"Mercury Pharma Eltroxin" and "Mercury Pharma Levothryoxine"

[helvella]

There have been many discussions about the differences and availabilities of the two differently-labelled Mercury Pharma products. I recently contacted Advanz Pharma (who own the Mercury Pharma brand) and recieved a reply. I'm posting this as clarification:

Thank you for contacting ADVANZ PHARMA requesting clarification regarding Eltroxin branded and Mercury Pharma branded Levothyroxine marketed in the UK by ADVANZ PHARMA.

As you are aware the products below share the same product license (PL) number, therefore are of the same specification/formulation:

Eltroxin 25mcg tablets (PL 12762/0016)

Levothyroxine 25mcg tablets (PL 12762/0016)

Eltroxin 50mcg tablets (PL 10972/0031)

Levothyroxine 50mcg tablets (PL 10972/0031)

Eltroxin 100mcg tablets (PL 10972/0032)

Levothyroxine 100mcg tablets (PL 10972/0032)

The relevant department have also confirmed that both of the aforementioned products are available.

The generic Levothyroxine tablets are available as a bulk pack and 28 pack size whilst the Eltroxin brand is available only in a 28 pack size.

I hope this makes things clear. Though it is still difficult to properly understand why they continue with two liveries (labelling/packaging) for the same product!

[Lora7again]

Thank you for the information 🙂

[jimh111]

Some doctors prescribe Eltroxin so the pharmacist has to supply Eltroxin. They are covering both markets.

[helvella Administrator in reply to jimh111]

The trouble with that being sometimes Eltroxin-branded product has not been available.

I'd be frustrated as anything to go to a pharmacy and be told they cannot get "my" Eltroxin when they have Mercury Pharma Levothyroxine on the shelf but won't dispense it.

[Nanaedake in reply to helvella]

Are they made in the same factory with the same manufacturing processes because we know that the manufacturing process can affect absorption. Also, are they using the same carriers since the molecular size of the carriers can affect dissolution and as the carriers evaporate during manufacture they are not listed. So, I'd like to hear whether there are any differences at all. When I rang and emailed them them and did a yellow card report after getting a reaction when switched from Eltroxin to Mercury Pharma, they did not respond. This was a few years ago.

[helvella Administrator in reply to Nanaedake]

I cannot tell you any more than the company which, as I quoted, say:

As you are aware the products below share the same product license (PL) number, therefore are of the same specification/formulation.

The are manufactured by the same company. They have the same ingredients. It says that in the Patient Information Leaflet.

I really struggle to imagine the company and the MHRA allowing two different products with the same PL numbers. That are identical to look at. That the company says are identical. Especially as the final step in merging of the products and their PL numbers was (at least partly) a result of complaints and the MHRA were involved at the time.

A while ago, the imprints on the tablets were changed - on both products at exactly the same time. (They now have LT 25, LT 50 and LT 100.)

If there were a product report - how would they identify whether the tablet was one product rather than the other? If the issue needed a recall, they would have to recall both. It would be very confusing all round.

Whatever might once have been the situation, once the PL numbers were merged, and even more certainly when the imprints changed, I think it would be unsupportable for them to differ in any way.

[Nanaedake in reply to helvella]

There seems to be too much left to mystery. The company can declare that the product formulation is the same but as I understand it, that doesn't mean all the chemicals (with the exception of levothyroxine) a used in production are the same or that the percentage of one chemical to the other is the same. I recall reading the report of MHRA investigation into New Zealand levothyroxine that determined some of the potency problems were down to the percentage ratio of 2vof the carriers and also the molecular size of carriers that convey the levothyroxine into the filler material. This means there could be substantial differences that do not need to be declared according to legislative requirements. Therefore, I do not feel confident that the 2 formulations are totally equitable. In any case, I now avoid either formulations as they were not bioequivalent in the past according to my blood test results and the reaction I had when switching. It would be better if there were greater transparency, I feel. Especially when our lives depend on it and T3 and NDT are denied to most patients. I've raised my concerns in various ways but feel like a lone voice. I can't now find the New Zealand reports, they have vanished from the Internet.

[helvella Administrator in reply to Nanaedake]

I accept that two batches of an ingredient might differ. Further, that whatever that difference is, could affect the person taking the medicine.

But I do not believe that they could make a consistent, intentional difference.

We have the experience of the old formulation of Teva where an unauthorised variation of an ingredient caused problems. The end result was the product being withdrawn from the market. Clearly things can and do go wrong.

I can also imagine that failure to positively check the quality of an ingredient could cause problems.

I struggle to imagine Advanz buying a some ingredient and having to decide whether it can be used to make product A or product B depending on whether it passes some tests, or whether it was supplied by company X or company Y, or on any other basis.

I find it far easier to imagine a batch of tablets being made then some put into packaging A, others into packaging B.

I can also see that there might well not be full equivalence between the dosages. That two 25 tablets do not have precisely the same effect as one 50. (And so on with all the possible permutations.)

[Nanaedake in reply to helvella]

Yes, where ingedien ts are concerned I can see that's the case. However, it's not only ingredients that I think could have variations. It's the actual chemicals utilised in manufacture which evaporate and are no longer ingredients where I think differences could exist. The molecular size of solvents may vary according to their source. One source may be limited so other sources may be used for generics. This has been shown to affect dissolution and buoavailability previously so I think it's possible and could account for the differences between brand and generic.

When I read the TEVA reports I understood that levothyroxine was wrongly classified in the BNF and as a result, manufacturers were complying with manufacturing regulations related to its classification but these were unsuitable for levothyroxine s pharmaceutical properties. So, This has been remedied as levothyroxine has been reclassified. However, it demonstrates that manufacturing methods as well as chemicals used in manufacture in addition to fillers used can alter composition, dissolution, bioavailability and bioequivalence. Therefore, I'm very cautious about manufacturer's statements' which are not explicit' about their product and not convinced we are being informed of the whole truth.

At the end of the day though, if a product suits you and maintains your health then these differences are irrelevant. Since levothyroxine is absorped internally, differences in gut function may have a bigger impact in how well a product performs in a given individual and fillers could certainly impact on absorption. I'm not sure enough is known about this.

[RedApple Administrator in reply to Nanaedake]

Nanaedake , Are they made in the same factory with the same manufacturing processes because we know that the manufacturing process can affect absorption. Also, are they using the same carriers since the molecular size of the carriers can affect dissolution and as the carriers evaporate during manufacture they are not listed.

As both Eltroxin and MercuryPharma brands declare on their PILs that they are made by Custom Pharmaceuticals, (who are in Hove UK), I would assume that they are indeed using the same processes, carriers etc. There doesn't seem to be any sensible reason to do otherwise. However, the probability is that only the actual manufacturer can answer such questions, so getting in touch with them might be your best way of getting the answer to your questions.

[Nanaedake in reply to RedApple]

They wouldn't answer my question.

[helvella Administrator in reply to Nanaedake]

You said that was a few years ago. How about asking again?

I guess that a single case of the same batch number being used for both products would demonstrate they are the same. Perhaps people who have Eltroxin could post some batch numbers and then others can check whether they have the generic product with the same batch number.

[Nanaedake in reply to helvella]

Yes, I could try again, however, my question was asked after the pil numbers had been altered to be identical. And they did state that the ingredients were identical. They would not answer my question as to whether the solvents and ratios were identical.

[nightingale-56 in reply to Nanaedake]

Hi Nanaedake I had problems when I was changed from Goldshield Eltroxin in 2010 to Mercury Pharma Generic Levothyroxine, and to date am still suffering (along with my special needs son). Could you please tell me how this affected you.

[Nanaedake in reply to nightingale-56]

It was later than that when I was switched which is relevant because the MHRA review and changes to levothyroxine were after 2012. The problem I had was getting urticaria and rapid heart rate intermittently like tachycardia, I had joint muscle pain but I can't be sure if that was Mercury Pharma or some other reason. I've been fine since switching to a different formulation and I reduced the dose as did not need as much levo on a different formulation. So either absorption is better or they were not exactly the same potency.

I don't have autoimmune thyroid disease so your problems could be entirely different cause than I had with levothyroxine. Everyone is different. All you can do is try a different formulation, see if it helps and eliminate that as a cause.

[jimh111 in reply to helvella]

Yes, I'm aware Eltroxin is often 'not available'.

Decades ago Kodak marketed 'Kodachrome' slide film. A superb product but customers had to pay for processing when they bought the film, they couldn't have it processed cheaper elsewhere. (There are technical reasons for this, the dyes were in the processing not in the film). However, the authorities determined this was anti-competitive and Kodak was instructed to offer Kodachrome without charging for processing. This they did - but they didn't tell anyone, no marketing. There were no sales, Kodak reported nobody wanted this option and they were allowed to continue charging for processing.

The same appears to be happening with Eltroxin, it is frequently 'unavailable' even though it is the same as the freely available generic, just different packaging.

The last time I looked generic levothyroxine was a tiny fraction more expensive than Eltroxin. I suspect they are restricting access to Eltroxin so that sales diminish and they can then drop it and exit price regulation. The way will then be clear for generic levothyroxine to drift up in price.

[helvella Administrator in reply to jimh111]

At present, in the UK, all other levothyroxine tablets are compared against Eltroxin.

If a new product is found to be equivalent, it is well on the way towards approval.

I wonder what would happen to this approach if Eltroxin were to disappear entirely?

I even wonder if the comparison could still be done were the tablets to be generic but have the same PL as Eltroxin? Or would it be regarded as not acceptable?

BNF currently shows prices identical for Eltroxin and other products.

[Ladybex]

I take Mercury Pharma 50mcg after trying 3 others that didn’t agree with me ... thank you for info 👍

[SlowDragon Administrator in reply to Ladybex]

Hasn’t your GP increased dose levothyroxine to 75mcg yet

Previous post shows you need dose increase in levothyroxine

healthunlocked.com/thyroidu...

[Ladybex in reply to SlowDragon]

No I had one consultant tell me to stop taking them and another one said take 50mcg alternate days 🙈

I have a worse problem at the moment ... after MRI scan I found out my brain tumour has come back so waiting to hear from Neurologist.

Guess thyroid takes s back seat atm but thank you for thinking of me 😊