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.

Hi

despite the same ingredients, some is manufactured in France for the french market and had/has a green square on and a batch number starting with ‘1’ (the parallel import is estrodose and has a green square on the bottle) the bottles with an orange square and batch number starting with ‘7’ are manufactured in Belgium for the British market. Besins have denied there is any issues because the same ingredients are used but many women have reported issues and it’s mainly with the bottles with the green square and has nothing to do with your needs changing, i had issues with the green bottles as have my friends. The batch number is on the outside of the box and I won’t have any gel that has a batch number beginning with ‘1’. Also if the insert says manufactured in Belgium the square will be orange and if it says France or Belgium it seems the square is green. The gel in the bottle with the green square is a lot runnier and you have to rub it in really quickly. The only conclusion so far is the way it’s stored and transported differently.

@Helswatts That doesn't quite tie in with mine because going on your description, mine is the French version. I'd need to look again but I think the use-by date is 2024 (it's always 2 years after production.)

I have the 'old' flagon style bottles. They are labelled as Oestrogel. There is a green square. Yes, the batch number starts with 1. (But it doesn't always, as I've used it for over 12 years.)

The label says they are manufactured in France but the outside carton also gives the Belgium address as that is Besin's.

I have not noticed any difference in the consistency and no difference in efficacy.

It would be very surprising if there were issues with transportation affecting it, as this is very strictly controlled with pharmaceuticals, not just hrt.

Can I ask what consistency the gel is supposed to be? I've just started oestrodose (I am in France) and the bottle looks exactly the same as the one on the left in OP's photo in terms of shape and little green square. I was told by GP here it was exactly the same product as the oestrogel I'd been prescribed by the really expensive private UK menopause clinic, but I googled after reading what @Helswatts reported - I can see that since 2020 there was stuff on social media about this and complaints made to MHRA who said..

Both Oestrogel and Oestrodose are made by the same manufacturer in an identical manner and in the same factory, so it is expected that they work equally well.... we and our colleagues in the Defective Medicines department within the MHRA have been investigating whether any factors in the manufacturing or supply chain could account for these reports. This has included confirming with the manufacturer that no changes in manufacturing process have occurred and requesting additional information from reporters, where appropriate, to identify whether specific batches may have been affected. Investigations to date have not suggested any underlying issues....

I'm loath to fork out for private UK prescriptions but I can see that a number of women firmly believe oestrodose is an inferior product..

@Mayflier My understanding is that in France, and Europe, it's usually labelled as Estrodose. In the UK it's been Oestrogel.

There is a longish history of supply issues and in the UK some pharmacies were only able to get hold of Estrodose as a parallel import.

I have had both, all on a private prescription. The cost was the same. Having a private prescription made no difference - down to what the pharmacy could supply. All I have noticed is that some larger pharmacies seem to have access to Oestrogel more easily as they maybe use different wholesalers.

I've had both types at the same time ( eg Oestrogel, then the next batch I collected could be Estrodose). I've noticed no difference at all, even squirting both onto my hand I can't tell any difference.

I squirt it into my palm and it doesn't run or slide. It's jelly-like and even if I tuned my hand upside down, it wouldn't fall off.

I did ask my meno consultant (private) and they believe there is no difference and it's subjective.

OP and others if you are concerned at a genuine change with your medication report it here yellow card or report to your pharmacist who will do this for you.

Thank you @JinglingSpringbells Ok so it sounds like it's the same stuff as the gel doesn't slide off my hand and doesn't seem runny or needing to be rubbed in with any haste. It makes a huge price difference for me as in the UK I need private consultation (£165!) as I'm not registered with a UK NHS GP anymore. They also said I would need to make that appointment every 3 months as they are not allowed to prescribe more than 3 months at a time? It's a very hefty wedge of cash v just going to the GP in France! Thanks again.

I hope you feel a bit reassured.

It's true that at the moment gel is listed as a shortage medicine, so 3 months is the limit.

However, it's usual for a private specialist to charge that amount for writing a prescription (you're being ripped off.) Neither do you need a review every 3 months. I have a review roughly twice a year (legally they have to do an annual review). So, you ought to be able to have your prescriptions without a review each time. Some private consultants will charge for the admin behind sending the prescription (if they aren't renewing it when you have a consultation) and it's around £30-ish.

usual= unusual!

Yes Estrodose is the parallel import and has a green square on it, but estrogel has either a green or orange square on it, the bottles with the green square are produced where the parallel import is and is runnier and myself and friends have had issues with this. There is information on the green square orange square issue on IG periandme.

They are the same product/same ingredients but many women have found the bottles with the green square whether Oestrodose or Oestrogel are runnier and their symptoms have returned, although Besins deny there is an issue, the yellow cards would say otherwise. I have read that only explanation is that it is stored and transported differently as the green square bottles are manufactured in France, and the orange square in manufactured in Belgium for the British market. If you google Liz Earle wellbeing oestrodose vs oestrogel there is a good explanation on there.

It's all anecdotal. There is no science behind all the claims that it is different. I know I'm not going to be popular saying this, but it's a rumour with no foundation. It's gone on for a few years, since gel started being more popular.

I have had both types at the same time (an overlap between an old and new bottle.) Spurred on by these threads I've looked very carefully at the consistency (on the same day) and have seen no difference whatsoever in the thickness or efficacy. The green square bottles are manufactured in Belgium- that's what's on the cardboard box of mine.

It makes no sense to discuss transportation issues. The inner plastic pouch (which is airtight) is contained in the rigid plastic carton, (I've taken it all apart when I was running low, to get every drop out!) then that is in a cardboard carton. The gel is stable unless the temperature gets very high indeed.

If I remember correctly, the article on the Liz Earle site is written by a beauty/health journalist and isn't a scientific article. She assumes it's to do with transportation, but that is completely unfounded. She's basically picked up on rumours online (her sources are online forums) and uses words like 'possibly'.

I'm sorry but I believe a lot of women are being brainwashed into thinking there is an issue when there is not. If symptoms return, see your GP.

I pay for my HRT privately, and if one was an inferior product, I'd be told. I've been advised that this is simply a rumour.

Oestrodose, manufactured in France, does not slip when you turn your palm upside down. It is not runny at all. So if UK women are given Oestrodose it should not be runny, no matter where it was made.

I’ve noticed a return of my symptoms since starting on the new bottle too and have just found this thread after searching for why my symptoms are particularly bad now. I was completely fine until I changed to this bottle..

I understand the strict controls with medication, after being a nurse for a long time, but am convinced my symptoms are due to the change in packaging. There doesn’t seem to be as much gel per pump as the old style bottles. I’m going to see if I can get an older style bottle from somewhere and see if that makes a difference and will report on the yellow card scheme.I’ve slightly increased my dosage as well to see if that helps.

The way this all started- maybe about 8 years ago?- or less, was that there was a shortage of gel. Not as bad as now, but still some issues.

In the UK, wholesalers started acquiring Estrodose which was the name of the gel in France and Europe.

It was called a parallel import because although the contents were identical, the shape of the bottle was different and UK pharmacies were allowed to cover the Estrodose label with one saying Oestrogel.

This led to some women linking a change in symptoms to the new bottle and the rumour about 'transportation'.

And so it began....

This story has run for years. Someone here posted a response by the medicines regulating authority who looked into this, Besins themselves have responded many times, and there is no evidence of any difference just because the bottle has changed.

I am sure that some women will carry on believing it's changed, but there is no evidence at all and I've noticed no difference even though the packaging has changed 4 or 5 times in the years I've used it.

To be really blunt, it began as an unfounded rumour that has run and run, and needs to stop because it's can stop women finding other solutions to their symptoms (lifestyle changes along with HRT, or increasing the dose, or changing to patches.)

I do understand all that and quite honestly the packaging doesn’t bother me one bit but I know that I was absolutely fine until a few days after I started this new bottle and my symptoms started seeping back.
It does seem as though there isn’t as much gel per pump so I’ve increased slightly to see if that helps..

Thank you for taking the time to explain it all though, your input is appreciated and it does help x

Ive noticed same. My symptoms have returned using a gel with different packaging.
Im thinking, if the packaging is the same as some gels from years ago whats to say they are passed their use by date and labels have been changed (due to shortages) years ago hrt wasnt in such high demand, and lets face it something like this has been known to happen.
The gel on the right is my regular
The left my symptoms returned

@SamR36 The bottle you have shown (conical bottle) is the current bottle. I have that shape. Mine has a use by date of end 2024.

Use by date is on the cardboard outer carton.

Besins Healthcare (UK) HRT products

Information for the public from Besins Healthcare (UK) Ltd regarding Oestrogel® (estradiol (0.06% w/w)) Pump-Pack 750 micrograms/actuation Gel supply status:

We are continuing to deliver significant volumes of Oestrogel into wholesalers to meet the continued rising demand we are experiencing. To boost supplies of this product further, from September 2022 Besins Healthcare will be introducing an additional bottle for Oestrogel into the UK. The additional bottle is a cylindrical shaped bottle with a white lid and contains the same medicine as the current, conical shaped bottle with a blue lid. The additional bottles will greatly increase availability of Oestrogel for patients prescribed this product in the UK

It would be madness for a pharmaceutical company to tamper with use by dates. It doesn't happen.

And here

www.besinshealthcare.co.uk/wp-content/uploads/2023/01/BHUK_2022_347a-Product-Supply-Update-No.4-Jan-23-v1.pdf

Pharma companies outsource their packaging from many suppliers.
In this case, they have been able to procure some older style packaging to help deal with demand.
The gel itself is not old stock.

Your photo shows a use by date of 11/24.

I've just noticed the same change - not due to new bottle shape. In fact I'd just finished and been fine on a bottle of that shape.

I started a new bottle (old shape) on Tuesday (poss Monday). By Wednesday night I was hot in bed (a symptom for me) and by Thursday evening I was very emotional, feeling miserable and crying for no reason. This went on for hours.

It was this symptom - endless crying for no reason - that caused to me try HRT in the first place. Nothing had changed apart from starting a new bottle - and I'm not at a flex point in my cycle.

I found another bottle from a different batch, used that yesterday and this morning I feel back to my old self and was not hot in bed last night. I had a lovely nights sleep.

I've been using the gel for over a year and remember comments about some batches not working a year or two ago. Never had that issue before but luckily I remembered the chat, and found some threads on a different website.

The batch I've had a problem with is batch no. 10502 and exp. 09/2025 in case that is helpful.

I am trained scientifically and not one to be swayed into believing something chat on an anonymous forum. BUT my lived experience is that this batch does not for for me. I don't know why, but that is the reality. It may not affect every woman the same. Others may have been unlucky/lucky with batches. 🤷🏼‍♀️I don't think it is helpful to blame (female) hysteria. Hasn't that trope been done to death?

@JinglingXmasbells it has been known for use by dates to be tampered with. Madness or not. Quite easy to put another label on just about anything.
And pharmaceutical company's will do what it takes to make money.
Like ive said before you can't be so matter of fact with everything.
I personally don't believe all i read.
I know for certain that my symptoms have come back since using this gel, same shape bottle or not. It can't be coincidence.

it has been known for use by dates to be tampered with. Madness or not. Quite easy to put another label on just about anything. And pharmaceutical company's will do what it takes to make money.

Okay. So link to those examples? Let's see the drugs that were tampered with.
I have never seen any evidence of dates being tampered with but am very happy to see the evidence if you can show it.

Pharma makes next to nothing from HRT.
A month of gel costs £9 at RRP (I pay for mine, not NHS.)
A month of the newest cancer drugs cost £15K.

@JinglingSpringbells ive not got the time to look for evidence, but believe this happens, quite the same as you not having the evidence to prove that it does not.
We just have to agree to disagree on this matter.
I believe in everyone having their own opinions and each being valid.
When i have time later i shall search for links.

Also want to add. You seem awfully agitated by others opinions..

There seems to be a lot of anger here which seems odd to me.

But my takeaway from this is that I am not alone in thinking something is wrong- whether in a particular batch, or otherwise.

I really hope everyone affected will report their experience to their GP, their pharmacist, to Besins, & on the Yellow Card scheme and would reiterate - we have a Yellow Card scheme in order to identify patterns. Patterns cannot be identified without reports being made.

Please report problems with medications, whether this product or anything else.

I honestly don't mean to come across angry.
Just whenever i post anything my reasons & opinions are invalidated.
Im stepping away from this forum & just going to flit in & out to read posts for advice.
@Cherryann i shall act on your advice and do so. As im 100%certain the gel ive been using this past few weeks have been ineffective

I don't see what else anyone can do to convince women that the gel is the same.

Some women who feel there is some change have also changed types of HRT many times, are in early peri, (so their symptoms are always changing anyway) and having a problem finding something that works.

The MHRA said in 2020

Both Oestrogel and Oestrodose are made by the same manufacturer in an identical manner and in the same factory, so it is expected that they work equally well.... we and our colleagues in the Defective Medicines department within the MHRA have been investigating whether any factors in the manufacturing or supply chain could account for these reports. This has included confirming with the manufacturer that no changes in manufacturing process have occurred and requesting additional information from reporters, where appropriate, to identify whether specific batches may have been affected. Investigations to date have not suggested any underlying issues

Besins have also made their own statements on it.

If the MHRA say it's fine, surely that is enough?

When this issue first came out on the web, years ago, there was all sorts of misinformation flying around. I won't list it as it would take all day!

The plastic pouch inside the carton is filled with the same gel, regardless of the outer plastic carton or the cardboard box.

Besins have no need to re-label old stock with new dates as there is no old stock. It's been in short supply for ages. They have increased production and part of being able to supply the UK has meant they have used a different shape bottle, presumably because the manufacturer of them was able to up-scale production.

I won't be adding any more to this thread but if you are sure it's the gel, report it and see your GP. And I hope everyone gets something that works for them!