Oestrogel: new packaging (yet again)? - Thread 2

[ConfusedEasily]

Carrying on from a previous thread by Cosmetichamster which can be found here:

https://www.mumsnet.com/talk/menopause/4696464-oestrogel-new-packaging-yet-again

Here's a snapshot of the Drogenbos video showing Oestrodose ready to be sent to the UK (Royaume Uni), manufactured May 2023, Expiry Date May 2026.

My canister has the shiny slightly too small label. It has a batch number and expiry date on the base: 74539 - 03/2026

The label itself has a tiny number on the bottom right corner: 5004742.

The active ingredients says each dose, 1 pump, contains 750 micrograms of estriodol (as hemihydrate), 0.06% - whatever that means.

They might be coming from different manufacturing plants entirely. Now that would worry me.

When testing has taken place on the quality of different generic medications, the variation has been wild! That's why I often ask for a particular brand or the original version of a medication.

@LittleMissSunshiner Oestrogel is manufactured in Drogenbos, Belgium, or Montrouge, France. It's in the patient information leaflet.

Oh, thanks for this info. I didn't actually read the patient info leaflet, doh!

These are my current. The one set aside to send to them was 74502 04/26. I will check which type of label later.

@whiteshutters thank you

I've had an email back from besin and they are wanting me to return a bottle for analysis and had a response email from the yellow card scheme to say they have contacted basin also.
I urge everyone that has had an issue with oestrogel and return of symptoms on same dose to do the same. We need voice in numbers.
I'm back to the gp next week to ask for a swap with patches or sandrena gel....I just can't decide what to ask for. I'm currently on 4 pumps of oestrogel.

@Chrisg79

My GP has switched me out to Evorel 50 as I'm informed that's the equivalent of two pumps Oestrogel and I also did a bit of research that seemed to indicate the same.

Evorel also do 100 and up to 200 I think. Of course, it all depends on the difference how the body absorbs it I suppose.

Personally I think a patch will be so much easier than gel. If it works OK.

I had wanted Estrodot but forget about that. It's in some crazy production shortage fluctuating situation all the time and the companies that order in for pharmacies can't get a hold of it.

What I understand from people I know working in pharma is that many things are made in different companies, under contract.
Some will make the labels
Some will make the containers
Some might make the plastic inner bag
Another supplier will provide the purified water....and so on....

Raw ingredients are tested as they come into the lab.
They are double tested as part of the manufacturing process.
Batches of drugs are checked by several teams and managers before being released.
It's a highly controlled process going through layers of quality control before being finally signed off .

all sorts of factors could make a difference or cause an unaccounted for chemical reaction that alters the potency of the gel, including the fabric of the canister itself.

No.

This doesn't happen.

Interesting response from Besins:

"We are aware of similar complaints raised to us directly due to different bottles. As such, we are thoroughly investigating these complaints and have consulted the manufacturing site, which confirmed the investigation and testing of returned containers from complainants are still ongoing"

So at least they are investigating at the manufacturing site and not just saying the standard 'it's all the same product' gaslighting response now.

Sorry not sure why the photo of their letter isn't showing properly! Here's the text:

Dear...

We are sorry to hear that you have experienced a recurrence of symptoms while using the cylindrical Oestrogel (estradiol) Pump-Pack 750 micrograms/actuation gel.
We have forwarded your details to our Drug Safety and Product Quality teams. They will contact you to gather more information concerning the report you have made regarding the return of symptoms while using the cylindrical bottle.
We are aware of similar complaints raised to us directly due to different bottles. As such, we are thoroughly investigating these complaints and have consulted the manufacturing site, which confirmed the investigation and testing of returned containers from complainants are still ongoing.
In the meantime, we would advise that you speak to your prescribing clinician regarding any concerns that you have about the treatment as they are best placed to provide you with advice relating to your personal medical condition and history. Should your doctor require further information regarding your enquiry, they can contact us directly.
We hope you find this information useful.
Yours sincerely,

On behalf of BHUK

@MumOfOneAwesomeHuman that’s exactly what I got from Besins, and today have an email asking me to return my gel to them for testing.

Yes I just got this too.
Having slept blissfully for two years in HRT I’m back to waking at 2.30am, dry eyes, dry mouth, palpitations, anxiety 😦
Thought I was going mad until I found other women having the same experience on here and a peri account. Luckily I’ve found a bottle of the OG in my cupboard so back on that since yesterday and symptoms are subsiding again but will need to sort an alternative soon. The problem for me is our GP is a) rubbish, b) impossible to get an appointment with! I was prescribed hrt privately so will have to go back to private dr, pay for private prescription then get gp to agree to the change. It’s so much hassle and I have a hugely full on job and a teenager. I just don’t have time for this or time to be an anxious peri-menopausal mess!

Sorry to hear your GP is so crap. Most of them are these days IME. Mine is nice but hard to get a hold of.

Have you tried using the NHS App and online communication with your GP instead of actually trying to see or speak with them, this is what I've been suggested.

Otherwise I'm assured by many people that these online GP services are excellent and cost approx £10 - £15 a month. I know why should we have to pay for it etc but everyone I know who's done it says they get excellent service.

Thanks LittleMissSunshiner I'l try that. 🙂

I've been to the pharmacy this morning and taken my bottle back for them to send back to besins for testing. I hope I get some feedback.
The pharmacist listened to my concerns but said she hasn't had any other bottles returned but she is only part time.
They are only able to source the new style bottles now, but there seems to be 2 types of stickers.
Anyway back to the gp next week to discuss alternative estrogen.

@JinglingSpringbells I totally agree re: no chance of chemical reaction, etc. I think personally upon reflection that the problems I had sporadically over the years (been using it on and off since 2015) were related to the pump delivery - either faulty pump or 'operator error' on my part. I haven't used this product recently so have no idea how effective it would be for me now but it does make me nervous trying it again, which is why I'm thinking Sandrena may be a better option for me. I don't do well with fluctuations at all.

Excuse me if you've covered this in this topic elsewhere, but have you mostly found the Estrogel OK yourself as a long term user? I'm trying to decide what to choose at my appointment next week as I loathe the patches for their unsightliness and skin irration especially as Estradot are now virtually unobtainable.

The additional problem this has brought is that I used up my supplies more quickly. Add that to the incompetent record keeping at my GP and you end up having to speak to the GP to explain all of this to her who then says she doesn't like women of my age on this level ( 4 pumps). I paused for a few seconds then reminded her that I was not coming off it and had written a letter previously to them to state this. The prescription was issued.

@Azaleah do you think the new bottles are oestrodose not estradiol then?

@Chrisg79 Both Oestrodose and Oestrogel are estradiol.

IMHO the difference between all Besins' estradiol gels (marketed in different countries as Oestrogel, Oestrodose, Gynokadin and Estrogel) is the manufacturing site.

Different manufacturing sites in different countries mean different raw materials' suppliers and different teams.

Besins should dedicate one manufacturing facility for estradiol gel and the other for testosterone gel, but I suspect the logistics costs would increase.

Since 2012 the manufacturing site in Belgium has been owned by Delpharm, and the gel has been consistent regarding symptom management.

In 2018-2019, Besins had to start production at their own laboratories in France (Montrouge), where they already had been producing Oestrodose for the French market and parallel imports in the UK, due to the higher demand in the UK and elsewhere.

In 2022, the 10 year contract with Delpharm has ended and Besins has purchased the Drogenbos manufacturing site back (Besins was the original owner before 2012).

I suspect Delpharm hasn't given Besins all the details about the gel manufacturing, which they certainly have perfected in a decade, now that they are no longer partners.

Until Besins gets on its feet again, I'm afraid the gel will take some time to acquire the same quality as before, but it will happen eventually.

@Azaleah wow thank you!! So many factors of variability!!

I've picked up my Evorel 50 patches today and will start them tomorrow. Fingers crossed this is a smooth transition and will be less messy than having to mess around with alcohol gel.

Estrodot by the way, forget about it IMO. It's listed on plenty of online sites but they actually don't have it, some pharmacies say they can get it then days later say they can't and Boots have told me they no longer attempt to purchase it as their buying department have taken it off the list.

Third different batch of oestrogel opened last night, this one still the new cylinder but slightly different box and the matt not shiny label. I slept! Still looks to be piping out less than the conical one so I did put a bit more on, but fingers crossed this continues.
Good luck @LittleMissSunshiner hope patches work for you, I can be funny with adhesive allergies so they would be a last resort for me sadly.

I am keeping an open mind on this in terms of personal use as I have yet to start the new bottle.

However, there are some things here about the pharmaceutical control process which are assumptions.

A commercial sale/buy-out by a company doesn't mean all the manufacturing equipment, raw materials and scientists change. It's a commercial transaction unless the factory is demolished and rebuilt.

The entire manufacturing process goes through regular scientific audits of raw materials, the machinery used, the batches of drugs, and a whole team of quality specialists and pharma regulation. Within pharma there are scientists doing nothing else, all day, except quality control for every batch of medicines. To be in breach of quality control has serious consequences not just for the company but also for the quality person who is ultimately responsible (in the EU and UK it can, in theory, result in imprisonment.)

I'm not saying there isn't an issue, only that any company needs to investigate to protect their reputation once complaints are made.