There is so much talk of issues with NDT. And I have already written one post about it. I hope to be a sobering voice. I see a lot of stress and worry created, especially in the US. We take it more easy here in Europe.
Is there any need for worry? No, you don’t need to worry. Only people who do not know anything about their optimal levels, or how to monitor them, need to worry. You will learn how to do these things, if you don’t already know it. I will teach you. Follow your temperature and pulse, guide below. Then you just adjust your dose as needed.
Because thyroid meds will continue to fluctuate also in the future. And not only NDT, synthetic meds differ in their hormone levels as well. There is just now, August 2021, a new study on Levothyroxine. Where the authors think the medicine is so inconsistent, it should be put to bed. You can read more about that here.
USP standard for NDT
Synthetic T4 meds like Synthroid and Levo, are legally allowed to vary between 95 and 105 % of the given amount. So your current batch can be 10 % stronger or weaker than your previous batch. NDT and synthetic T3 medicine is allowed to vary between 90 and 110 %, US pharmacopia.
Recall of NT and WP 2020 and NP Acella nov 2020
The recall of Nature Throid and Westhroid in 2020 was NDT that might contain 87 % of the given amount. That is 3 % less than what is allowed. OMG! In hormone content, that would be hardly anything. The same with the NP recall in November 2020. That was also a sub potency at 87%.
The FDA asked RCL labs to recall 6 lots . They tested 10 lots and found 6 to be subpotent, and writes that “some may be subpotent at 87%”, link to FDA recall . And criticized RCL for lack of procedures.
But RCL labs recalled all 483 lots from all over the world. I said at the time, now Nature Throid will no longer be an affordable option. And we see now, that I was unfortunately right. It’s us patients who will pay the price of course. That was a very bad judgement call on behalf of RCL labs. I am thinking, with all the negativity going around in the US, originating from the STTM, they are maybe nervous. Why not just go out and say, all of these lots may be a little sub potent, please check your levels and adjust dose? There is a real shortage of NDT raw material in the world, due to the African swine fever. Can we afford to destroy large amounts of NDT? The NDT certainly becomes more and more expensive as a result.
NP Acella recall summer 2020
And last summer (2020), NP Acella recalled product due to what they called “super potency”, it could contain 115 % T3 of given amount. That is 5 % over the allowed amount. Super potent? It would make for 1 to 1,5 mcg more T3 pr 60 mg, which normally contains 9 mcg T3. Most people would hardly notice such an increase. NP Acella warns, this could be dangerous to pregnant women. BS, is all I can say.
It becomes a big drama. I know people who took NT from the recalled lots. They noticed no difference.
This is the world we live in, all thyroid meds vary in hormone content. I am not saying this is good, and that we should just accept it. But I don’t know how easy it is to rectify it. Not even for the synthetic meds. If you have a look at the study on Levo that I link to over, you see, that the authors highlight detoriation that takes place in Levo that the FDA tests cannot detect. And that make it inconsistent, and even reactive. Maybe this is why so many of us have serious side effects on Levo?
And I believe, making and testing NDT is even more difficult. And keep in mind, each liquid chromatography can cost 3000 US dollars. WE will be the ones paying for increased testing. You can read more about how NDT is made and tested here
But, of course, the manufactures must have quality procedures in place. No doubt about that. Both RCL labs and Acella need to do better. Both synthetic and organic thyroid meds need to be more consistent.