Oestrogel: new packaging (yet again)?

[Cosmetichamster]

Hi ladies,

Just got this month's prescription for Oestrogel, and I have been issued with a bottle that is new (to me at least). Have a look at the photo: left is what I have known and used since June this year, on the right is the new bottle, also from Besins, same labels, same ingredients, and long use by date (07/25). Obtained from a reputable pharmacy, which has filled all my previous HRT prescriptions.

Has anyone seen this sort of thing? Slightly freaked out here.

Has anyone sent this thread to Bessins? Or is there a pharmaceutical regulatory body that could look into this? Or a journalist? It just seems so crazy that so many women are having this awful experience of all their symptoms flooding back but no one is listening to us.

@Hartieharts All we can do besides investigating this issue is to report the Oestrogel batches that don't seem to work to the Yellow Card Scheme https://yellowcard.mhra.gov.uk/

@WhereAreWeNow Besins has been contacted by dozens if not hundreds of users.

I have contacted the European Medicines Agency and they have acknowledged my question and will write back to me within 2 months.

I I also forwarded this thread to a journalist, but she didn't respond, so I assume she's not interested. She wrote an article about the HRT shortage in November 2019, to which I provided anonymous contributions.

https://www.tortoisemedia.com/2019/11/28/the-great-hrt-scandal/

https://podcasters.spotify.com/pod/show/pharmacyinpractice/episodes/Time-to-highlight-the-unspoken-misery-of-the-HRT-shortages-e9shj4

The Medicines Regulatory Authority looked into this some months ago and the report is on the Government website. The conclusion was that there was nothing untoward found. (I think @Azaleah has made some posts on this.)

There was a similar discussion a few years back when the packaging and name changed to Oestrodose ( a parallel import and how it's named in France) during a shortage (owing then I think to an issue with the manufacturing of part of the packaging.)

If anyone is having huge issues, you could ask to swap to Sandrena or Lenzetto as other options.

@JinglingSpringbells If you're referring to this message, I clearly said this is still under investigation, given the fact that the Government seems unaware that the products are not manufactured at the same factory.

This post...

I was simply directing the poster, who was asking about an investigation, to the fact you had mentioned all of this in your previous posts.

@JinglingSpringbells And I am just saying that what you said 'The conclusion was that there was nothing untoward found' is inaccurate because the government response was based on a false premise i.e. 'the same factory'.

Don't get me wrong, I'm just trying to be thorough with this issue because the thread is too long and most people won't read all the posts.

As an interesting aside... There have been shortages of Oestrogel and Utrogestan in the UK this year, and Besins 'blamed' it on rising prescriptions and menopause awareness. This is not the full picture. I have already mentioned that in April of this year the only HRT drug that has increased in price over a decade was Oestrogel. I was wrong, the price of Utrogestan also increased by 28.65%. This is not a coincidence.

I think it’s the same issue they had before with estoedose vs gel .
if I recall correctly, it’s produced on Belgium but also taken offsite to France for packaging/filling.
maybe some batches for whatever reason get affected. Hence the split in women getting affected vs not .

as fuck the imagining this shit - I went from feeling great to a sweaty mess and emotional in no time . And when my teen was mean I’d start to cry instead of telling her off . I’m sure when I feel off balance and I can’t fake sweating so much I get soaked face and neck ….

@Coffeebutter The issue with Oestrodose V Oestrogel wasn't quite as you have described. (I was using it then - have used it for 15 years.)

During a shortage caused by supplies with the pump mechanism (or other packaging materials) the UK was supplied with the French version which is Oestrodose. This was called a Parallel Import and it had a new sticky label OESTROGEL - placed by the pharmaceutical importer in the UK to override the French on the label.

I have a couple of these now as the pharmacy said it was all they could get, because of demand.

At the time I discussed it at length with my consultant whose opinion was they were identical, as he'd been prescribing gel (and Utrogestan) long before Dr Newson was working in menopause.

The cost I assume is to do with the price of raw materials (yams used in gel and Utrogestan) and worldwide global inflation. I pay for my HRT privately and although there has been a slight increase over the years, I'm not aware of a huge increase. Private prescriptions are 'marked up' by the pharmacy and they can charge what they like - it's usually 1.5 times the price they pay plus, possibly, a dispensing fee- and this can vary between each pharmacy.

@JinglingSpringbells Wild yam (not to be confused with yam) was used in the past as a source of diosgenin, a basic precursor in the chemical production of steroids, but has been progressively replaced by other natural precursors such as phytosterol and cholesterol which are biotransformed (by microorganisms or immobilized enzymes ) into progesterone, estradiol, testosterone and other steroids.

Therefore, the price of yams has nothing to do with the cost, as you assume.

Furthermore, it is not just Oestrogel and Utrogestan that used to contain estradiol produced in this way. Many other HRT products use the same API, beta-estradiol hemihydrate, purchased from the same suppliers. None of them had their price increased on the NHS.

https://www.frontiersin.org/articles/10.3389/fmicb.2018.00958/full

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7570361/

https://bioresourcesbioprocessing.springeropen.com/articles/10.1186/s40643-021-00460-9

The opinion of a GP or Dr. Louise Newson is just that, an opinion. There are many general practitioners, gynaecologists, menopause specialists, and scientists who disagree with Dr. Newson on many aspects of HRT, so why her opinion would be evidence that the products are exactly the same is beyond me.

@JinglingSpringbells If you feel the above articles are too scientific for you, here is one of the few good articles on HRT that explains current production processes. https://www.theguardian.com/business/2022/sep/24/hrt-inside-the-complex-global-supply-chain-behind-a-20bn-market

The opinion of a GP or Dr. Louise Newson is just that, an opinion. There are many general practitioners, gynaecologists, menopause specialists, and scientists who disagree with Dr. Newson on many aspects of HRT, so why her opinion would be evidence that the products are exactly the same is beyond me.

@Azaleah I didn't say that Dr Newson said the products were the same. She doesn't think that, based on her website. The point I was making was that I'd used these types of HRT long before the 'Davina effect' and Dr Newson became a household name and that when the discussion about Oestrodose and Oestrogel was around as a parallel import (years ago.) At the time, there was a discussion about shortages of raw materials and also the containers.

I read the Guardian article at the time it was published.

You said you asked a journalist to take up this whole story. Fancy doing it yourself? Nothing to stop you.

Can anyone hazard a guess if the cylindrical product is too little or too much of the oestrogel? Thanks.

I would definitely say there is none what so ever. I started off at 4 pumps, which done nothing. And the doctor said to try more pumps and I went up to 8 with no effect at all. This was over a few weeks, so I did try and see what difference it made.

My pharmacy is now ONLY giving out cylindrical bottles. The very sympathetic pharmacist checked their other branches and warehouse but they have no stock of the conical bottles. All new stock is cylindrical.

Is this the case with all pharmacies or has anyone had luck getting the conical bottles in August?

Its 1 day since using the conical bottle and the night sweat + insomnia is back! Plus the 'meh' feeling which I'd forgotten about completely!!

Should I move to patches? Anyone tried this? Which patch should I try first?

Has anyone considered switching to Lenzetto spray or another oestrogen source? I'm thinking of asking my gp to switch me.

I wonder if after buying the Drogenbos facility in Belgium from Delpharm, Besins could be having issues with producing two different gels, cross contamination? This is just speculation, so don't worry 😉

Delpharm was responsible for the production of Oestrogel/Oestrodose for Besins and Estreva Gel for Theramex.

Estreva Gel is not marketed in the UK but has been marketed for decades in other countries, including France, initially by Teva and now by Theramex.

The issue is that Delpharm is a huge CDMO (Contract Development and Manufacturing Organization) that has many large pharmaceutical companies as customers, but Besins is only a medium-sized pharmaceutical company.

I wonder if they are having trouble making both gels because Estreva has a different amount of estradiol as well as other ingredients.

The most recent product leaflets for Estreva Gel list Besins Manufacturing Belgium as the manufacturer.

The ingredients from the French PIL:

'Estradiol hémihydraté...... 1,0325 mg

Ethanol à 96 pour cent, eau purifiée, propylène glycol, éther monoéthylique de diéthylène glycol (Transcutol), carbomère (Carbopol 1382), trolamine, édétate disodique.'

Propylene glycol, diethylene glycol monoethyl ether (Transcutol), a different carbomer (Carbopol 1382) and ethylenediaminetetraacetic acid disodium salt dihydrate (EDTA dissodium) are not present in Oestrogel.

@Melstarrynight I switched to Lenzetto because even upping my dose of estrogel didn't work. I love it - it takes a second to apply, doesn't get on your hands and dries in less than a minute. I'm using 1 spray which is the equivalent of 2 pumps of gel (I'd gone up to 3 pumps from the cylindrical packs of gel but don't seem to need it). Apparently you need to be careful about suncream interfering with absorption but on days where I'd be using suncream I just put the lenzetto on my hip or leg so it would be covered by my clothes.

That's great, thank you. (Sorry, don't know how to tag).

Highly unlikely there's cross contamination in a biottech facility as measures put in place.

I agree, but it's not impossible. Lots of new employees, check on LinkedIn.

I have tried Lenzetto spray and it done absolutely nothing for me. I'm back on patches and I hate them, they just seem to make my stomach upset. The weight is piling back on and symptoms are still there but only slightly.
I don't know what else to try 😐

I think the people who are on 4 pumps a day are the ones suffering.

I would actually prefer my periods back 😂 I hate menopause so much 😭

@Hartieharts It will take some time until your 'new' oestrogen levels settle. Be patient 😽

Periods back? Nooooo 🙀🙀🙀😹😹😹

@Azaleah
I've been going throught menopause for 8 years and I've had to swap and change so much in that time due to shortages etc. It just such a pain in the butt.
The thing I dread is my mum is 72 and still going through it 😔