Her daughter died after taking a generic version of a lifesaving drug. This is what she wants you to know.
“ When I first learned that a critical medication for transplant patients — one that keeps them alive — had generic versions that might not be effective, I called a specialty pharmacist at a hospital in Virginia. Adam Cochrane had written a journal article about the problems with the generics.
The drug is called tacrolimus, and it keeps a transplant patient’s body from rejecting a donated organ. I was surprised to hear that Cochrane had several patients he thought had died in part because their generic tacrolimus hadn’t worked right.”
First of all, Regarding generics… for rapamycin, in Europe they only sell the branded version (I believe) the Pfizer Rapamune version. It’s also what is sold in Turkey. In the US and India it’s all generic versions of rapamycin.
But - this story is another drug entirely. Tacrolimus is unrelated to sirolimus/rapamycin. Its easy to get mixed up with a drug that is similar to rapamycin called Temsirolimus.
The fundamental distinction is that temsirolimus is primarily an antineoplastic agent (mTOR inhibitor) used in oncology, whereas tacrolimus is an immunosuppressant (calcineurin inhibitor) used in transplant medicine and dermatology.
And yes, some generics don’t have the same dose level and consistency as the branded drug produced in Europe or the US.
For longevity purposes, most of us probably shouldn’t care too much if our dose is slightly lower or higher in a given batch of medication because we really don’t know what the optimal dosing is for longevity with rapamycin right now. I’ve taken from 3mg a week to 28mg a week and noticed nothing different (though blood lipids went up at higher doses).
But for tacrolimus, and organ transplant patients, a substandard medicine could be fatal.
Oh, I’m well aware that these are different drugs. But I was under the impression that Pfizer recently stopped making branded sirolimus and at this point all we have are generics. My question had more to do with the reality that makers of generics have fewer incentives to strictly adhere to best manufacturing practices than branded drugs. That could make obtaining reliable rapamycin potentially less assured, as Siroboon seems to show. Let us hope that sloppy generics don’t extend to more rapamycin makers - so far Eris and Zydus seem fine (though weren’t there some issues with Dr. Reddy’s rapamycin in the US some time ago? I might be misremembering).
Yes - that is true.
And yes, Dr. Reddy’s has had issues in the past with recalls (on sirolimus).
Pfizer used to have a subsidiary called Greenstone that produced generic sirolimus.
Greenstone LLC was Pfizer’s long-standing wholly-owned subsidiary dedicated to authorized generics .
Role: It manufactured and marketed the authorized generic version of sirolimus (brand name Rapamune ). Because authorized generics are manufactured on the same production lines as the brand-name drug—often differing only in the label and packaging—they are chemically identical to the original proprietary formulation.
Current Status: In November 2020 , Pfizer spun off its Upjohn division (which included Greenstone) and merged it with Mylan to form a new independent entity named Viatris . Consequently, while Greenstone legacy products (including generic sirolimus) are still widely available, the corporate entity is now a subsidiary of Viatris, not Pfizer.