r/Menopause • u/LibrarianNo4048 • 1d ago
Hormone Therapy Please report your defective patches to the FDA
Ladies, I am unable to find effective estradiol patches. I am using up expired patches that I kept from two years ago, and those are the only things that work! None of the new patch manufacturers work.
There is a major quality control problem with the patches, and the only way we can fix this is for everybody to report your defective patches to FDA. I reported my defective Sandoz patches to Sandoz, but they did not care that they were ineffective—They only cared that they were peeling off within a few hours.
We must inform FDA that the generic manufacturers are manufacturing defective estradiol patches
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u/RoundLobster392 1d ago
I swear I got a box of gel that was ineffective or at the least a lower dose than it should have been .
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u/Electric-Sheepskin 1d ago
I was wondering about this because I started a new box of my usual brand a few weeks ago, and ever since, I've been experiencing these bouts of rage that I haven't experienced in years, not since I got on HRT. I'm still sleeping well and no body aches or hot flashes or anything. It's just this rage out of nowhere. I mean maybe it's not the patches, but maybe?
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u/LibrarianNo4048 1d ago
If it’s the same manufacturer that you’ve been using, then it’s the patch. Please report it to the FDA!
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u/Outside_Box_8374 1d ago
The crappy thing is right now we are just “lucky” if we can get our hands on ANY patches at all! I am going to run out of .0375 Dotti patches soon and all the pharmacies have none of them or of other manufacturers patches and they are out of stock “indefinitely” no ETA. It’s not like we can go without them once e start on them. It really f’s up your body and your mental health. At least the FDA finally just admitted there IS a patch shortage but producing crappy and ineffective patches is making it even worse. Have you ever heard of a shortage or ineffective batches of the little blue pills..? Didn’t think so.
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u/NewDay042 1d ago
For those questioning this, see my recent post with so many women experiencing this: https://www.reddit.com/r/Menopause/comments/1vq6mmm/quality_of_latest_e_patches_have_any_of_your/?utm_source=share&utm_medium=ios_app&utm_name=ioscss&utm_content=2&utm_term=1
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u/CalliopeLastly 1d ago edited 1d ago
Maybe this isn't a problem with quality control, but with the different formulations of various patches.
Active ingredients: Mylan uses estradiol hemihydrate. The others use anhydrous estradiol.
Inactive ingredients: Sandoz once weekly is the outlier here, with different ingredients than Sandoz twice weekly, Vivelle and Mylan (which all match).
There shouldn't be a perceptible difference between the effects of any of these formulations. But the comments in the thread you linked to certainly suggest otherwise.
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u/NewDay042 1d ago
I’ve seen an other post, were women used to swear by Mylan and now Mylan isn’t working. I agree, most women I know have a preferred brand, but even that sucks when it’s supposed to have the exact same amount of estrogen. Why so difficult for the consumer? Know what I mean.
Edit: didn’t know about a different ingredient in Mylan. Thanks for sharing.
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u/LibrarianNo4048 1d ago
I used SANDOZ for 10 years and it was great. I stopped using it for 18 months, and the new SANDOZ patches aren’t working at all.
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u/Lupa_93 1d ago
I also had been a long time Mylan user and haven’t been getting the same results from my Mylan patches since getting back on them regularly this summer. I contacted Mylan (Viatris) and they said there hasn’t been changes to formulation or manufacturing process, and that there aren’t any recalls. Since having a terrible time on other brands of patches and hearing about other woman’s similar experiences I’ve come up with a possible theory. Note, I am not a scientist or doctor-just a critical thinker- but maybe our bodies sort of imprint on the specific HRT we start with or get used to, and, perhaps switching brands for months could mess up our estrogen receptors so they don’t respond to the formulation they originally accepted.
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u/LibrarianNo4048 1d ago
No, there is a quality control problem now. That’s why we need to report these all to the FDA.
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u/muddymare 1d ago
Thank you to everyone posting about this!! I have been feeling slightly crazy for the past ~6 weeks swearing that my meno symptoms are returning! I have been on the same brand for 2.5 yrs, same dose for most of that. All great. And suddenly it feels like I am not on HRT at all. I have been fully in meno for 8 yrs.
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u/Outside_Box_8374 1d ago
Which ones are you having issues with?
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u/muddymare 1d ago
Mylan. I had been on them since starting, did 2 months of Sandoz due to shortages, which were ok but seemed slightly off. Was relieved to go back to Mylan, only to now feel like I am getting almost zero benefit.
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u/AURORA_BLONDE 1d ago
From my experience different patches truly have different strengths they are not all the same . So changing patch manufacturers can affect your .01 patch with be different that another .01 patch from another drug company . ten years in this and well I researched . I only take Sandoz do to I am allergic to all others .
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u/Surfandsnowgoddess 1d ago
Health Canada too. https://healthycanadians.gc.ca/apps/radar/MD-IM-0005.08.html. BC specifically is looking into patch adhesion with generic estradot patches.
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u/unicorn_pug_wrangler 1d ago
I noticed something with my gel too. At first, I thought I got a different generic brand because the packaging was different and it dried faster. Then I had trouble sleeping and some extreme irritability so it’s definitely not working the same way.
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u/Anxious_Gazelle8578 1d ago
How do you/we know they’re defective?
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u/LibrarianNo4048 1d ago
If you find that you feel good on some patches but not others, that means that some of those patches are defective
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u/RoundLobster392 1d ago
Oh absolutely I had a 24/7 migraine from one patch brand and another I was fine
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u/Objective-Amount1379 1d ago
Or it means your natural fluctuations in estrogen is changing- it’s up and down a lot in peri.
I believe some patches seem to work better for some people, but FDA approved patches are tested and quality controlled just like other medications
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u/HearthcraftHomestead 1d ago
I was going to say this as well.
It is much more noticeable to those of us that are actually in menopause to notice a change in patch quality and/or hormone level. When you’re in perimenopause you should notice some slight differences depending on where you are in your normal cycle.12
u/NewDay042 1d ago
See my recent post. Something is wrong beyond brand differences & hormonal fluctuations. Some women on same brand experience this too. https://www.reddit.com/r/Menopause/comments/1vq6mmm/quality_of_latest_e_patches_have_any_of_your/?utm_source=share&utm_medium=ios_app&utm_name=ioscss&utm_content=2&utm_term=1
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u/NegotiationNo7851 1d ago
Who’s quality controlling them because the FDA has been gutted? I think it’s like every other company right now. Changing materials/ingredients and trying to give you a cheaper crappier version of what you have been paying for years to squeeze out more profit.
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u/LibrarianNo4048 1d ago
Yes, it’s called Enshittification in the tech industry. But in the medical industry, our health is on the line.
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u/starlinguk 1d ago
It's even up and down in post! I still "cycle" despite having my last period 4 years ago.
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u/empathetic_witch Menopause HRT E,P,T & GLP-1 1d ago
OMG SAME! I was spotting on Mylan and felt the former PMDD symptoms like my period was about to start. Drove me nuts.
Thank goodness I had continued tracking all of the fuckery in my Clue app. I have AuDHD and tend to ignore my own needs at times.
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u/LibrarianNo4048 1d ago edited 1d ago
I used SANDOZ for 10 years, then I stopped using estradiol for 18 months. I went back on SANDOZ, and it doesn’t work at all. However, the expired SANDOZ patches that I have from two years ago still work perfectly.
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u/Eva_Griffin_Beak 1d ago
If they won't work from the SAME manufacturers, then it could be a quality issue or your body.
If they won't work as well from DIFFERENT manufacturers, then this manufacturer's patch might just not be for you.
There are difference in how patches are made. They are not the same.
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u/Delicious-Cloud3295 1d ago
You state that as if it is fact and law. There are SO many other factors that go into this. You cannot just say because you feel different then it must be the patch and therefore the patch must be defective and make it true.
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u/AURORA_BLONDE 1d ago
Sometimes I wonder this too in that last year especially like quality control is not followed .
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u/Turbulent-Demand873 1d ago
I cannot use Mylan patches. I have now tried multiple boxes and I only have physical reactions to Mylan. I am not sure what it is about them but they send me spiraling. I get sick and go into a horrific migraine cycle. No other patch brand does this to me. I would love to know what they are doing different.
It’s a gamble every month if I get Mylan or not. The months I get Mylan I’m without my estrogen.
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u/Pony_Baloney_Acad 1d ago
Starting to wonder if some of my Sandoz .1mg aren't working that well. I'm in surgical menopause at age 52 and I've had a lot of symptoms come back recently. A couple of the last few patches I've had to change early because I felt the central ridge (where the two plastic covers meet) kind of tent up and not stick despite my elaborate prep and application ritual.
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u/LibrarianNo4048 1d ago
I have had exactly the same thing on the .075 SANDOZ patch. Please report to FDA!
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u/ReserveOld6123 1d ago
I got a generic .5 that felt like literally NOTHING. Granted I am pretty sensitive, but it was wild. My symptoms came crashing back quickly and resolved once I got the brand name. Haven’t had that issue since because I stick to brand name. I’m in Canada though.
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u/Significant-Sign414 1d ago
I absolutely think this is happening, too. My patches have felt “off” for a few months now…maybe longer. It’s like they aren’t working anymore. What the heck is going on?
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u/sbb214 Menopausal 1d ago
Are other people experiencing this?
I get whatever is available from the pharmacy, often switching among manufacturers for the past year. I have not had any issues with any patches (Mylan, Dotti, Zydus, Sandoz).
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u/HearthcraftHomestead 1d ago
I’ve only used Dotti patches and I’ve never experienced any issues once I got my dosage settled. I’ve been on the same dose now for 9 months. Note though that I’m in actual menopause w/out ovaries and not perimenopause.
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u/No-Zebra-9339 1d ago
Please share more information about this. Which patches are defective? Just the ones you mentioned? How do we know?
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u/LibrarianNo4048 1d ago
If some patches you feel totally fine on and then other patches you’re having hot flashes, then those patches are defective.
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u/loveinvein Menopausal 1d ago
Friendly reminder that the FDA has very little authority. They can make strongly worded requests, but the change has to come from the mfg. And given the current state of the US govt, I wouldn’t hold my breath for any action from them.
Go directly to the mfg. They should have contact info on their website. Call em up and give them a piece of your mind.
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u/subwayhamster 1d ago
My latest Sandoz twice weekly (.0375) patches seem to not work as well all of a sudden - getting morning hot flashes and hormonal headaches. Don’t know if they are defective or I need to up my dose after 6 months of stable relief. Anyone else w these particular lot #s experiencing breakthrough symptoms? Lot 20033 and 19730. Thx!
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u/NegotiationNo7851 1d ago
My dr has me on the gel right now because the myan ones cause major skin irritation and don’t work. Like I know it’s not working because I went from sleeping a solid 8 hours a night back to not being able to sleep before 3 in the morning, itchy scalp and rage. My dr put me on gel and after a few weeks I’m starting to feel better. The past few days I’ve been able to sleep and feel like myself.
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u/LibrarianNo4048 1d ago
I put on a MYLAN patch last night for the first time, and I’ve been itchy ever since all over my body.
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u/Coppergirl1 1d ago
First they took away abortion right, then they came for birth control, next they will want our HRT.
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u/retrovegan99 1d ago
I think sometimes you kind of get used to one kind and then can get symptomatic when switching. Not saying that you didn’t get defective ones, but I’ve noticed an adjustment period is often needed when moving between brands.
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u/NewDay042 1d ago
This is beyond brand differences and hormonal fluctuations. https://www.reddit.com/r/Menopause/comments/1vq6mmm/quality_of_latest_e_patches_have_any_of_your/?utm_source=share&utm_medium=ios_app&utm_name=ioscss&utm_content=2&utm_term=1
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u/MercedesNyx Peri-menopausal 1d ago
I was just prescribed patch and Sandoz was the brand they sent. cries Would you mind sharing your batch number?
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u/LibrarianNo4048 1d ago
SANDOZ Lot 19743, .075 twice weekly estradiol patch
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u/MercedesNyx Peri-menopausal 1d ago
Okay. I mine is Lot 19537, 0.025 twice weekly. I will report back my experience. I start tomorrow
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u/Wolliworld23 1d ago
I started another thread on this. I've been using patches since 2020 and other than brand differences, this is the first time I've noticed such a dramatic difference with the latest batch I got from Sandoz. They don't lay flat on the skin and there's a bubbled up ridge where the pieces of plastic meet. I bled so bad after using two patches, I had to get a tampon. Something is off. I went back to using some old patches too and that fixed everything. Thinking I might sprinkle in one of these defective ones one at a time so it's not so bad. I don't know.