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Drug manufacturing  

First-line treatment for bipolar disorder Priadel to be discontinued in UK from April 2021

The planned discontinuation of first-line bipolar disorder treatment Priadel has caused concern that some patients could relapse and face hospitalisation.

priadel tablets

Source: DR P. MARAZZI / SCIENCE PHOTO LIBRARY

UK supplies of Priadel 200mg and 400mg modified-release tablets are expected to be exhausted by April 2021

The manufacturer of first-line bipolar disorder treatment Priadel is discontinuing production of the medicine, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced — causing concerns that patients could relapse and face hospital admission.

supply disruption alert (SDA) issued by the MHRA on 21 August 2020 said Essential Pharma Ltd will be discontinuing production of both Priadel 200mg and 400mg modified-release tablets in the UK, with supplies expected to be exhausted by April 2021.

Priadel is a lithium carbonate medicine prescribed for use in bipolar disorder, as well as treatment of recurrent depression and aggressive or self-harming behaviour. Some 757,323 items of both strengths of Priadel were prescribed in the 12 months between June 2019 and May 2020.

This far exceeds the prescribing of alternate brands, with 11,519 items of Camcolit (Essential Pharma) 400mg modified-release tablets, 11,586 items of Essential Pharma’s generic lithium carbonate 250mg tablet and 3,170 items of Liskonum (Teofarma) 450mg modified-release tablets prescribed in the same 12-month period.

The alert advises prescribers to switch patients to one of these available alternate brands at the nearest equivalent dose.

However, the MHRA notes that clinical advice is “that patients must be maintained on the same brand of lithium to ensure that a consistent serum lithium level is maintained.

“The switching of brands necessitated by this SDA will require individualised determination of dose, close monitoring of serum lithium levels and vigilance for relapse and tolerability in all cases.”

All patients whose medication is switched should have individualised management plans, the MHRA alert said, adding that a brand switch “requires the same precautions as an initiation of treatment” — with particular attention paid to monitoring requirements, including checking lithium levels seven days after the switch.

Asta Prajapati, a consultant pharmacist at Norfolk and Suffolk NHS Foundation Trust, is currently undertaking research into medicines adherence in patients with bipolar disorder.

Prajapati said that if not appropriately managed, “discontinuation of Priadel may risk non-adherence in some patients, leading to relapse and hospitalisation”.

However, he added that the discontinuation “also provides an opportunity for clinicians to review their patients on Priadel, optimise their treatment, ensure they have their ‘lithium treatment pack’ — sometimes known as the lithium purple pack — and counsel patients”.

Patients should “be encouraged to report any changes in their symptoms after switching: e.g. symptoms indicating toxicity or lack of efficacy”, Prajapati continued. Mental health pharmacy teams “have a leading role to play to minimise the impact of Priadel discontinuation on the patient’s outcome”.

He added: “However, we also need to understand that lithium is sometimes used outside of mental health, such as in cluster headache (off licence). In such cases, it may be necessary to refer patients to neurologists.”

The Royal College of Psychiatrists warned in a statement on 3 August 2020 that it was aware that Priadel was expected to be discontinued by the manufacturer.

It said the College is “working with the Department of Health and Social Care and various NHS services to develop relevant guidance for clinicians and patients, and expect this to become available soon”. 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2020.20208290

Readers' comments (9)

  • Why is Priadel being discontinued? Could production be taken over by another manufacturer?

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  • This is a non-problem. Switching products and formulations can unsettle people, especially if the two products are not identical, but this appears not to be the case with Camcolit and Priadel.
    In the 1980s there was competition between Norgine (who made Camcolit) and Delandale (who made Priadel) about which lithium product was the best and which one had the best sustained release. Delandale published brochures with big bold graphs showing what a much better-sustained release Priadel had compared to Camcolit but failed to include the confidence intervals, used a false zero or baseline (trying to enhance the difference), and enlarged just the area they were promoting. However, when looking at the study over 24 hours (rather than just 4hrs) the difference was absolutely minimal and was more wishful thinking rather than statistically significant.
    Bizarrely, the overall outcome was that Priadel 400mg tablets were "sustained release" but had the same release as Camcolit 400mg plain tablets (the comparator in the Priadel study), Camcolit 400mg was then labelled sustained-release too. It wasn't, but if the release was identical to the so-called 'sustained release tablet', it must be too. However, the 250mg tablets were not in the comparison so were left as plain tablets. BUT the 250mg and 400mg tablets are made using the same process and ingredients! Thus, if the 400mg is SR, then so is the 250mg, despite what the labelling says.
    In fact, neither are actually sustained release. Both of the brands of 400mg tablets may have a slightly delayed release, which may slightly reduce the peak levels, but the studies did NOT show a sustained release.
    That was all about 35 years ago so we don't know what has changed since then but the tablets still look exactly the same so I suspect that nothing has changed in the manufacturing process. When I worked in Bristol in the 1980s we actively switched everyone over to Camcolit from Priadel with absolutely no problems.
    As Mr Prajapati works for NSFT, which has a lithium database monitoring the blood levels of everyone in Norfolk taking lithium, perhaps he could use the resources on his doorstep to research any consequences from the change?
    The MHRA advice is based on now discredited historical advice and is obsolete. You do NOT need to switch to Camcolit as if starting from new. That would involve major and sudden drops in plasma levels, which have been shown to be FAR MORE DANGEROUS (e.g. n = 94, Perlis et al, Am J Psychiatry 2002;159:1155–9) than just switching.
    My advice to a service user if they have to switch from Priadel to Camcolit is:
    1. Take the tablets and dose exactly as you did before
    2. Have a blood test before you switch, then another one a few weeks after switching.
    3. Make sure that you have the blood test at exactly the same each time e.g. when you take the tablet (best at night), then the blood test at the same time of the next day as last time. As long as it is more than 12 hours since the last dose that is fine, but you must be consistent (if one test is done 10 hours after a dose and then the next test is 20 hours after a dose, there would be differences in blood levels just because during that extra 10 hours the blood level will fall). [NB The difference between 12hrs and 18hrs post-dose is only about 0.1mmol/L]
    4. Be aware of any changes in how you feel or if you're getting more side effects or less effect. Having said that, the chances really are remote that this could happen.
    5. Contact your doctor or mental health team if you have any problems.
    Stephen Bazire, see also the Choice and Medication website.

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  • Production can be taken over by another Pharmaceutical manufacturer but the problem is that they would need to " BUY" the product Licence and then go through all the processes that MHRA require to prove that the product they have produce is therapeutically Bio- equivalent to Priadel. The problem is Getting the product licence not the production.
    I have come across in 38 years as Pharmacist.
    The negotiators have no idea how to deal with the problem.
    The perception is that they are experts but in reality they have know nothing.
    This partially accounts for why NHS is struggling

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  • Can anyone provide feedback to why Priadel is to be discontinued in early March 2020.

    I am a service user. My mh for nearly 2 yrs has been relatively stable.
    I make good lifestyle choices.
    Priadel has been a constant in this stable period.
    I was told of my local pharmacist that these meds would be discontinued early next year.

    Clearly i am anxious here. I currently take 1200mg lithium ( Priadel - slow release ) + other meds on a nightly basis.
    Is there another make of lithium carbonate that would be an ideal replacement if possible.

    I have made significant progress recently including keeping my weight in balance / mh in balance and hope to continue to move forward.
    I guess i have anxiety and uncertainty about these meds discontinuing early next year and the possible input it could have on my overall health and wellbeing.

    Hope the above overview provides abit of depth to my own situation.

    Feedback on the above would be much appreciated only when time permits.

    Many Thanks

    Andrew

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  • Priadel does 750,000 prescriptions per year in Uk compared to about 12,000 for Camcolit. Either the French manufacturer has lost a thirst for a good profit making product or there's some other insane reason for quitting like Brexit. I've been on it 35 years and free of psyche ward, so I'm looking forward to this cutoff.

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  • I have used Priadel for 27 years and it has kept me stable and in good shape.
    This change is unsettling. Good advice is welcome. Thanks.

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  • I have taken Priadel for 16 years and now have CKD. I have started to reduce from 800mg as a result, now successfully down to 400mg. Feel really good, obviously alongside lifestyle changes. I have felt on a promising path, but now it's uncertain.
    Why is it being withdrawn? Is it because of toxicity? What are other best options? Any advice very welcome.

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  • The drug company has not indicated to date why Priadel is being withdrawn. There has been no mention of toxicity or medicine safety as the rationale for the discontinuation so remain puzzled about this decision.

    I would like to reassure the service users established on Priadel who have indicated in their posts their anxiety at the discontinuation proposal not to panic. Plans are currently being developed locally to support GPs /mental health providers with switching to alternative lithium brands Liskonium or Camcolit.
    Priadel is expected to be discontinued April 2021 so there is sufficient time to make required changes.
    Action:
    Do not panic
    Continue taking your Priadel as prescribed whilst waiting further instructions from your GP/mental health provider on how the switching process will occur.
    If you have further queries or concerns please do contact your GP/local mental health team.

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  • I have been on lithium (priadel) for 7 years. And it changed my life so I understand the panic people are feeling. But I have researched the second commenter, Stephen Bazire, above how lays out a solution, if in a very clinical way. He is respected in this field. So I (and I suggest others do) with be taking this info to my mental health team to discuss. Forewarned is forearmed. And I, personally now feel better that there is a possible solution. Good mental health people.

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