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.

The issue lies when in England we get bottles with green squares instead of orange squares or vice versa and the cylinder bottles and also the PI Oestrodose.

Exactly. Besins distributes their products worldwide, but the UK market is quite unique because of the NHS.

In France, I suppose all you can get is Oestrodose manufactured by a single facility. The market is probably not as big as in the UK.

Menopause awareness is a big factor in the UK, not to mention transgender people who also use huge doses of the gel.

Evidence of this is the amount of parallel imports in the UK market. If you access the MHRA products website and search for Oestrogel there are many patient information leaflets of parallel imports (PLPI), which had been on the market in the past and some of them still are.

I have written an article about this but haven't published it because I lost interest when users and menopause 'experts' were making a big fuss about it but as soon as Besins reassured the government that the shortages would stop, they seemed relieved and forgot all about the gel inconsistencies. To be fair I haven't checked this on social media recently. Fed up with Instagram, FB and Twitter!

I have posted a link on this thread but I'm not sure if it still works so if anyone is interested I can upload it on a hosting site and provide a link.

It's a huge business! Besins exports the gel to a hundred countries. The changes in packaging have been implemented in some but not all countries, because Besins has requested it to some health agencies but soon after they have withdrawn the request.

My theory is that they tried to produce the gel themselves after their contract with Delpharm expired or they wanted to relocate the production to France.

Something clearly went wrong and they decided to buy Delpharm's facility in Drogenbos, Belgium, which Besins had sold to Delpharm back in 2012.

Their production team and ingredients suppliers are probably not the same, which would explain the gel inconsistencies, along with the two different packaging suppliers.

So...

The current Oestrogel inside the cylindrical bottle (white lid) is being manufactured by Besins in Drogenbos, Belgium. They have batch numbers starting with 7.

The old cylindrical bottle (white lid) which used to be the Oestrogel packaging had gel produced by Delpharm until the change of packaging to the conical bottle (which has always been the Oestrodose packaging).

Delpharm is a CDMO (Contract Development and Manufacturing Organisation) which had been responsible for the gel production from 2012 when it acquired the Drogenbos facility from Besins, to June 2022, when Besins acquired the facility back from Delpharm.

The Oestrogel inside the conical bottle (turquoise lid) with an orange square 🟧 has been manufactured by Delpharm in Belgium until June 2022. Batch numbers starting with 7.

The Oestrogel and Oestrodose inside the conical bottle (turquoise lid) with a green square 🟩 has been produced by Besins in Montrouge, France. Batch numbers starting with 1.

The older Oestrodose without a square was probably produced by Delpharm, but it is possible that it was produced by Besins at some point in Montrouge, France.

Besins tried to produce both Oestrogel and Oestrodose in France (green square 🟩) but apparently they couldn't cope with the demand so they have decided to buy back the Drogenbos facility, instead of paying Delpharm to manufacture them as a CDMO.

The brand names (Oestrogel and Oestrodose) are different but the gel is supposed to be the same. The difference is the manufacturer!

Gel in the conical bottle (turquoise lid):

🟩 = Besins (Batch numbers starting with 1)
🟧 = Delpharm (Batch numbers starting with 7)

Gel in the cylindrical bottle (white lid):

Batch numbers starting with 7 until June 2022 = Delpharm
Batch numbers starting with 7 after June 2022 = Besins

Oh an there was an Oestrogel cylindrical bottle with a turquoise lid at some point 😂😂 Don't ask me why!

Thanks for the information is it the green square, 10 code and turquoise lid that’s causing the return of symptoms? I’ve had some other health issues hopefully now resolved but had a big increase in hot flushes, moods & joint pain and wasn’t sure what was causing it. I’ve got a new bottle with orange square that I can try next maybe I should..?

Thanks for all that info, @Azaleah

I've had a couple of turquoise lid conical bottles - batch no 1xxxxx orange square - which I haven't got on with.

Raised a yellow card for these. Might seen like a waste of time but I'm sure that if there is a significant increase in reporting issues then the NHS will require that Besins do a greater level of research & investigation!

I've just started a white cylindrical bottle, batch no 7xxxx, and seem to be fine on it. Was a bit surprised by this, but having read your post it all makes sense.

I've only ever had Besins produced gel (apart from those 2 mentioned above) and 4 squirts of that does me fine. But I need more if I use the Delpharm version.

I've got the square colors wrong - but that batch numbers and shapes are correct. <bangs head>

@agnesmartin Are you sure you had an orange square with batch number starting with 1?

@agnesmartin It is confusing! I hope it keeps working for you 🤞🏻

It depends on which version you were using before changing to a different version.

Some women don't feel any difference but some are probably more sensitive to small changes and feel worse on a different version of the gel, sometimes requiring to tweak the dose.

New Besins factory in Spain...

https://investinaragon.com/worlds-leading-company-in-hormonal-therapies-besins-healthcare-installs-its-newest-factory-in-aragon/

More troubles ahead?

Yes, when I started reading this thread I was a bit disconcerted that I was getting an inferior product in France v what had been provided in the UK, but actually, irrespective of whether that's the case, the major advantage seems to be consistency of supply. If something changes for me, it's likely to be my body rather than the product. As I said, the only discussions I could find from menopausal women in France were from 2018 when apparently there was a shortage (also for Estreva, don't know what that is in the UK market). I do hugely feel for people constantly having different colours, codes and packaging as it must feel like a lottery and that's the last thing you need when your hormones are fluctuating - it's all confusing enough already without manufacturers messing things about!

@Azaleah Here are the bottles and inserts. I'm ok and very happy with the bottles in the left if the pictures and awful on the other.

Thanks @Muttley47 "The pouches are clearly different. Can you post a photo of the pumps?

Hi @Azaleah here are the pumps. The white topped pump looks inferior/more economical in quality to the green. The green has a metal ball and spring, and a tubed/long part that goes into the foil pouch/bag with the gel. Whereas the white topped bottle is directly slipped onto the plastic pouch.
When I have prized bottles open to collect the remaining gel from the pouches, (there's at least a dose) the green bottle with its foil pouch has to be cut/pulled away, and the white simply comes off easily.

@Muttley47 Thank you so much for posting these photos. It seems almost impossible to get the 'exact' same amount of gel from these absolutely different pumps and pouches!

It's all very odd and my friend now has a bottle like the one of the left, but with a green square, she says she feels awful on it and the cylindrical bottle, yet fine with the orange square on the left.
I find the gel consistency different in all these gels. So the white top here, is thicker that the one I like.
I don't what else to say, it seems odd so many have issues and why are there so many bottle types...

I've been up since 3 am this morning. Last night it was 4.45 am.

I added an extra pump with the cylindrical bottles and im fine, noticed symptoms return so upped it. It feels less amount each pump and even worse as your getting to the end. The Oestrodose i had awful time with but ok on this. It seems anything starting batch number 7is ok with me. Although i did yellow card it at 1st whilst lieing awake at stupid o'clock, then increased dose as had no other option.

I probably need to do this as my symptoms returned with the cylindrical bottles, however I'm already on 4 pumps, which is all that's licenced for prescription 😢 I'm not sure taking 5 is allowed?

I've always had the conical bottles with turquoise lids, (current ones have batch nos 7#### and an orange square) but my last prescription is of cylindrical with white lids, batch numbers 7#####. I took one of the new bottles on holiday, about 2 weeks ago and I think it was OK, but have finished that one and gone back onto a conical/turquoise lid one.

Since getting back and have had rubbish sleep, one night sweat incident plus feeling itchy, which I've never had before. Not sure which one was causing the syptoms.
I've got an appointment with my GP next week so will mention it.

@Skinnybluebody I can't give you medical advice, 4 pumps seem a lot already. Can you try contacting your surgery? Maybe change to patches until Besins fix these issues?

@MagpiePi That's expected when you keep changing products that are not exactly the same.

It's not that one or the other product is causing the symptoms, it's the changing of the estradiol amount that's being absorbed that upsets the balance.

Only 10% of the actual amount of estradiol in the gel is supposed to be absorbed by the vascular system in the skin and daily application of 2.5 g or 5 g over a surface area of 400-750 cm2 results in a gradual increase in oestrogen blood levels to steady state after approximately 3-5 days.

That means every time you switch products and the estradiol amount is less than expected the steady state might take longer to be achieved and the symptoms return.

It was a rhetorical question. I wasn't asking for you to give me medical advice.
4 pumps is the maximum prescribable by GP's so not a lot. Some women, especially younger women, do often need more than this.
I maintain open lines of communication with my GP regularly so am in the process of trying alternatives.

@Skinnybluebody Sorry if I misinterpreted your post. You said you were not sure taking 5 is allowed, but now you seem quite sure?

I was referring to the manufacturer's instructions based on clinical trials.

Everything else is trial and error and the risks are the patient's choice based on an informed decision, assuming their GPs are knowledgeable about it.