I think Besins might be experimenting with different types and suppliers of Estradiol, and potentially with some of the other carrier ingredients too. Likely due to the massive increase in demand for HRT over the past few years (prescriptions issued have doubled in the UK since 2019 apparently?) Besins will likely need to cut costs/find extra budget for the setup of the new production facilities they're acquiring to meet the increased demand. Besins will also be needing to expand their supply base for raw materials which, when procuring any agricultural product subject to the forces of nature and different growing conditions in different regions with different suppliers, can be challenging at the best of times let alone with all the supply chain disruption caused by COVID over the last few years and the state of geopolitical flux the world is in right now. Add to that the comparative weakening of the euro over the past few years, and the rise in shipping costs, and whilst I'm sure Besins are excited about their expansion opportunities, nonetheless their procurement and production teams will be having a fairly challenging time of it I'd imagine. Having worked in international import/export & supply chain for agricultural raw materials some 20 years myself, I know only too well the impact on consistency of product quality and market supply these types of challenges bring.
With a cursory look I've spotted some interesting info. I have been googling listed ingredients on the bottles/leaflets on 3 batches of bottles I personally have to hand, being:
1. Oestrogel Conical bottle blue top green square batch 10571 exp 11/2025 purchased February 2023, (Estradiol as hemihydrate & Trolamine). I felt fabulous on this batch, which I've now run out of. I had to fish the bottle out of the rubbish for purposes of investigation.
2. Oestrogel Cylinder bottle white top batch 74736 exp 06/26 purchased 14 December 2023 (Estradiol as hemihydrate & Trolamine). Within 48 hours of starting on this I developed a shopping list of symptoms including infected eyes with swelling, blocked tear ducts and gritty discharge, UTI, constant background headache, exhaustion, deep depression and tearfulness, restless legs, unable to sleep, hot flushes, sore gums, and an unscheduled brief bleed.
3. Oestrodose Conical bottle blue top green square batch 10814 exp 06/2026 purchased 28th December 2023 (Estradiol anhydrous & Trolamine). Note my order to the online pharmacy was for Oestrogel in the old conical packaging with blue top which they assured me they had in stock. Then they went ahead and posted me Oestrodose, which wasn't what I ordered. Haven't tried this one yet but will do, while being aware many other women have reported problems with this product.
Despite knowing nothing about chemistry I googled Estradiol hemihydrate (batches 10571 & 74736 Oestrogel) versus Estradiol anhydrous (batch 10814 Oestrodose). According to the info I read, estradiol is not exactly the same as estradiol hemihydrate, but the hemihydrate is derived from estradiol, and the hemihydrate form is now used interchangeably with estradiol itself. In terms of activity and "bioequivalence" estradiol and its hemihydrate are said to be chemically identical. But it is noted that the hemihydrate has a presence of water molecules which can in some cases result in a slower transdermal absorption rate and/or lesser bioavailability. That said, the hemihydrate is considered to be a highly stable derivative of estradiol.
Anhydrous estradiol , with no water content, can be achieved by further processing of the hemihydrate and requires careful handling, careful choice of ingredients for mixing, and careful storage/distribution processes to be sure there is no unplanned moisture contamination which interferes with its efficacy. However, all things being equal, it's alleged to have a better bioavailability.
When I went to the MRHA website for UK, I found that the leaflets they make available there for these products had been updated by the distributors quite often over the past few months, citing active ingredients variously as Estradiol, Estradiol hemihydrate, and Estradiol anhydrous in separate instances of these leaflets, some of which were only released a couple of weeks apart from each other.
Several older leaflets cited Estradiol (without any reference to hemihydrate or anhydrous varieties) and Trithanolamine rather than the Trolamine which seems to be showing on the current ingredients list. I've seen it alleged that Trithanolamine and Trolamine are both the same thing, but if that's truly the case, why are the names different?
Again as a disclaimer - I have no background in chemistry and I've summarised the the takeaway points as best possible given my limited understanding of complex technical scientific terminology. That said, there seems no doubt that different ingredients are absolutely being used in different batches/production locations.
Perhaps it is legally permitted for manufacturers to substitute ingredients without any disclosure so long as the argument can be made that the chemical activity is "bioequivalent". Could there have been some sort of behind the scenes agreement to this effect with the UK Govt when the "task force" was in place last year to tackle the HRT shortage? I note Besins do undertake that all this product is "quantitively and qualitively identical", which is not in any way an outright statement that the same ingredients and composition are being used consistently across all the Oestrogel/Oestrodose products. This stated bioequivalence could be the basis which we're all being told that all the different packagings, batches, and Oestrodose/Oestrogel, are the exact same product with no difference, so there's no reason why any of us should be fine on one batch and experiencing physical symptoms on another.
However, even according to the variances in the very short ingredients lists on the bottles alone, it is most definitely NOT "the exact same product" across the board in all the batches. And this is before we start taking into account an expanded supplier base with new production partners, different growing region weather, soil, and available fertiliser options, different quality and methods of raw materials processing from suppliers, more challenging shipping conditions, and any bad or faked batches of raw material which, even in the most well established supply chains, do happen sometimes.
Instead of gaslighting all the women raising issues, I do wish Besins would simply be honest about what's happening and work in partnership with their consumers to collate batch feedback, which I'm sure we'd all be happy to provide them if they asked us for it, made it easy for us to report, and undertook to use the information to manage their expansion in a way which also focuses on the quality of the product, rather than just upscaling volume and denying anything has changed, . It's in everyone's interest for Besins to successfully expand their production volumes and scale their supply chain so that all the women who need it can have access to HRT products which really work well for us, as we have done in the past up until now. GPs and consultants making comments like "the women are imagining things because of the new packaging" are not helping. I'd like to see a lot less arrogance and dismissiveness to the public coming from the medical and pharma sector, and more genuine listening to feedback from their users of their products. After all, we have volunteered to be their lab rats by paying for and taking these preparations in the hope there will be menopause mitigating benefits to us. The industry could at least do us the courtesy of paying attention to the outcome of the experiment. Unless of course that's not actually of interest, and they only want our money.
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Topic: Please help. New shaped oestrogel bottle. Is it possible to get a faulty batch? (Read 72766 times)