“Potential safety risks associated with tirz mixed with B12”

[Dos-Dox]

Obviously another tactic to get compounded tirz shut down, but I thought I’d post for everyone information regardless because I’ve seen some people use B12 as part of their reconstitution. This open letter notes that “significant levels” of an impurity is created as a byproduct of the reaction between tirz and multiple forms of vitamin B12.

Seems like if they really cared about public health, they’d tell us what the impurity is, but I digress.

Link to Lilly open letter and also a reel with some commentary about it.

https://investor.lilly.com/news-releases/news-release-details/open-letter-eli-lilly-and-company-warning-potential-patient

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[CandyCap]

Here is the announcement

 

[Chili777]

Here is the rebuttal from APC:

Statement of APC Chief Executive Officer Scott Brunner, CAE, on statements by Eli Lilly claiming an unknown impurity in sampled tirzepatide + B12 drugs

Statement of APC Chief Executive Officer Scott Brunner, CAE, on statements by Eli Lilly claiming an unknown impurity in sampled tirzepatide + B12 drugs

a4pc.org

 

[byefatlicia]

"The continued widespread distribution of untested compounded drugs is an unacceptable risk for patients.*

This statement right here gets my attention. So do they really care about the patients? Or are they trying to make more money? And is this just a strategy to slow compounded? Or is there really a danger?

 

[Chili777]

"The continued widespread distribution of untested compounded drugs is an unacceptable risk for patients.*

This statement right here gets my attention. So do they really care about the patients? Or are they trying to make more money? And is this just a strategy to slow compounded? Or is there really a danger?

It's whatever they say it is and their paid off government lackeys, also known as Congress, will come sit at their feet for a pat on the head and do whatever is asked.

 

[HereKittyKitty]

"The continued widespread distribution of untested compounded drugs is an unacceptable risk for patients.*

This statement right here gets my attention. So do they really care about the patients? Or are they trying to make more money? And is this just a strategy to slow compounded? Or is there really a danger?

This is the invoked phrase to generate fear and compliance.

 

[conzopiriani]

"The continued widespread distribution of untested compounded drugs is an unacceptable risk for patients.*

This statement right here gets my attention. So do they really care about the patients? Or are they trying to make more money? And is this just a strategy to slow compounded? Or is there really a danger?

Cha-ching!

 

[Dos-Dox]

I agree that Lilly’s motives are pretty clear. But again, since I know some people add B12 to their grey market tirz, I thought this community might at least like to know about the potential, even despite how unclear and undefined it is. I don’t take tirz, but if I did, I’d probably consider taking it separately from a B12 injection.

 

[byefatlicia]

I agree that Lilly’s motives are pretty clear. But again, since I know some people add B12 to their grey market tirz, I thought this community might at least like to know about the potential, even despite how unclear and undefined it is. I don’t take tirz, but if I did, I’d probably consider taking it separately from a B12 injection.

Totally And I appreciate the heads up. We truly don't know. And it's best to take this info as fact, regardless of EL's agenda.

 

[Chili777]

Totally And I appreciate the heads up. We truly don't know. And it's best to take this info as fact, regardless of EL's agenda.

I don't know. The rebuttal raises a lot of questions as well. If this is true, why issue a press release and not contact the regulatory authorities? Why not alert the scientific community to see if these results can e replicated?

Maybe my bias is showing, but to me it appears they are instilling doubt about all compounding outlets, licensed or run out of a basement. This isn't the first time EL has done something like this. We've already heard for years about the death and destruction that will occur unless their own preparations are used, and they ignore the fact that people are still seeing excellent results. Given their past behavior, I put nothing past them.

 

[IshimaruKenta]

Anything to spread FUD that protects their bottom dollar.

 

[byefatlicia]

I don't know. The rebuttal raises a lot of questions as well. If this is true, why issue a press release and not contact the regulatory authorities? Why not alert the scientific community to see if these results can e replicated?

Maybe my bias is showing, but to me it appears they are instilling doubt about all compounding outlets, licensed or run out of a basement. This isn't the first time EL has done something like this. We've already heard for years about the death and destruction that will occur unless their own preparations are used, and they ignore the fact that people are still seeing excellent results. Given their past behavior, I put nothing past them.

Agree, but it's easy enough for us to avoid the b12

 

[FarmgirlRebel]

Lilly just going back to their standard playbook, creating FUD in the compounded marketplace.

My risk tolerance is obviously higher, since I don't even bother with compounded anymore. Well...I take that back. I was recently prescribed Zepbound and feel kind of like I've sold out to my principals (not a big pharma fan).

Oh well, still stockpiling my Tirz just incase I'm dropped..gonna throw in some Reta as well, just because I can.

 

[Jfrick11]

I'm going to go middle ground on this one to look at the big picture.

I get the frustration with big pharma and the feeling that everything is profit driven. At the same time, I think it’s worth looking at the core safety concern here: mixing tirzepatide with B12 hasn’t been tested , so the effects are unknown.

It’s also reasonable to wonder why B12 is being added..... maybe it’s just a marketing boost, or maybe it’s a way to create a ‘different’ compound that can be sold without infringing on patents. So yes, there’s valid skepticism on both sides , but it doesn’t change the fact that the safety risk is real and shouldn’t be ignored just because big pharma points it out.

Two things can certainly be true at the same time

 

[FarmgirlRebel]

I'm going to go middle ground on this one to look at the big picture.

I get the frustration with big pharma and the feeling that everything is profit driven. At the same time, I think it’s worth looking at the core safety concern here: mixing tirzepatide with B12 hasn’t been tested , so the effects are unknown.

It’s also reasonable to wonder why B12 is being added..... maybe it’s just a marketing boost, or maybe it’s a way to create a ‘different’ compound that can be sold without infringing on patents. So yes, there’s valid skepticism on both sides , but it doesn’t change the fact that the safety risk is real and shouldn’t be ignored just because big pharma points it out.

Two things can certainly be true at the same time

I agree, both can be valid.

My skepticism from this particular report is they didn't lay out any further information. Just made a statement of fact, no source, or any other information. "we found this" and nothing else...I'm sure it is true, they did find it, but no other information as to what was tested, where, how old, source etc.

 

[CandyCap]

I agree, both can be valid.

My skepticism from this particular report is they didn't lay out any further information. Just made a statement of fact, no source, or any other information. "we found this" and nothing else...I'm sure it is true, they did find it, but no other information as to what was tested, where, how old, source etc.

And they don't even tell what "this" is. They are sooo vague.

 

[Maximus]

Bunch of bunk!

 

[Dos-Dox]

The preprint analytical data for anyone who’d like to read in more depth:

A Novel, Widespread Impurity in Mass-Compounded Tirzepatide/B12 Products: Patient Safety Implications

Background Compounded versions of tirzepatide are widely available in the U.S. in the form of fixed-dose combinations of tirzepatide and various analogs of vitamin B12. These combinations are mass marketed in the U.S. and other countries as comparable to FDA-approved tirzepatide products even...

www.medrxiv.org

 

[lessthanhalf]

The preprint analytical data for anyone who’d like to read in more depth:

A Novel, Widespread Impurity in Mass-Compounded Tirzepatide/B12 Products: Patient Safety Implications

Background Compounded versions of tirzepatide are widely available in the U.S. in the form of fixed-dose combinations of tirzepatide and various analogs of vitamin B12. These combinations are mass marketed in the U.S. and other countries as comparable to FDA-approved tirzepatide products even...

www.medrxiv.org

Thanks for that, it did seem odd that the letter from Lily had no real information in it about what they detected and what it might mean. For those who have not read it, they found b12 covalently bonded to tirzepatide molecules, to varying degrees but up to 10%. At this point there is no evidence at all of what effects this might or might not have, but it certainly suggests that if you mix b12 and tirz a significant amount will react and combine, what properties this combo molecule has are unknown, but to me it says do not combine them, it is not safe. It may simply make the tirzepatide less effective if it interferes with binding to the receptor, it may change its metabolism, it may make it more immunogenic, but without any testing there is no way to know.

Despite lots of people saying big bad pharma, they are not wrong that compounded versions could be more dangerous, and grey ones even more so. Legally compounded tirzepatide at least has to meet some safety standards, but various clinics do not necessarily use the legal versions, and the decision to compound with b12 turned out to be a mistake, creating legally compounded tirzepatide with a fair amount of a combination molecule with completely unknown effects. Grey peptides are more dangerous, there are no safety standards, mislabelling and dosing errors do happen. For some fairly hard to understand reasons it seems to happen less often than I would guess, but there are added risks, and without individual batch testing there is no way to be certain your product is safe. Whether these added risks are worth taking or not is an individual decision. I think for those with severe longstanding obesity unable to afford the legit versions, the risks of no treatment are so high that it would overwhelm any risk effects from grey peptides, but whether that applies to other groups is more complicated, given there is no way of determining the incidence of major mislabelling and major misdosing events. The academic papers that exist on testing grey peptides use random sources, and find very high probabilities of no drug or very underdosed drug, but they do seem designed to accentuate the dangers as a sort of public health awareness issue, which is not a terrible idea but it does not correspond to what I see on this forum, which is that serious dosing and labelling errors are uncommon, but do happen.

 

[DjJoshua]

Obviously another tactic to get compounded tirz shut down, but I thought I’d post for everyone information regardless because I’ve seen some people use B12 as part of their reconstitution. This open letter notes that “significant levels” of an impurity is created as a byproduct of the reaction between tirz and multiple forms of vitamin B12.

Seems like if they really cared about public health, they’d tell us what the impurity is, but I digress.

Link to Lilly open letter and also a reel with some commentary about it.

https://investor.lilly.com/news-releases/news-release-details/open-letter-eli-lilly-and-company-warning-potential-patient

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I got the work around.. sell them in 2 different syringes...... THEN Lilly WILL sue them but it's safe. lol......

Alliance for Pharmacy Compounding call bullshit on how hard Lilly is pushing this.

https://a4pc.org/news/statement-of-...own-impurity-in-sampled-tirzepatide-b12-drugs

As far as I know there is zero flood of patient harm reports tied specifically to the B12 mix after four years of widespread use (APC CEO literally said “no alarming trend of adverse events”).

On top of that Licensed 503A and 503B pharmacies do handle insanely complex and dangerous sterile compounding every day (chemotherapy drugs, high-potency hormones, total parenteral nutrition that can kill you if fcked up, etc.) without constant disasters. The idea that they suddenly can’t mix B12 without creating a scary mystery molecule that only Lilly’s lab can see feels convenient.