Hi
My despensing surgery had problems obtaining mercury pharma levothyroxine this month. They rang me last week to say they have managed to get it and today i picked it up and find i have eltroxin.
I thought it was not available here. I am hoping it is the same as the regular levo. By the way i am in dorset.
Foreversummer
The two products (Mercury Pharma Eltroxin and Mercury Pharma levothyroxine) have the same Product Licence numbers at each dosage. So they certainly should be the same.
It is unclear why Concordia International (owners of Mercury Pharma) would re-introduce the Eltroxin brand - just as it was unclear why it was originally withdrawn.
Does the box say Concordia on it? The Patient Information Leaflet?
If there have been production difficulties it seems not impossible that they have released product originally destined for Ireland (or anywhere else it is still sold as Eltroxin). Or has it been imported back from Ireland? Or is their decision to re-introduce the Eltroxin brand behind the apparent shortages we have seen reported recently?
Was Eltroxin ever discontinued? It is still listed in MIMS.
It was never removed as in de-listed. All the documents, including the Electronic Medicines Companion, continued to have Eltroxin-specific entries. Just none made it to market.
Actually, we heard one or two occasions on which Eltroxin did make it to market. Whether this was an accident, redirection of export product, grey or parallel import, well I don't know.
You are quite right. The Product Licence number are the same so I'm relieved about that.
The box and the product info leaflet are exactly the same except for the obvious name change and the dates the PIL was last updated. No mention of Concordia on either just Mercury Pharma. It does say on the box that Eltroxin is a registered trademark of Mercury Pharma Group Limited.
I seem to remember reading here way back that they were originally two different formulations. Difficult to understand why they go to the trouble of doing two identical products with different boxes and PILs. Maybe it's a trademark issue or something - I'm merely guessing.
Just because the product licence number is the same does not mean there won't be any differences. Ask them if they are manufactured in the same factory using exactly the same processes and whether the solvents they are using are exactly the same and in the same proportions. Ask if the bulk materials are stored in the same way for both products. All these things have been proven to make a difference. There are reliable research papers showing the effects on levothyroxine. What does the product licence number actually reassure customers about?
Information about product licensing, doesn't look like it guarantees there is no difference between products, just that the manufacturer who has the licence is entitled to produce them. According to this website the product licence guarantees that the benefits outweigh the risks. That may not be the way patients view it when a product makes them sick and they are under the impression that it is the same product in different packaging because of the licence number.
Eltroxin is available, it was suspended temporarily in 2014. I will submit a Post when I have some time.
I would like to know why Eltroxin was suspended and what the MHRA have done about ensuring it's quality if it's being reintroduced. If there have been any changes we should be informed and so should healthcare professionals. We should also be able to view the patent if anyone knows where it can be found? It was the reference product so that's extremely important with respect to any future patents. What are reformulations or new products being referenced with now?
This document explains amcolimited.com/news/levoth... . Try to ignore all the detail about different versions under product licences (PL) as this is now history. Jump to the bit 'Since early 2013 AMCo'. Eltroxin is now back on the market but you will need to push your pharmacist to order it.
Hi jimh111. The excerpt below from Mercury Pharma makes no sense whatsoever. It tells us nothing. If they could pack more of the generic product and it was exactly the same as the branded product then why not just pack more of the branded product? It's completely nonsensical.
"Since early 2013 AMCo has been experiencing some manufacturing difficulties with levothyroxine tablets (as indeed have other manufacturers). AMCo wanted to make sure that this would not cause a shortage of levothyroxine tablets for UK patients and therefore (after consultation with the MHRA) AMCo temporarily stopped packing the branded (Eltroxin) product under PL 12762/0016, PL 10972/0031 and PL 10972/0032 in order to pack more of the generic (levothyroxine) product under the same license numbers and to produce the generic product under license numbers PL 16201/0001 and 16201/0002. Consequently, your pharmacist may have been unable to get any supply of tablets labelled as Eltroxin since July 2013."
It doesn't reassure me that nothing was changed. If they were packing a lot more products they must have increased their production and that could have affected their bulk storage, the places from which ingredients were sourced and a number of other factors that relate to increased productivity and can affect the degradation of levothryroxine. So instead of improving the levothryxoine quality situation, it could have actually increased the variability of the product with no longer any branded product to act as a reference to reformulated products.
I'd like the MHRA to explain what the reasoning was and what they did to ensure that the quality of the generic was the same as the branded version? How did they monitor it? How did they monitor that increased production didn't affect the stability of the tablets? The yellow card system isn't a good way of monitoring a drug like levothryxoine due to the slow acting nature. Doctors need to be made aware of changes and ensure they monitor any change in patient health even if they are not sure the symptoms are definitely due to the drug, it's only with a body of reported symptoms that it can be confirmed. More than anything patients need stability, choice, quality and more complete information.
They didn't increase production, they recovered from a loss of production due to 'difficulties' whatever that means. I agree there's no reason to stop packing the (same) tablets in 'Eltroxin' packets. The difficulty was with the production of the medication not the packaging. I don't know what the MHRA were up to, it is disgraceful, if they had problems making the tablets they must have had lots of Eltroxin boxes lying around. The quality of the generic and the branded levothyroxine is the same - they are the same tablets, they carry the same PL number.
You might well be right. No matter that they said the products were identical, some members who were on Eltroxin for years said that they'd become unwell on the MP Levo. I, too, found the difference between Eltroxin and levo (improved on Eltroxin and symptomatic on levo).
They said the products were the same but when I contacted them to ask if the solvents they were using were exactly in the same proportions and the manufacuring processes the same they would not reply to me. I submitted a yellow card because I came out in urticaria after the switch. I dont' believe they were identical unless they can give me proof they had made no changes to either their storage methods, solvents and their manufacturing processes all of which are known to affect either the degredation or the dissolution and bioequivalence and bioavailability of the product. Therefore I am not satisfied with the way levothyroxine is being regulated.
Trouble is, if they changed the manufacturing process in some way, as you suggest, it is possible that the same change would have been applied to Eltroxin as well - at least by now.
We do not get full details of the Product Licence and what it allows. So it seems feasible that they continued to be within that even with a change.
My experience is ditto shaws,
I do believe Eltroxin is used in the South of Ireland to this day.
Different Government we are aware of that.
J
Eltroxin, being a Brand name, must have been 'slightly' more expensive to the non-brand levo.
Despite MP stating they were identical we, the patients, know that was untrue.
Exactly, it's quite obvious methinks.
It is down to money, that's well and good, but so much funds are misdirected.
We, the patients have no voices, never had and I doubt if we ever will.
My ' Italian' sister is prescribed a Probiotic at the same time as an antibiotic.
Our GPs ( because of their guidelines) can't do that. So the patients have to get PPI's etc,etc.
This forum would not have thousands and thousands of members if we were getting the correct service.
J
Can you explain exactly what the PL number actually gives authorisation for? For example, on the NHS website it says it gives authorisation to produce a particular tablet and on the MHRA website it says it gives authorisation for a formulation and that the factories are inspected. What is a manufacturer entitled to change without affecting the authorisation? For example, I read one report (I think from New Zealand or Australia) describing how a change in the solvent used to convey the levothryoxine drug into the excipients could affect the bioavailability and dissolution of the medication. Are manufacturers entitled to change this without tellling patients and how would the MHRA know if they changed it? It's not in the final product because it evaporates. How is the authorisation actually monitored?
What an authorisation doesn't seem to control is the production methods for the tablets and the storage of bulk materials for use in the product or after production.
With levothyroxine, this means that the product efficacy could be altered despite the PL number being the same if any of the factors I've mentioned are altered.
Therefore I think it's wholly possible that there was a change between the original Eltroxin and the generic formulation that we as customers were not informed of. If there was a problem with the production of the medication then we and our doctors should have been informed. They should have admitted a problem so that patients could at least have informed their employers and families about the reasons for their ill health during that period of time.
When we had the Teva scandal, the company had substituted one form of dextrin by another. This was later said to have been in contravention of the Product Licence - and the MHRA had not known.
As Product Licences are not public, and seem not to be accessible even with the Freedom of Information Act, not that I have put in a formal request. As they are not accessible, even if manufacturers had to tell of changes, we would have insufficient context to make much sense of it.
I the pl number on my generic is the same as the eltroxin.
The PL 16201/0001 and 16201/0002 tablets were slightly different to the other PL generics (which are identical to Eltroxin). The PL 16201/0001 and 16201/0002 products have now been discontinued. All AMCo generics are now the same as Eltroxin. However, there are other brands. So, if you want Eltroxin you should ask your doctor to prescribe Eltroxin and pester your pharmacist to get it. Also, I don't think there is a guarantee from AMCo that their generics will always be the same as Eltroxin, so insist on Eltroxin. The latest NHS England data shows that Eltroxin is no more expensive than the generics.
What differences can at one and the same time allow products to conform to a specific Product Licence and yet actually be different to each other?
Further, if the products differ, it seems surprising that they are physically identical. This would be especially surprising as both Levothyroxine and Eltroxin Patient Information Leaflets were updated in or around November 2015 to show new markings on the tablets themselves - LT 25, LT 50 or LT 100. Were there to be any need to trace which product someone had, it could not be done from visual evidence.
I would be surprised if, after the fuss about actual differences that resulted in the statement son Mercury Pharma's website a few years ago, the MHRA would allow the products to differ despite having the same Product Licence and physical characteristics.
I can't see how anyone is getting confused. The extract from the AMCo document makes it clear, all Eltroxin tablets have a generic equivalent which is identical. There used to be some AMCo generics with different PL numbers that had "a slight difference in the amount of powdered acacia" - these products are no longer marketed.
"shows that all branded (Eltroxin) products manufactured under a particular PL number are also licensed under the generic name (levothyroxine). These products are identical in every way. For example “Eltroxin 25 microgram tablets” and “Levothyroxine 25 microgram tablets” that bear PL 12762/0016 on the packaging are identical except for the immediate packaging".
Nobody knows what will happen with the generics in the future, so if you want Eltroxin ask your doctor to prescribe Eltroxin.
And if Eltroxin is not available, as had been the case for about three years, your pharmacist may be unwilling to supply Mercury Pharma Levothyroxine - even though it is identical.
Eltroxin is absolutely available. Straight from the horse's mouth:-
Eltroxin tablets (all strengths) are available. Please inform your Pharmacy to contact our wholesaler Alliance Healthcare for ordering of this product. In case your Pharmacy finds any difficulties, they can contact our Customer Service Team on 02085889441.
Eltroxin was not discontinued it was suspended whilst they distributed their remaining supply in the generic form only (I'm not justifying this action). Eltroxin sales are small compared to the generic, so they will clearly want the generic market. Eltroxin is incredibly cheap to manufacture so it makes sense to produce just on tablet and market it as both Eltroxin and generic levothyroxine. I'm not supporting Concordia, just making the point that Eltroxin is available if patients want or need it.
However there are price control mechanisms for branded medicines supplied to the NHS which do not apply to generics. Which I believe is why the Tertroxin product was changed to generic liothyronine - so they could exploit that "loophole".
One interesting feature is that the tablet markings for both Eltroxin and generic levothyroxine from Mercury Pharma have both changed - late 2015. I wondered if that signified a change of some sort to their manufacturing? Hence why they have seen fit to re-introduce Eltroxin. Maybe new machines? Or made in different factory?
What has been odd all the way through was that they continued with Eltroxin branding for Ireland.
The product is still being manufactured in the United Kingdom.
Custom Pharmaceuticals Ltd., Tecore House, Conway Street, Hove, East Sussex BN3 3LW
If you think this is not correct, I suggest you file a report with the MHRA.
Was there ever a difference in appearance between the tablets? (Other than the recent change to tablet markings.)
Eltroxin - Advanz. Pharma 
Eltroxin vsLevothyroxine 
Eltroxin variations.
Eltroxin 
