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BCG Shortage?
Hello Friends,
Just completed my 3rd BCG maintenance course (#21) only to learn from my Uro there is an apparent shortage of BCG. Has anyone else heard this and if so, do you have any further information? I’ve read there is only one maker in the US…Merck, and the other source, Sanofi, in Canada no longer produces BCG. Thanks!
12/15 – Diagnosed Ta HG, 1.5cm Pap, Focal CIS
3/16 – Began BCG following NCCN and SWOG guidelines
2/19 – Ta HG recurrence and CIS/Ta HG in right kidney/ureter
2/19 – Nephroureterectomy to remove right kidney/ureter
9/19 – BCGx33 completed
2/20 – Invasive HG urothelial pT2 in prostate stroma2 Replies-
A few years ago there was a severe shortage of BCG due to contamination in some of the manufacturing processes. So far we have not heard any official word of a shortage .
It is possible that the hospital pharmacy where you are did not have enough in stock .However with only one supplier left in the market and this being a biological product it is likely to be subject to shortages in the future . Please keep your ears open and let us know if you hear any additional information .
Sara Anne
Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society
Forum Moderator
Mike M,
I have not heard of a shortage, nor have I seen BCG listed as in short supply.
The FDA monitors shortages and requires makers to provide advance notice of shortages and discontinued biologicals.
“The Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) made substantial changes to section 506C of the FD&C Act related to reporting and addressing interruptions in manufacturing or permanent discontinuances of certain drug products. For example, FDASIA requires manufacturers of certain drug products to notify FDA at least 6 months prior to the date of the permanent discontinuance in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or, if that is not possible, as soon as practicable. Such drug products include those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. ..”
More info and updated list of shortages at:
https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/default.htm
At the bottom of the above webpage, there is a number for the FDA you can call to inquire.
Best
Jack
6/2015 HG Papillary & CIS
3 Years and 30 BCG/BCG+Inf
Tis CIS comes back.
BC clear as of 5/17 !
RCC found in my one & only kidney 10/17
Begin Chemo; Cisplatin and Gemzar
8/18 begin Chemo# 3
Begin year 4 with cis
2/19 Chemo #4
9/19 NED again :)
1/2020 CIS is back
Tried Keytruda, stopped by side effects
Workin on a new plan for 2021Sign In to reply.
