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Diclofenac tablets reclassified as POM

The MHRA says its Commission on Human Medicines decided that the risk of heart problems "could not be ruled out"

The NSAID can no longer be purchased over the counter due to a small risk of "serious cardiac side effects", says the MHRA

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.

 

 
 
What do you think of the reclassification? 

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17 Comments

Stephen Griffiths, Community pharmacist

I agree with others that the 25mg dose was never going to be much use anyway, and with Ibuprofen at a 400mg dose being both a cheaper and probably more effective option, it's return to POM status is not a great loss anyway. I also note that many hospitals have removed it from their formularies in favour of Naproxen. PS. This is a British site, so why do we have the date a**e about face in the American fashion?

David J.A. Robertson, Other pharmacist

Pharmacists only seem to initially handle P medicines to see if they are safe enough for supermarket sales as GSL.

Pharmacy HLP, Manager

Don't worry you can still probably get them of the interweb thingy......

Amal England, Public Relations

I think this is a narrow minded knee jerk reaction on the part of CHM/MHRA- organisations biased towards doctors. Further, the deputy director has failed to recognise that all to often it is pharmacists who highlight this risk to doctors, that have prescribed diclofenac to an at risk patient. A backward move sinfully executed.

Hayley Johnson, Community pharmacist

Whether it is or isn't, the fact of the matter is that the products shouldn't have been on the shelves in the first place. I'd accept this argument a whole lot more if the OTC product were 50mg.

N O, Pharmaceutical Adviser

Why is there so much noise for this particular switch?? I always believed (and will still say) that the low dose available over the counter would never have been really effective for conditions that are advertised, yes see the advert and you will think that kind of a pain needs at least 2X50mg, for the kind of price people pay !!! Why make such a cry when we still have Ibuprofen, which is as good or better to diclofenac for the conditions we treat over the counter. In my opinion, whether there is risk of CV events or not, the 25mg tab was never a wise idea to be approved in the first place.

Michael Stewart, Community pharmacist

N O - for me it is the prinical rather than the specific drug or dose. We are experts in medicines and managing risk - why are we not trusted to manage this? How many other medicines could have their P licences revoked over a small increase in risk for a small subset of population?

Hayley Johnson, Community pharmacist

If we are experts in medicines, why are we accepting nonsense OTC products onto our shelves in the first place? We constantly demean ourselves as healthcare professionals by stocking this items. We should be loudly shouting that we will only sell evidence based medicine, not micro doses of real medicines, or homeopathy, or irrational cold combinations, or anything like that. We simply can't have it both ways as a profession.

N O, Pharmaceutical Adviser

What kind of principal are you talking about ?? This is not a way to show our expertise in medicines. This strength of Diclofenac should never have been approved for OTC in the first place. I am sure the main reason behind withdrawal of the P status is its efficacy and then the side-effect profile. Unfortunately we have a system here, where the authorities concerned will never accept their mistakes and try to correct it by giving some other reasons when it is too late. The company marketing the stuff has already made millions by this switch, they are not bothered what happens to the Pharmacy or the Pharmacist as a professional. They will come out with some other drug/ formulation and these same Authorities will approve the switch, MARK MY WORDS. If you want to prove the expertise in medicines, then there are many other roles which we can fill to prove this and not just selling a OTC medicine !!

Anthony Cox, Academic pharmacist

It isn't about us as "experts as medicines" but about the suitability of the drug a P medicine. It just isn't suitable at the current time, with our lack of access to patient notes, particularly when there are safer alternatives. As experts in medicines, as soon as it was clear that diclofenac had this problem, we should have been arguing for it becoming a POM medicine (remember there are pharmacists who can prescribe). Pharmacists cannot be advising doctors not to prescribe it (and a good job they have done on this) and on the other hand still be selling it as a P medicine with no note of it in the patient's medical record and no real way the pharmacists can assess CV risk. Doctors do not see every drug withdrawal as a slight against their profession - neither should we. The CHM's primary concern is patient safety, not the fragility of a profession's self-image. We should be strong enough to agree with this decision, based on the clear evidence, and start to agitate for greater access to patient notes and a wider prescribing role.

Michael Stewart, Community pharmacist

I kind of agree Anthony and I'm not personally offended by the decision, but I'm just suggesting that we could have managed this safety risk. If it was a real safety concern then the POM licence would also be revoked. And of course we can determine in the pharmacy if there is any cardiovascular disease or risk factors - just with some simple questioning. Any doubts over safe supply would result in a no-sale. Also I think the cardiovascular risks associated with diclofenac were known before the P med got licenced? Really the question should be then why did MHRA approve the P licence in the first place? Ultimately though I also agree with other posters here - it was a pointless P product in the first place. Personally I have never recommended it due to efficacy issues and cost.

Hayley Johnson, Community pharmacist

I've barely sold any diclofenac tablets OTC anyway. The stupidly small doses and enormous price tags meant patients were better off just taking a decent dose of ibuprofen.

michael mustoe, Community pharmacist

This decision runs contrary to the needs of both our patients and the needs of the NHS. We are healthcare professionals and fully able to manage the risk. We need MORE tools NOT less. More POM to P's, NOT P's to POM's!!! Come on DoH/MHRA, please look at the big picture. An extremely disappointing and short-sighted decision has been reached

Sean Devlin, Locum pharmacist

So now not only are POM-to-P switches slowing down, but P-to-POMs are speeding up! How are we ever going to get the population to embrace self care if the number of available OTC therapies decrease and the MHRA are announcing patients who are actually looking for OTC treatment "should speak to their GP". If any new evidence has come to light regarding diclofenac and cardiovascular risk (I thought the 2013 report stated the CV risks occurred at daily doses over 150mg - that's nearly a packet and a half of Joint-Eze tabs!) then surely the OTC indications for Naproxen should be broadened to serve as a suitable replacement, but then again it does seem the NHS/MHRA/A.N Other refuse to place any trust in community pharmacists with regard to clinical roles no matter how many hours of CPD we clock up a year.

Gerry Diamond, Primary care pharmacist

Diclofenac is a great drug and have always found it effective but I wonder about the value of p medicines as there are so many cotraindications and cautions, that its hardly worth recommending them anyway.

Michael Stewart, Community pharmacist

I feel it is a shame that CHM has taken this decision. There are many medicines available OTC with risks attached. It is our job to manage those risks. Patients at cardiovascular risk are identifiable in the pharmacy simply through the use of 2wham. Counter assistants will know when to refer to the pharmacist. This issue could have been managed by pharmacy, now we have one less drug in our armoury. Is it a slippery slope?

Edward H Rowan, Locum pharmacist

I was just thinking the same. If Diclofenac can go to POM then the same argument will go for Pholcodine or Dextromethorphan, Pseudoephedrine, Codeine (hooray!), Clotrimazole, Hydrocortisone, Mebendazole... If we're not trusted with Domperidone and Diclofenac, can we be trusted with Loperamide? We will end up with POM and GSL and no P category.

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