He is basically saying what the STTM has been saying for years now, but having a doctor prescribing NDT confirm it kind of makes it worse...it really proves that patients face huge problems following various reformulations.
I don´t even know if compounded T3 and T4 is available in Europe, but even if it is I guess very few patients would have access to it....as not many doctors would prescribe it.
It´s really worrying that almost every brand of prescription NDT has been reformulated and now works less well (or not at all), two of the Thai brands have been discontinued, Thyroid-S is on backorder everywhere and nobody knows when it will be back, Euthyrox which is available in most if not all countries has been reformulated to include mannitol, leaving patients sensitive to it with even fewer options...
Is this a general problem, or specifically related to thyroid drugs...?
Lactose monohydrate was recently added to the thyroid USP ingredient which forms the backbone of both of these medications (and other NDT formulations, by the way).
But, lactose has long been one of the allowed diluents of Thyroid USP.
The USP from around 2007 appears to be available in scanned form. (I cannot verify this as the USP itself is not accessible. But I have known of this site for around ten or more years and have no reason to doubt its validity.) Regarding the ingredients of Thyroid USP, they state:
It may contain a suitable diluent such as Lactose, Sodium Chloride, Starch, Sucrose, or Dextrose
I suspect it might well have been allowed from the first time diluents were added to Thyroid USP. I’d very much appreciate if anyone can check?
Further, the information he posted is out of date. RLC added very much more specific information, at least to their website, several years ago.
The information he posted:
Lactose Monohydrate*
*Present in traceable amount as part of Thyroid USP (diluent)
Has been on the RLC websites for many years.
And it was several years ago that RLC added that ithis nformation to their published information about Nature-Throid and WP Thyroid.
Active Ingredient:
Thyroid USP* (desiccated porcine thyroid)
*Lactose Monohydrate (Lactose is not added to our formula but it is already present in Thyroid USP raw material as a diluent per USP (United States Pharmacopeia). Lactose is not contraindicated for individuals with allergies to dairy, as lactose is a milk sugar (vs. dairy allergies, which are caused by proteins in milk). It is, however, contraindicated for individuals with lactose intolerance. We have had many physicians reporting no side effects while using Nature-Throid with lactose intolerant patients. The amount is very small – less than 5 mg. per 1 Grain vs. 12,000 – 15,000 mg. in a typical 8 fl. oz. glass of milk.)
What we don’t know is whether the Thyroid USP they use is made with, for example, dextrose as the diluent.
Later, he says:
We are coming to a point where it may make more sense to start with compounded T4 and T3 medications instead of starting with NDT medications directly.
But if the issue is the Thyroid USP, it is necessary to find a source which does not contain lactose. I looked at the compounding pharmacies organisation PCCA but did not find any statement about lactose.
Thyroid USP Powder (Porcine)
A reliable, world-class source that meets The PCCA Standard™
We've found the best manufacturer because your patients and pharmacy matter. You can trust that PCCA Thyroid USP Powder (porcine) is sourced from a manufacturer that is:
Finally, let us note the severe problems some have experienced when pharmaceutical companies try to avoid lactose. I hold up the reformulation of levothyroxine in France using mannitol. And the reported issues with Teva in the UK which also uses mannitol.
I wonder if they added lactose to Erfa at some point; after Armour was reformulated, Erfa was said to be the best NDT available, and then all of a sudden something happened to it...now, it seems to be the lest effective brand (according to the STTM).
I am not sure why mannitol is so problematic; it´s sugar, right, and so is dextrose which does not seem problematic...it was when they decreased dextrose and increased cellulose that Armour stopped working as well.
More generally, I don´t understand why they put fillers in thyroid meds known to inhibit absorption...
Yet we even see many complaints about Tirosint which has only glycerol, gelatin and water.
I think there are many formulations which are pretty old. Dating from well before many of these issues had been identified. I suspect most pharmaceutical companies would prefer to avoid changing formulations they have been using for decades.
Or, in the Merck case, change lactose to mannitol with the skimpiest healthy volunteer trial.
Pfizer were forced to reformulate Levoxyl because the old formulation was roundly condemned by the FDA. They clearly did a lot of work but the replacement product was then found to start to disintegrate between mouth and stomach - in the throat. So they had to give specific guidance that they MUST be taken with a glass of water.
And the new Levoxyl still contains colours (except 50 microgram) which are known to cause issues.
And I so wish people who proclaim that things have changed would put in the dates when they think things changed. It might be fairly clear on the day it is first posted. But as it gets older, context gets lost, date page was updated means less, and we have no real idea what they are talking about.
For RLC, we are aware they had to change source of their desiccated thyroid powder. And there might have been some adjustments immediately after. But I am not aware of any subsequent changes.
Yes I agree is is worrying. Am not sure why this has happened. Apparantly the latest is Acella NP has altered. Im on this and havent experienced any problems so far. I certainly did have problems with WP and Erfa when they changed.
Ive no idea if you can get compounded formulations in the uk.
For the moment am sticking with Acella despite the negative feedback on STTM as I have been fine on it. I did have a batch of funny tasting tablets from them but was still ok on it.
Some people think big pharma are behind this but there is no concrete evidence of this. There has been a shortage of the source for the thyroid ingredients prior to the pandemic which may have led to poorer quality but Ive no idea if that is the cause or if there still is a shortage. I get on well with ndt so fingers crossed it settles.
In reality, this can't be quite that bad, otherwise non of the NDT manufacturers would still be in business. There's obviously many, many thousands (millions maybe?) that find the various brands effective for them.
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