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.

@Azaleah , what you written concurs with everything I have experienced. Unfortunately, I threw my first straight-sided empty bottle away before I realised it was the cause of my problems. I have two left but don’t really want to use them as I can’t face feeling worse again! I’ll give it a go when I can 🥴

My goodness! What a minefield😲. Thank you to those of you who responded to my post ... certainly sounds like there are real issues with the cylindrical shaped bottle in particular. That definitely ties in with my experience. I had assumed the effective dose of estradiol being delivered by the new cylindrical design must be less than the conical pump (it looks less to the naked eye though I saw another person here saying they'd weighed it and is the same🤔). but I'm nervous about increasing my dose too much as already on 3 pumps and the thought of this being the wrong decision and feeling even worse is pretty terrifying. If I knew for sure that the cylindrical pump is providing less estradiol, I'd confidently increase but I guess we can't be 100% sure...?

Thanks for your feedback!

So... batch numbers starting with 7, whether they are cylindrical or conical bottles, are being manufactured by a different team, Besins instead of Delpharm.

They are not exactly the same as the batch numbers starting with 7 produced before June 2022.

Some of these batches produced by Delpharm are still being marketed as their expiration date will be until June 2025.

I’m going to check what I’m currently using as I’ve actually started getting hot again over the past few days - even on the conical bottles :-/ I’m hoping it’s me, rather than them, this time…!

@JoCushionIf the conical bottle you're currently using is either batch number 10### (green square) or the more recent 7#### (orange square) with an expire date after June 2025, the problem is not you...

I agree it's odd the amount delivered by one pump from different bottles weighs the same despite not 'looking' the same.

I can think of two variables that could account for this apparent paradox: different consistency and a problem with the 'airless' mechanism.

Consistency is basically given by the amount and type of carbomer.

In the past there was a change of type, carbomer 974P to 980 NF (also called by their brand name Carbopol).

The first one was prohibited in Europe because it is produced with benzene, but it's still the one used by the Estrogel manufactered in the US, and only recently changed in the Oestrodose patient information leaflets in France.

We can't know which and how much carbomer is being used now because all the latest patient information leaflets just say 'carbomer'.

If the airless mechanism is faulty, i.e. when you press the pump air is entering the pouch, you might get air back when you press the pump again, so the amount of gel will weigh the same but it has air trapped amongst the gel, and you will get less amount of estradiol.

I’ve just found a few bottle with an online chemist that’s hound be correct batch and correct bottles , orange square batch no 7 however, just started bottle yesterday and feeling terrible today , no energy , moods really bad , can motivate , can’t stand smells it’s awful. Sat here crying as I write this. Had just got myself back up. Gel consistency not feeling quite right. Now what’s going on? I’m on 5 pumps a day , yes unlicensed due to severe symptoms and had to get private help at great cost that I cannot sustain. Anyone found this? Xx

Poor thing 🤗 Can you post the expiry date? The gel in the bottles with the orange square 🟧 batch numbers starting with 7 and expiry dates after June 2025 are the ones produced by Besins and likely less effective than the ones with expiry dates before June 2025.

Hi the new bottle is exp 12/25 whilst the bottle I’ve just finished was 01/26 and they were ok. I thought I had this sorted and now I’m so confused?

It depends on which type of bottle we were feeling ok.

Can you post a photo of both? It's important to post a photo of the back of the bottle where batch number and coloured squares can be seen.

If you were using the conical bottle with an orange square 🟧 exp date 01/26 it would have been produced in 01/23, so probably by Besins in Drogenbos, Belgium.

But maybe they are using old bottles so it would be difficult to know for sure.

Old used bottle left new opened bottle right side.

@Birdwithaview73 Thank you 😊

It seems they have come from the same manufacturing facility.

What exactly have you noticed regarding the consistency of the gel?

Are you peri or postmenopause?

Hi I’m menopause at the mo not peri. It’s just felt more watery than the last gel. I’ve been so down today but nominally I am fine and I’ve had no energy. They surely can’t mess us women around with this dodgy batches. Going to try to talk to gp for alternative as I can’t manage going up and down when it take long to get back up again.

I agree. Maybe you will be more stable on patches. Fingers crossed you will be able to talk to your GP.

@Azaleah Now I'm baffled. I had a bottle shaped, orange squares bottle of Oestrogel that I felt amazing on. I have requested from a pharmacy the same again. I was over the moon to receive 3 bottles that looked the same, but I've noticed I'm not feeling good, getting flushes and my mood isn't as it was. The gel is less in a pump, thicker and dries really fast. My friend pointed out that the Belgium address is different to the 'good' bottle. What are they doing!?
This is causing quite a few women quality of life issues.

Well, I'm not, that's exactly what I would expect if the batches are being produced by Besins' teams irrespective of the manufacturing facility. They don't seem to be able to produce consistent batches of the gel.

I know the pharmaceutical industry has to follow strict guidelines blahblah but in the end it's people who are behind the production line. After the pandemic the whole thing has been changed, even the EU medicine regulatory agency has been changing the rules to allow the pharmaceutical companies to avoid shortages and price increases. The ultimate price is loss of quality Im afraid.

I have sent a message to EMA about this case. Let's hope they reply soon.

I'm so relieved to have found this thread. I have been on the conical bottles for a while and have felt great.
Started the cylinder bottle 10 days ago and feel like I've been plunged back into the darkest, depths of menopausal despair - anxious, irritable, low mood, tender breasts, murderous feelings towards perfectly innocent husband - so bloody miserable. I couldn't work out what was going on.
Have tried using extra pump but still feeling a bit unhinged...
Post

@nummy2 Sorry to hear that, but your symptoms sound more like due to excessive oestrogen. Maybe decreasing one pump would help. This gel mess goes both ways, it could have more estradiol per pump than the last one you had.

That's interesting, thanks - I've only been on 2 pumps a day, so tried doing a third at night. Been googling symptoms of low and high oestrogen and confusingly, keep finding same symptoms eg breast tenderness, anxiety for both?!

Yes, it's a bit confusing, but the explanation is that oestrogen works in an inverted U shaped curve, meaning you have similar symptoms when the levels are too low or too high, the sweet spot being at the medium level (the curve inflection point,).

@nummy2 And applying the gel in the morning and at night might not be a good thing. I would apply it in the morning irrespective of the number of pumps.

@nummy2 It's fine to split the dose and in fact the BMS (British Menopause Society) has this on their website somewhere, as a suggestion for women using more than 1 or 2 pumps.

I use 2 pumps but split it am /pm and have done for around 15 years. It suits me better that way.

Absolutely, that's why I said 'I would...'.

My decision is based on the clinical trials performed by the manufacturer of the medication (Oestrogel patient information leaflet says in the morning OR evening) and on studies regarding the cirdadian and ultradian rhythms of oestrogen in women stating that the peak of oestrogen secretion in premenopausal women occurs in the morning.

HRT is supposed to 'replace' the natural hormones, so timing is important.

Can you post a link to the studies referred by the BMS? I couldn't find anything when I searched for 'split doses' and similar search terms.

Glad to hear it works for you, though!

https://thebms.org.uk/wp-content/uploads/2019/11/HRT-alternatives-04.11.2019.pdf

In the above, on each page, there is a reference to using Oestrogel as 2pumps am, plus 1 pump pm, where women are trying to create the equivalent of patches etc (if there was a shortage.)

There are also references to splitting the dose in other BMS papers (I just don't have the time to pour over these, sorry) as they say it can give a more constant dose especially in women who use more than 2 pumps.

The additional reason for that is it is sometimes physically impossible to apply more than two pumps thinly (one to each inner thigh and/ or upper arm) and for it to dry, as the area covered has to be quite large to help absorption. (The older versions of gel - more than 10 years ago- used to suggest using the leaflet as a template - roughly A4.)

Many women using gel are not in peri meno and I'm certainly not aware of any link with circadian rhythms.

Obviously women using patches get a steady drip drip over 24 hours from the patch reservoir.

Thanks, I'll check it out.

The circadian rhythm is important on postmenopausal women as well because it correlates with the circadian rhythm of cortisol which can be responsible for many affective disorders, like depression and anxiety, as well as PMDD in premenopausal women.

I think the future of Oestrogel, Sandrena and other gels (Estreva by Theramex) is to increase the amount of estradiol and decrease the volume pumped in each actuation so women can have a wider range of options without having to cover themselves in alcoholic gel.