Tirzepatide Combined With B12: Possible Safety Concerns

[Dos-Dox]

Sure, this looks like yet another move aimed at taking compounded tirz off the market. Even so, I figured I should share it here, since I've noticed some folks include B12 when they reconstitute. According to this open letter, the reaction between tirz and various vitamin B12 forms produces "significant levels" of an impurity.

If public health were truly their priority, you'd think they would name the impurity. But that's a separate rant.

Here's the Lilly open letter, plus a reel that offers some commentary on it.


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


View: https://www.instagram.com/reel/DVzA_2gj_6Q/?igsh=MTkyYTJ5MzV6N2U2Nw==

 

[CandyCap]

The announcement is provided below

 

[Chili777]

APC has issued a response:

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.*

That particular line is what caught my eye. So is patient welfare actually their priority? Or is the goal to line their pockets? And is this merely a tactic to hinder compounded options? Or does a genuine hazard exist?

 

[Chili777]

byefatlicia said:

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

That particular line is what caught my eye. So is patient welfare actually their priority? Or is the goal to line their pockets? And is this merely a tactic to hinder compounded options? Or does a genuine hazard exist?

Whatever those people declare it to be, that's the final word—and the bought-and-paid-for officials in Washington, the ones we call Congress, will trot over, kneel down for a scratch behind the ears, and carry out every instruction handed to them.

 

[HereKittyKitty]

byefatlicia said:

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

That particular line is what caught my eye. So is patient welfare actually their priority? Or is the goal to line their pockets? And is this merely a tactic to hinder compounded options? Or does a genuine hazard exist?

That phrase gets used to scare people into going along with things.

 

[conzopiriani]

byefatlicia said:

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

That particular line is what caught my eye. So is patient welfare actually their priority? Or is the goal to line their pockets? And is this merely a tactic to hinder compounded options? Or does a genuine hazard exist?

Money talks!

 

[Dos-Dox]

Lilly clearly has an agenda here, no argument from me on that. Still, because I’m aware that certain folks combine B12 with their grey market tirz, I figured this community would want to hear about the possible issue, even though it remains murky and poorly defined. Personally I don’t use tirz, but were I in that position, I’d likely lean toward injecting it apart from any B12 shot.

 

[byefatlicia]

Dos-Dox said:

Lilly clearly has an agenda here, no argument from me on that. Still, because I’m aware that certain folks combine B12 with their grey market tirz, I figured this community would want to hear about the possible issue, even though it remains murky and poorly defined. Personally I don’t use tirz, but were I in that position, I’d likely lean toward injecting it apart from any B12 shot.

Absolutely And thanks for the warning. The truth is none of us really knows. Either way, it's safest to treat this information as accurate, no matter what EL is trying to accomplish.

 

[Chili777]

byefatlicia said:


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.

Click to expand...

I'm not sure either. That rebuttal leaves plenty of unanswered questions too. Assuming it's accurate, what's the reason for putting out a press release instead of going to the regulators? Why keep the scientific community in the dark rather than letting them try to reproduce these findings?

Perhaps I'm revealing my own leanings here, but the way I see it, they're trying to cast suspicion on every compounding source—whether properly licensed or operating out of someone's basement. This isn't the first instance of EL pulling something like this. For years now we've been told about the deaths and devastation that would follow unless their own products were used, while they conveniently overlook that people continue to get great outcomes. Based on how they've acted before, nothing would surprise me from them.

 

[IshimaruKenta]

Just more fearmongering meant to safeguard their profits.

 

[byefatlicia]

Chili777 said:


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.

Click to expand...

I agree, though steering clear of the b12 is simple enough for us

 

[FarmgirlRebel]

Lilly is simply reverting to its usual approach, sowing FUD across the compounded market.

Clearly, my tolerance for risk runs higher — I no longer even use compounded. Actually... let me walk that back. Not long ago I got a Zepbound prescription, and it leaves me feeling as though I've betrayed my own principles (big pharma isn't exactly my thing).

Anyway, I'm still building up my Tirz stash in case I get cut off..and I'll add some Reta too, simply because it's an option.

 

[Jfrick11]

I'll take a balanced stance here and consider the larger picture.

The annoyance with large pharmaceutical companies and the sense that money always comes first is understandable. That said, the main safety issue deserves attention: there is no testing data on combining tirzepatide with B12, which means the outcomes are not known.

It also makes sense to ask why B12 gets included..... perhaps it's purely a promotional angle, or perhaps it serves to formulate a 'distinct' product that sidesteps patent protections. So yes, reasonable doubt exists on both sides, yet this doesn't alter the reality that the safety danger is genuine and shouldn't be dismissed simply because big pharma raises it.

Both things can definitely hold true simultaneously

 

[FarmgirlRebel]

Jfrick11 said:

I'll take a balanced stance here and consider the larger picture.

The annoyance with large pharmaceutical companies and the sense that money always comes first is understandable. That said, the main safety issue deserves attention: there is no testing data on combining tirzepatide with B12, which means the outcomes are not known.

It also makes sense to ask why B12 gets included..... perhaps it's purely a promotional angle, or perhaps it serves to formulate a 'distinct' product that sidesteps patent protections. So yes, reasonable doubt exists on both sides, yet this doesn't alter the reality that the safety danger is genuine and shouldn't be dismissed simply because big pharma raises it.

Both things can definitely hold true simultaneously

That's fair—there's merit on either side.

What makes me doubtful about this specific report is the lack of detail. It simply asserted something as fact, without citing a source or providing anything further. "we found this"—and that's all...I don't doubt they did find it, but they gave no indication of what was examined, the location, how long ago, where it came from, and so on.

 

[CandyCap]

FarmgirlRebel said:

Jfrick11 said:

I'll take a balanced stance here and consider the larger picture.

The annoyance with large pharmaceutical companies and the sense that money always comes first is understandable. That said, the main safety issue deserves attention: there is no testing data on combining tirzepatide with B12, which means the outcomes are not known.

It also makes sense to ask why B12 gets included..... perhaps it's purely a promotional angle, or perhaps it serves to formulate a 'distinct' product that sidesteps patent protections. So yes, reasonable doubt exists on both sides, yet this doesn't alter the reality that the safety danger is genuine and shouldn't be dismissed simply because big pharma raises it.

Both things can definitely hold true simultaneously

That's fair—there's merit on either side.

What makes me doubtful about this specific report is the lack of detail. It simply asserted something as fact, without citing a source or providing anything further. "we found this"—and that's all...I don't doubt they did find it, but they gave no indication of what was examined, the location, how long ago, where it came from, and so on.

On top of that, they never specify what "this" refers to. The whole thing is extremely unclear.

 

[Maximus]

A load of nonsense!

 

[Dos-Dox]

For those wanting a closer look, here is the preprint with the analytical findings:

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



Background In the U.S., compounded tirzepatide is sold in many places as fixed-dose mixtures that pair tirzepatide with different vitamin B12 analogs. These products are mass marketed across the U.S. and other countries as equivalent to FDA-approved tirzepatide products even...

Image unavailable


www.medrxiv.org

 

[lessthanhalf]

Dos-Dox said:

For those wanting a closer look, here is the preprint with the analytical findings:



View attachment 10676



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



Background In the U.S., compounded tirzepatide is sold in many places as fixed-dose mixtures that pair tirzepatide with different vitamin B12 analogs. These products are mass marketed across the U.S. and other countries as equivalent to FDA-approved tirzepatide products even...

Image unavailable


www.medrxiv.org

I appreciate you sharing that. I agree it was strange that Lilly's letter contained so little detail about what exactly they detected or what the implications might be. To summarize for anyone who hasn't seen it: they identified b12 attached covalently to tirzepatide molecules, at varying rates but reaching as high as 10%. Right now there is zero evidence about what consequences this does or doesn't produce. Still, it strongly implies that when b12 and tirz are combined, a substantial portion will react and bind together. What traits that resulting molecule possesses is a complete mystery. My takeaway is: don't mix them. It isn't safe. Possibly it just reduces tirzepatide's effectiveness by blocking receptor binding. Possibly it alters how the drug is metabolized. Possibly it raises immunogenicity. But absent any testing, there's no way to find out.

A lot of people cry "big bad pharma," yet the claim that compounded products might carry greater danger isn't false, and grey-market ones even more so. Tirzepatide that is legally compounded must at minimum satisfy certain safety requirements. However, plenty of clinics don't always use the legal versions. And the choice to add b12 during compounding proved to be an error, yielding legally compounded tirzepatide that contains a meaningful quantity of a combined molecule whose effects are entirely unknown. Grey peptides carry higher risk: no safety requirements exist, and mislabeling plus dosing mistakes do occur. For reasons that are somewhat difficult to grasp, it appears to happen less frequently than I'd expect, but the risks are still elevated, and unless you test each batch individually, you can't be sure your product is safe. Whether those added risks are acceptable is a personal call. In my view, for people with severe long-term obesity who can't afford the legitimate versions, the danger of going untreated is so great that it would outweigh any risk from grey peptides. Whether that logic extends to other groups is murkier, since there's no way to measure how often major mislabeling and major misdosing happen. The academic studies that test grey peptides draw from random sources and report very high likelihoods of either no active drug or heavily underdosed drug. But those studies seem built to emphasize the hazards, functioning as a kind of public health warning. That's not a bad goal, yet it doesn't match what I observe on this forum: serious dosing and labeling errors are rare, though they do occur.

 

[DjJoshua]

Dos-Dox said:

Sure, this looks like yet another move aimed at taking compounded tirz off the market. Even so, I figured I should share it here, since I've noticed some folks include B12 when they reconstitute. According to this open letter, the reaction between tirz and various vitamin B12 forms produces "significant levels" of an impurity.

If public health were truly their priority, you'd think they would name the impurity. But that's a separate rant.

Here's the Lilly open letter, plus a reel that offers some commentary on it.


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


View: https://www.instagram.com/reel/DVzA_2gj_6Q/?igsh=MTkyYTJ5MzV6N2U2Nw==

Here's the loophole I found... put them in 2 separate syringes...... Lilly will still take them to court, but at least it's not dangerous. lol......

Alliance for Pharmacy Compounding is calling BS on how aggressively Lilly is pushing this.

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

From what I can tell, after four years of widespread use there is no flood of patient harm reports specifically linked to the B12 mix (the APC CEO literally said “no alarming trend of adverse events”).

Beyond that, Licensed 503A and 503B pharmacies deal with incredibly complex and dangerous sterile compounding on a daily basis (chemo drugs, high-potency hormones, total parenteral nutrition that can kill you if messed up, etc.) without constant catastrophes. The notion that they all of a sudden can’t mix B12 without producing some terrifying mystery molecule that only Lilly’s lab is capable of detecting seems awfully convenient.