are considered for that individual and they can be monitored closely for side-effects and other problems.”

    Dr Tom Margham, GP and primary care lead, Arthritis Research UK

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  • I feel I ought to expand on my views about diclofenac, as no doubt they may provoke a letter.

    For a number of years, since the increased risk of cardiovascular events were noted with diclofenac, there has been a major drive to reduce diclofenac prescribing. This has been fairly successful, changing prescribing habits being generally difficult, and has been in large part facilitated by pharmacist prescribing advisors.

    There are, however, some patients who can make the informed choice to use diclofenac, after an informed discussion about the risks and benefits of diclofenac, in the light of the full patient record. This means it does remain as a POM, at present.

    This isn't about the loss of a drug from a profession, but the suitable place for a drug to be placed in the regulatory system designed to prevent harm to patients. With the changes in prescribing, diclofenac will still be available to prescribing pharmacists. There is no suggestion that pharmacists do not have the ability to prescribe diclofenac more dangerously than GPs (in fact, I would expect prescribing pharmacists to be less habituated prescribers of diclofenac).

    This decision is about managing risk in the current OTC environment we find. As a profession we have accepted in the past year that changes are needed in how we deal with OTC sales and currently we do not have access to medical records (we should). On a public health basis, it seems nonsensical to have diclofenac as an OTC drug, when we are policing its use by prescribers who have full access to medical records. I have seen diclofenac on open sale (empty boxes you have to take to the counter) and received inadequate consultation (that did not involve a pharmacist) when I purchase it.

    As experts in medicines, we should be willing to support the movement of medicines from P to POM as much as we are willing to see them moved from POM to P. This should be based on evidence, and a realistic public health view of the OTC environment (rather than an idealistic partisan professional perspective). Over the years, a number of drugs have been withdrawn, or restricted, from the POM category. Although there may have been debates about patient access to these drugs, I have been unaware of medical journal editorials arguing that a drug withdrawal is a slur on the professional skills of doctors.

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