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.

This was mentioned either on the BMS website under the availability of HRT, or on a pharmaceutical website, a couple of weeks ago. Besins issued a statement about it.

It's absolutely nothing to worry about and is being done so the gel is available.

The reason for it is because of the shortage of packaging. Besins have reverted to using some older style packaging (no idea if this is a supply issue with the suppliers of the plastic cartons, or what.)

Over the years I've used gel, the packaging has changed at least 4 times. It used to be in a while and gold bottle, the same shape of the one on the right of your photo.

see here

thebms.org.uk/news/british-menopause-society-update-on-hrt-supply/

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.

I just started using the new packaging estrogel, I’ve notice my symptoms returning. I’m quiet sensitive to changes so can easily recognise there’s something not quite right. Wonder if they’ve changed the ingredients or strength? Has anyone noticed their symptoms returning?

Yes, same here. I am two weeks in and suddenly now having a bleed mid-cycle. This has not happened before. Insomnia has also returned with a vengeance.

Grateful though to @JinglingChristmasBells for the clarification about the new packaging. At least I know this is the legit product - albeit, it seems, one with variable results.

Oh wow, I thought it was just me. I was up till 3.30 last night getting dark brown random bleeds and having night sweats ( albeit milder ) again.

I thought it was just the packaging that had changed but maybe pp are into something here.

Yes I’m having trouble getting off & staying asleep, plus hot flushes returning and very moody. I’m going to contact my GP and see what she says. Was doing great on the other estrogel, no problems at all. I wish they’d stop switching our medications😡

Sorry to hear we are in the same boat, but also reassuring that I am not alone. This forum is hugely helpful.

The manufacturers have stated that the product is identical and it's only the shape of the bottle that has changed. This is pharma- there are very, very strict quality controls on all meds.

As I mentioned before, in the years I've been using gel, the bottle shape has changed several times and also the colour of the bottles. The gel is in a plastic pouch inside the rigid plastic bottle. So, even if the outer bottle changes, the inner pouch is the same.

If your symptoms are coming back it's nothing to do with a change of bottle, but more to do with your own peri needs / hormones shifting., as they do.
There is also a huge nocebo effect where you can imagine something is worse, because you are worried and expect it to be.

@Nanabear12 The gel is the same it's just the bottle that has changed. Talking to your GP is going to waste their time and yours. I have discussed this with my consultant (one of the top ones in the UK) and they say the product is the same, whatever the shape of the bottle.

Then why has my symptoms returned? There’s something not right with this batch, I’m not going to continue to use it if it doesn’t work, that’s a waste of my time and money, why should I suffer? I’d rather spk to my GP and try something else!

@JinglingXmasbells, I agree that variations are unlikely in such a tightly controlled product. However, something must account for the sudden deterioration in symptoms in so many of us (and while the nocebo effect certainly exists, I doubt it explains my particular case).

I was wondering whether the slightly shorter pump dispenser might release less product, and so actually weighed each pump this morning with a set of jewellery scales (result was negative - the pumps are still 1.25 grams, as per usual). Any ideas what else it could be?

@Nanabear12, from what I understood, Besins is still also using the old/regular packaging alongside this one. Before switching to an entirely new product, and risking all sorts of adjustment problems, it might be worth requesting a new Oestrogel prescription from your GP and then check with your pharmacy what packaging they are about to dispense the product in. If it's the new one, simply have your prescription filled elsewhere where they dispense the regular format. That's my course of action for now

I don't know what I can add, really @Cosmetichamster and @Nanabear12

Pharma is a very highly controlled manufacturing process. A drug has to go through many levels of quality assurance/ control before it's released. This will include everything from the raw ingredients to the final product.

I'm sorry that I can't shed more light on it, but having had at least 4, or maybe 5 different sorts of packaging over around 14 years, I've not noticed any difference. It's very common for symptoms to change during peri and that is the most likely reason, not a change of the type of plastic carton.

If you dismantle the empty bottle you will see the foil/plastic pouch inside. This is the same regardless of the outer rigid bottle.

If it's the new one, simply have your prescription filled elsewhere where they dispense the regular format.

The reason Besins are using the older style bottles is because of a lack of the new shape. I assume their supplier of the older bottles either had more back-stock so they acquired it, or they have been able to supply more of those bottles to fulfil demand.

Bottles and leaflets (and all the packaging), is often out-sourced and has nothing to do with the actual pharmaceutical manufacturing process or the quality of the drug in it.

It's really just like getting your pint of milk in a carton or a glass bottle. The milk's the same!

It will be nigh impossibly at the moment to insist on whichever shaped bottle you prefer, as pharmacies can't pick and choose. They take what is there, from their wholesalers.

@JinglingXmasbells, thanks for explaining - this makes perfect sense!
As for the ever-shifting goal posts of peri / menopause: boo hiss

@Cosmetichamster when you get to the end of a bottle, wrestle the cap off and take the inner thin plastic/foil tube out of the big plastic bottle. You'll see what it's like! It slowly 'contracts' as it's used up.

When there is a shortage of products (as there has been with gel over the years) it's often not the actual drugs that are scarce, but it can be supply issues with the companies who provide the leaflets, the packaging, etc.

The flagon style of bottle is relatively new, because the cylindrical one was used for years- first in white & gold , then in white & turquoise.

For those experiencing changes - have you had covid recently (or a covid jab?). Both right royally screwed up my HRT cycles and bleeding went all over the shop.

Apparently it is very common and they are trying to collate data on the effects of covid on menstruation and HRT regimes.

I’ve been using oestrogen for years successfully. In my last prescription I was delivered the Besins new bottles (white lids). After 2 weeks using them my hot flushes returned violently. I mean, this wasn’t feeling a bit warm. This was full on.

After a week of this I remembered I had a spare ‘old’ bottle lurking (blue lid). So I used this; and the hot flushes went again. The only difference was the bottles. Nothing else. No illness or lifestyle changes or anything.

I’ve read everything that has been said on this thread about how this can’t be possible, but I am in no doubt: what is being delivered out of the new bottles does not have the appropriate level of oestrogen.

Maybe this is because of what’s in the sachets inside them, maybe it’s because of whatever process is applied to the sachets in order to get them into the new bottles.

So my question is: what to do about this? Both in terms of alerting NHS to a potential pharma quality issue that will affect large numbers of women, and personally? I know now that once my blue top bottle runs out I will effectively not have oestrogen, because what I’ll get from the chemist (new bottle) is useless.

I’m so fed up with women being messed around like this.

If you think this is a quality control issue,

1 write to customer services at Besins and quote the batch number on the cartons (I have found them very helpful when querying supplies and they reply quickly. Email is on their website.)

2 Complete the Yellow Card, listing your reaction to the product

3 Return the item to the pharmacy and tell them what has occurred.

Quality control in pharmaceuticals is the highest there is in any manufacturing processes. If you feel there is an issue, they need to check their manufacturing process.

Yes, since my earlier post (I’m sitting up as son ill) I’ve contacted Besins (using the email [email protected]) & made a Yellow Card report (took 5 mins).

I’ll contact my GP on Tuesday & ask my prescription to be changed to Lenzetto. Also pharmacist.

I would urge anyone reading this who has the same problem to do the same. (Also I would suggest to anyone moving onto the new bottles to keep the box until you’re sure you’re ok- it has the batch number on it which you will need for a Yellow Card report.)

Please do report if you are affected! The idea that it would be a waste of a GP’s time to report an issue with the quality of a medicine really horrifies me. I think exactly the opposite: that it is by individuals taking action & reporting problems that quality control & consistency issues in medication can be identified & addressed. There’s a reason we have a Yellow Card system! And, if you’ve been prescribed something, you need it. HRT matters! If for some reason what’s being delivered isn’t working as it should, your GP needs to know, as does your pharmacist.

That's the one I've been using for a while.

I just find the whole thing baffling.

The 'new' style pump is the same as I used years ago (12 and more years ago) and it looks as if they have procured that shape from old stock perhaps.
The label has changed to blue rather than white/gold as it was years back.

I think the problem Besin's face is that meno symptoms change so much that it's nigh impossible to do a proper quality analysis of what's going on.

@Cherryann Have you tried the most obvious solution which is to increase the number of pumps to see if that works?

Hi Jingling! I already use 4 pumps (& have done for years) & would not want to increase this (also do not think I should have to do so if the issue is a problem with quality control, for obvious reasons).

I am 54 & my symptoms have been under control for a long time.

Do come back and let us know if you hear anything from Besins or anything about any differences.

I think the new bottles are part of the supply going out rather than a permanent change- it's so they can try to fulfil demand.