Brand Switch of Levothyroxine: Having an issue... - Thyroid UK

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Brand Switch of Levothyroxine

jacjlc profile image
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Having an issue with my husband. He has been on thyroid medicine for almost 9 months. It was raised from 25 to 50 mcg after 3 months. Blood work was taken about a month ago and his numbers were much better so dosage was left at 50 mcg. He has hypothyroidism and we are in the US . He is 72 1/2 years old, works about 41 hours a week lifting and loading vehicles with stones, mulch, etc. About three weeks ago his medicine was refilled and it was a different brand. Since he has started taking this new brand, virtually immediately, he has been achy, stiff sore shoulders, hips, knees and I was wondering if it could be caused by the switch in brands of Levothyroxine. I have read on this site that you shouldn't switch brands and I am wondering if all the achy stiffness he is experiencing could be from the different brand switch. The pharmacy quit carrying the original brand and we didn't know until after he started taking it. I would appreciate any insight this community can shed on our situation as he has always worked a physical job since he was 8 years old and he is having a hard time with the pain and stiffness. Thank you for any help you can give. Julie

For clarification, the brand he was switched to is a generic as his original was also. Original was Mylan and the new one is Lupin, again in the USA. He had no symptoms other than thyroid numbers fluctuating between slightly high numbers to normal to really high numbers for a while before being put on medication about seven months ago, not nine. In researching, I have found that his symptoms, that started all of a sudden, are symptoms he chould of had in the beginning of our hypothyroid journey. Other than his numbers from blood tests going up and down and back up, he had no physical symptoms of hypothyroidism. Now it is as though he had never been treated, if you read symptoms of this. All his numbers on his tests result were good, in normal range, as they should be, which is why the dosage was left the same. His medication is prescribed in 3 months increments. Sorry if I am confusing, just need to know if this could be his problem. Thanks!

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jacjlc
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20 Replies

That is just a starter dose he needs an increase of 25mg

What were these “normal” ranges?

greygoose profile image
greygoose

No, you are not confusing, and yes this could very well be the root of his problem. And it's something that doctors and pharmacists have yet to get their heads round!

They will tell you that all brands are the same. But that's not strictly true. The active ingredient - Levothyroxine - is always exactly the same but what changes are the fillers and excipients. The amount of levo in the pill is so tiny that you have to have fillers to be able to make a decent sized pill, and different companies use different fillers. And not all fillers suit all people. Many, many hypos have trouble when changing brands. It's well-known amongst the patient community. But doctors and pharmacists refuse to accept that it's true because it doesn't suit them.

Can you possibly find a pharmacy that does carry the brand he gets on well with and take your custom there? I don't know how this works in the US, but you can do that in the UK, and that's what a lot of people have to do to be well, I'm afraid.

jacjlc profile image
jacjlc in reply togreygoose

Thanks for your help. I spent today calling pharmacies trying to find it and unable to do so. We can switch pharmacies, however, no one has any Mylan, the kind he was doing well on. Was told there was a recall a few months ago and read Mylan and Pfizer merged and became Viatris, so other than getting levo in a brand other than Lupin, I don't know what to do. I'm going to try and find a way to contact Viatris and see if they can help point me in the direction he should go. That's another brand to experiment with, if I can find answers. Thank you for all the valuable info on these 2 brands, it will be helpful in finding a new brand. Again my thanks!

helvella profile image
helvellaAdministrator

I agree with greygoose and have listed the excipients (inactive ingredients) below.

They do not state quantities anywhere. But, at a guess, Lupin will contain more mannitol than Mylan simply on the (questionable/guess) basis that it also contains sucrose - and mannitol has been a problem excipient in Merck and Teva levothyroxine products in other countries.

The colouring agents vary by tablet dosage.

Mylan:

BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)

SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)

MAGNESIUM STEARATE (UNII: 70097M6I30)

MANNITOL (UNII: 3OWL53L36A)

MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

POVIDONE K30 (UNII: U725QWY32X)

SODIUM LAURYL SULFATE (UNII: 368GB5141J)

SUCROSE (UNII: C151H8M554)

FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

dailymed.nlm.nih.gov/dailym...

Lupin:

CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

MAGNESIUM STEARATE (UNII: 70097M6I30)

MANNITOL (UNII: 3OWL53L36A)

SODIUM BICARBONATE (UNII: 8MDF5V39QO)

STARCH, CORN (UNII: O8232NY3SJ)

dailymed.nlm.nih.gov/dailym...

If you think it is the change of product, please put in an adverse reaction report:

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

fda.gov/safety/medwatch-fda...

However, as we start taking levothyroxine our own production of the hormones often reduces. When he started taking 50, that was enough to cover the gap between what he needed and what his own thyroid was producing. But if his own thyroid then slowly reduced output, then the gap would increase again - and 50 might well not compensate.

Therefore he might well need a dose increase. And three months might be too long to leave from the previous increase.

Being within normal range is far from acceptable. The ranges are far too wide for individuals.

I urge you to get hold of the actual numeric results - and the reference intervals (ranges) - and add them to this post.

This is a link to a very good article in the British Medical Journal discussing what the 'normal range' really is. Very readable.

The normal range: it is not normal and it is not a range

This blog has the abstract of this paper plus link to the original full paper. Also includes some extra links to a video and some other related information.

Last updated 17/11/2024

helvella.blogspot.com/p/the...

jacjlc profile image
jacjlc in reply tohelvella

Thanks so much for your information on these 2 brands. I spent today calling pharmacies looking for Mylan to no avail. Was told there was a recall a few months ago on Mylan levo and read where Mylan and Pfizer merged and became Viatris. I am going to try and find a way to contact them and hope for info on a brand to put him on, maybe they changed the name from Mylan?, who knows. Your response will hopefully, give me information to maybe prevent to much of an experiment on yet another brand for him. Thank you!

helvella profile image
helvellaAdministrator in reply tojacjlc

Trouble is, the pharma industry is so complex that it is hard to work out anything!

I *think* that Mylan merged with the Pfizer subsidiary Upjohn to form Viatris. But Pfizer and Viatris are separate companies - despite Pfizer owning a substantial shareholding!

Hence, Pfizer still produce their Levoxyl under their King Pharmaceuticals wholly-owned subsidiary while Viatris produce their levothyroxine which is shown under Mylan in the FDA's Orange Book!

accessdata.fda.gov/scripts/...

Sparklingsunshine profile image
Sparklingsunshine

I know that doctors are cautious about putting older people on too much Levo too quickly but 50mcg dose for an active working man seems like a very low dose too me. Its probably enough to shut down his own thyroid production but not enough to replace what he's used to.

Yes the brand change could very well be responsible for some of his symptoms but it could also be that he's simply not on enough thyroid replacement and his body is protesting.

jacjlc profile image
jacjlc in reply toSparklingsunshine

Thank you for your help, I'm thinking this dose is small as well. TSH went from 10.86 in July to 4.43 at the end of November. FT4 - 1.1 and FT3. - 3.1. Antibodies are not good, thyrogobulin 1000 and peroxidase 49, doctor said his thyroid is going to eventually burn out. I don't have a lot of info about those and that was his response. B12 and everything are good. Thanks again!

Sparklingsunshine profile image
Sparklingsunshine in reply tojacjlc

A TSH of 4.43 on Levo is much too high, needs to be lower, sometimes less than 1. He needs a dose increase.

SlowDragon profile image
SlowDragonAmbassador

so he’s been roughly 6 months on only 50mcg Levo?

Levothyroxine doesn’t “top up” your own thyroid output…..instead it replaces it

He’s likely ready for next dose increase in Levo

Suggest you get new blood tests after 6-8 weeks on this brand of levothyroxine

Recommended that all thyroid blood tests early morning, ideally just before 9am, only drink water between waking and test and last dose levothyroxine 24 hours before test

This gives highest TSH, lowest FT4 and most consistent results. (Patient to patient tip)

For full Thyroid evaluation he needs TSH, FT4 and FT3 tested

Also both TPO and TG thyroid antibodies tested at least once to see if hypothyroidism is autoimmune

Has he had thyroid antibodies tested?

About 90% of primary hypothyroidism is autoimmune thyroid disease, usually diagnosed by high TPO and/or high TG thyroid antibodies

Autoimmune thyroid disease with goitre is Hashimoto’s

Autoimmune thyroid disease without goitre is Ord’s thyroiditis.

Both are autoimmune and generally called Hashimoto’s.

Significant minority of Hashimoto’s patients only have high TG antibodies (thyroglobulin)

Very important to test vitamin D, folate, ferritin and B12 at least once year minimum

Low vitamin levels are extremely common when hypothyroid, especially with autoimmune thyroid disease, or when left on too low a dose of levothyroxine

Low vitamin levels also more common as we get older

jacjlc profile image
jacjlc in reply toSlowDragon

Yes his antibodies were tested and it's not good. Doctor said his thyroid is just going to eventually burn out when I asked about them, as I don't have much info about those. Thyrogobulin 1000 and peroxidase 49. He does not have a goiter, ultrasound done and no cancer detected. His Tsh went from 10.86 in July 2024 to 4.43 end of November 2024, down more than half, which I guess is why he said 50 mcg dose shouldn't change. They keep saying, every three months, but I'm going to try and get him in soon since he's not doing well. Getting a new doctor, regular one left the state for family health issues, so not sure how much luck I'll have. His FT4 1.1 and FT3 3.1, B12 and others good. Been busy trying to find his medicine most of the day, my apologies for not responding sooner. Thank you for your help and everyone else. Thank you!

SlowDragon profile image
SlowDragonAmbassador in reply tojacjlc

So high antibodies confirms cause is autoimmune thyroid disease also called Hashimoto’s

His Tsh went from 10.86 in July 2024 to 4.43 end of November 2024

His FT4 1.1 and FT3 3.1,

please add ranges on these results

Was test early morning and last dose levothyroxine 24 hours before test

With TSH over 2 he should have next dose increase to 75mcg and retest again in another 2-3 months

The aim of Levo is to maintain Ft4 and Ft3 at least 60% through range this will usually bring TSH down around or below 1

Please add actual vitamin results and ranges

Even if we frequently start on only 50mcg, most people need to increase levothyroxine dose slowly upwards in 25mcg steps (retesting 6-8 weeks after each increase) until eventually on, or somewhere near full replacement dose (typically 1.6mcg levothyroxine per kilo of your weight per day)

cks.nice.org.uk/topics/hypo...

bnf.nice.org.uk/drugs/levot...

nhs.uk/medicines/levothyrox...

Adults usually start with a dose between 50 micrograms and 100 micrograms taken once a day. This may be increased gradually over a few weeks to between 100 micrograms and 200 micrograms taken once a day.

Some people need a bit less than guidelines, some a bit more

TSH should be under 2 as an absolute maximum when on levothyroxine

gponline.com/endocrinology-...

Graph showing median TSH in healthy population is 1-1.5

web.archive.org/web/2004060...

Comprehensive list of references for needing LOW TSH on levothyroxine

healthunlocked.com/thyroidu....

onlinelibrary.wiley.com/doi...

If symptoms of hypothyroidism persist despite normalisation of TSH, the dose of levothyroxine can be titrated further to place the TSH in the lower part of the reference range or even slightly below (i.e., TSH: 0.1–2.0 mU/L), but avoiding TSH < 0.1 mU/L. Use of alternate day dosing of different levothyroxine strengths may be needed to achieve this (e.g., 100 mcg for 4 days; 125 mcg for 3 days weekly).

sciencedirect.com/science/a...

The optimal daily dose in overt hypothyroidism is 1·5–1·8 μg per kg of bodyweight, rounded to the nearest 25 μg.

jacjlc profile image
jacjlc in reply toSlowDragon

I'm sorry I didn't put everything from July, so here they are: July 2024 - November 24 Thyrogobulin 1000 no change, peroxidase 100 in July and 49 in November, TSH 10.86 in July and 4.43 in November, FT4 - 0.9 in July and 4.43 in November, FT3 3.2 and 3.1 in November. The test was taken 24 hours after last dose and first thing in the morning. Hope this helps, I'll find test results on vitamins as they don't do this everytime. They didn't do them in July or November, although I always tell them. Since he is having issues on this brand of levo (Lupin), I'm going to be try to get him in early as his appointment isn't till end of February or beginning of March. Thanks!

SlowDragon profile image
SlowDragonAmbassador in reply tojacjlc

FT4 - 0.9 in July

4.43 in November,

FT3 3.2 and 3.1 in November.

What’s the range on these (figures in brackets after each result)

Different labs have different ranges

Aiming for Ft4 and Ft3 at least 60-70% through range

Here’s the calculator for working % out

thyroid.chingkerrs.online/?...

I'm going to be try to get him in early as his appointment isn't till end of February or beginning of March. Thanks!

With TSH over 2 he needs immediate dose increase in Levo

Initially adding 12.5mcg for 4-6 weeks before increasing again by further 12.5mcg

Retest 2-3 months after being on 75mcg daily

Approximately how much does he weigh, likely to need further increases over coming year

jacjlc profile image
jacjlc in reply toSlowDragon

Thyrogobulin range - < or = 1 IU/ml his is 1000. Peroxidase <9 IU/ml his is 49. TSH 0.40 - 4.50 mIU/L his 4.43. T4FREE 0.8-1.8 ng/dl his is 1.1. T3FREE 2.3-4.2 pg/ml his is 3.1. I apologize for misunderstanding what you wanted. Thanks for your help.

SlowDragon profile image
SlowDragonAmbassador in reply tojacjlc

so high thyroid antibodies confirms cause of his hypothyroidism is autoimmune thyroid disease also called Hashimoto’s

Free T4 (fT4) 1.1 pmol/L (0.8 - 1.8)

Ft4 is only 30.0% through range clearly showing he is in need of next dose increase in Levo

Free T3 (fT3) 3.1 pmol/L (2.3 - 4.2) 42.1%

Was test early morning and last dose Levo 24 hours before test

most people when adequately treated on just levothyroxine will need dose Levo high enough to bring Ft4 up to at least 60% through range

Dose is increased SLOWLY upwards

Usually increase is 25mcg steps, but looking at his age …..may want to initially only increase by 12.5mcg for 6-8 weeks

Then, assuming ok, increase again by another 12.5mcg so then taking 75mcg daily

Retest thyroid levels in 8-10 weeks after being on 75mcg daily

May need further increase in dose after that

approx how much does he weigh

jacjlc profile image
jacjlc in reply toSlowDragon

We supplement him with B12, magnesium. Can't find an iron or ferritin on his panel, never seen a ferritin category on any blood test but we've had iron. Don't know if they're the same thing but seems to be. I suffered from iron defeinceny, anemia, first several decades of my life and I take B12 injections for PA for past few decades. His folate in April was 16.3 ng/ml from range of 3.4 - 5.4 normal. His B12 was high at 1251 range of 200-1100 pg/ml, but he forgot to stop taking before blood work. For his age alone, he should be 1000 and he weighs approximately 177-180 pounds. I'm hoping to get ferritin and magnesium done next blood work, I've asked before but it wasn't ordered.

SlowDragon profile image
SlowDragonAmbassador in reply tojacjlc

180 pounds = approximately 80 kilo

So he’s likely to eventually be on something between 100-125mcg daily

SlowDragon profile image
SlowDragonAmbassador in reply tojacjlc

Ferritin is storage form of iron

It’s possible to have low ferritin but high iron or vice versa

SlowDragon profile image
SlowDragonAmbassador in reply tojacjlc

Request his doctor test vitamin D, folate, ferritin and B12

You will need to maintain these at GOOD levels on levothyroxine

Many thyroid patients need to supplement vitamin D, magnesium and vitamin B complex

He also needs coeliac blood test

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