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.

That’s interesting…Are you talking about just the difference in shape between new cylinder and old shape with blue lid?

Yes. I had no issues with the old bottle. I only found out other women were having the same issues on here after six weeks of feeling utterly rubbish.

I raised a yellow card about this. I suggest anyone who has experienced this same issue with the difference between bottles also raises one then we have more chance that it will be investigated.

yellowcard.mhra.gov.uk/

Yes, me too for about 6 weeks too. How is the Sandrena, is it better or too soon to tell ? 🤞🏻

@Vicci6 Too early to tell. I’ve been on it less than a week.

Hi. I’ve got the new bottle and I’m dreading using it, my friend said her symptoms came back. It’s definitely worth filling the yellow card in, but because the ingredients are the same Besins will say it’s all okay, the same as they did with the bottles being manufactured in different countries. We’re the ones using it not them so maybe they should do some trials to see, we can’t all be wrong.

Thanks for this. It seems to confirm my own experience. The last two prescriptions I’ve had have been the original packaging but I’ve had to check each time before putting the request in, which is a hassle. Hopefully, Besins will get the message.

@Vicci6 Been on Sandrena almost two weeks now and starting to feel more normal again. Only on 0.5ml this month but going up to 1ml after this first cycle. Honestly, a MASSIVE improvement.

Hi,
Someone flagged this post to me in another post.

I have been experiencing irritated skin (chin only, under the skin, no visible irritation), very sore boobs, and spotting since a few weeks. It feels as if my HRT has suddenly stopped working. I am currently on bottle 2 of my batch of 3, which I purchased in December. I have attached pics of the bottle and batch no. I live in Belgium. As you can see my packaging is also different. I'm completely confused.

I was told to stop HRT for a week. My ob/gyn said chances are that a follicle developed causing the spotting, although it's more of a period at this point. Sore boobs feel better, skin irritation has gone. VA seems to be returning with a vengeance. Have an appt with my consultant on 4 April, am trying to get one earlier.

What a hassle this is.

I thought that sore boobs and spotting were more symptoms of too much oestrogen.

Hi sorry to hear this. If you have instagram there’s information about this green square lot / batch beginning with 1 and orange square beginning with 7. When women have had the green square bottle their symptoms have come back, as did mine and many friends, I upped my dose to 4 pumps and it rectified the issue until I was able to get the orange square bottle. Also women had issues with Oestrodose the parallel import that also had a green square, so maybe just a coincidence who knows but Besins are saying same ingredients (which none of are saying they aren’t), but when they are coming from different manufacturers there has been issue ‘but’ there is now a spanner in the works the new shaped bottle has no coloured square and women are having issues with lot/batches beginning with 7, I’m yet to start any new shaped bottles. I would up your dose if you’re not on four already. Good luck.

I am on 1 pump per arm per day. Lowest dose.

Sorry, this was for @RestingMurderousFace.

I think the dosage is slightly less in the new bottles. I used one with the new bottle and hot flushes in the night returned. I didn’t think much of it but have since found an old style bottle that I’ve been using - I had 3 tearful, irrational and hormonal days that only happen when my HRT dose changes, and now I’m back to my usual self with no hot flushes. When I look at what’s dispensed from the old bottle, it looks like there’s slightly more gel dispensed than with the newer bottles…

I have noticed when I’m near the end of a bottle it doesn’t dispense as much gel, and the pump is slower to release. Although they say this doesn’t happen, but it does with everything else that is pump dispensed.

I have sent a mail to Besins. Am waiting for their answer (pharmacovigilance).

I raised a yellow card re the differences between the old and new bottles as my symptoms definitely came back with the new bottle. I had to increase my pumps from 2 to 3. Now I've gone back to an old bottle, I only need 2 pumps again. Something is definitely different!!

However, I have just had a reply from Besins and this is an extract (they have sent me their detailed investigation report also - if anyone is interested, please send me a PM with your email address and I'll share it with you). This is the summary from Besins:

Following your complaint, Besins Healthcare Global Quality initiated an extensive investigation of the above batch of Oestrogel pump‐pack. This has now been completed and the investigation report is attached for your reference.

Following complaints for consistency and lack of efficacy of the above batch of Oestrogel pumppack, Besins Healthcare Global Quality has not identified any deficiencies regarding the ingredients, the manufacturing process, the equipment, or the testing methods. Therefore, we have concluded that this product is of an acceptable standard and is fit for purpose.

Besins Healthcare are aware that some patients experienced a return of their symptoms and have been investigating those reports to find any possible causes to the issues reported. Our investigation has not identified any root cause with the product that could be responsible for your symptoms returning. We understand this doesn’t explain the return of symptoms and we will continue to seek answers as to why this happens with some people and not others.

I had the same response to mine. I'm hoping if we flood them with yellow cards they'll have to get their finger out and do some proper research - starting from the position that maybe there IS an issue rather than wanting to maintain the status quo / business as usual.

I have found my people! The new (old) style bottles brought all my symptoms back! My GP blamed it on my 45th birthday and upped the dose. That has helped but not to the extent it should. I was hoping it wasn't the bottle but looks like it most likely is. Either the product isn't the same or the pump measurement is different or transportation is causing degradation. Either way it's hell!

The good news is my latest prescription in March I got the conical bottle and was so relieved! Will be checking for this bottle henceforth before I accept my prescription.

I've just got my first dispenser of Oestrogel, so I've read this thread with interest. My pack doesn't have any squares next to the batch number at all. The batch number starts with a 7. The leaflet says manufactured in Belgium or France. Would this be the 'good' one or the 'bad' one?

Would have said good if begun with 7, and they were until the new bottle came about. So keep us posted.

Well I've used the first dose this morning. A very thick blob like hair gel, so I presume the better stuff.

They all look the same, feel the same, smell the same. Just don't work the same. Time will tell..

Lol 😂 The best thing I have ever read about it.

It will depend on who is in charge of the gel production now, the original Delpharm or Besins.

The good old gel was manufactured by Delpharm, a CDMO hired by Besins.

Now, Besins has re-acquired the manufacturing plant in Dogenbros, Belgium, from Delpharm, and Besins is the sole producer.

If Besins has kept the Delpharm team, the cylindrical bottles with batch numbers starting with 7 will be the same as the conical bottles with the orange square 🟧.

If Besins has hired its own team, they will produce the same gel as the conical bottles with the green square 🟩, which they had been producing at the Montrouge plant in France.

One would think they would have the same formula, but the pharmaceutical industry has secrets about production chains. I doubt Delpharm has the same suppliers as Besins. So, different sources of raw materials, different estradiol preparations.

I had a problem with this last year and reported it via yellow card. Got a “there’s not a problem with anything”response from Besins as I see everyone does. Since then it happened again. So I persevered and went through hell until my next prescription- back to a different person ( sane with no anger issues 🤣) with that batch. Then my last prescription (Jan 2023) I noticed a change and contacted my private meno clinic where I get testosterone and got a prescription for oestrogel there. Within a day of being on that one (privately bought) I was feeling much better. Now I’ve got my prescription this month (April 2023)from my gp & standard chemist - completely different bottle (cylindrical) and it’s definitely dispensing less and runnier. I can feel my irritable mood and anger rising. This is NOT a nocebo effect - it’s happening too randomly and too often. Nothing else in my life is changing and I don’t have a womb any more so no interference from progesterone. It’s incredibly frustrating and I urge everyone to report it via yellow card system because if we don’t highlight it they can’t sort it out. My hubby is begging me to get a prescription from the private clinic as he knows we all suffer when this happens! 😩Not sure whether to 🤣or 😢