🇺🇸 FDA - Fiscal Year 2024 Generic Drug Science and Research Initatives Public Workshop

First of all a lot of thanks for the responce.
At the current stage of knowledge I agree that its difficult to predict how much of the nitrosamines are accumulating in the skin and do the enviromental nitrosamines in the air for example could induce phototoxic/ carcinogenic effects.
However independet from that we cannot exclude that scenario at the moment.
The problem is also related to the polimedication and the high dosis of nitrosamines in the contect of policontamination, that could have additional photocarcinogenic effect yogethwer with the UV induced skin carcinogenesis for example?
As the FDA postulated recently in only one tablet of metformin the dosis could be elevated

more tha 5 times only in one tablet!
We have patients taking till 6 tablets for example, that means 30 timed elevation of the acceptable daily intake dosis for nitroamines in metformin…
Additional the same patient was taking 3 potentially contaminated drugs listed in the fda bulletin from 2023 ? Thats a genotoxic cocktail for sure and we have in this patients 13 till 16 skin cancers in UV light exposed areas…some of the papers are published, others under press here.
Additionally what would be and could be the explanation that the nitrosamine induced mutations - espeecially here the tobaccos specific nitrosamines are affecting p53 and the RAS oncogenes family, …same targets thatw have been seen till now as responsible for all types of skin cancer? the overlapping of these genes could be the start of begining to resolve some aspects of the skin carcinogenesis of skin cancers pathogenesis…
Its more than important that these have to be clarified and thematized on the meeting…thats a new starting point

other point is : labelling must be for each and every drug. Secondary test also, 2 or 3 months later. Its not adequate that the end consumers are taking mutagens and carcinogens within the mono or polimedication and thay are not even informed about that in the last 30-40 years.
Clarification could only result after labelling of the content and clarifying the carcinogenic/ mutagenic and photocarcinogenic effects of eacha and every nitrosamine or NDSRIs…
thats the most appropriate… ???

I completely agree ,BUt we have patients that have up to 7-8 medications since years intake, which has been listed in the FDA’s list !
The statement is also from the fda that in even one tablet metformin we can have 5 time elevated nitrosamine concentration!!!

If we can mess this in blood and skin- would
Be nice!

There is no doubt that we have elevated concentrations ! 3 times 2 tablets metformin - than we have 30 times elevate NDMA concentrations daily!!!
Wonder than why we have skin cancer! I have those type of patients and will try to publish this !
Additionally this patients take 2-5 medications, potentially contaminated , listed in the fda list…

Great @gregorjug - Good to know from patient perspective. Interesting you have patient based data. I look forward for this publication data.

By the way does NDMA triggered any photogenotoxicity in humans?

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Will send papers !
Here some data from me also regarding the issue:

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We have a huge amount of clinical cases

Soon…

A good question for NDMA ?!

Phototoxicity?

When the answer is yes- this could
Change history in medical science and skin cancer all pathogenetic concepts!

I believe that the answer is: YES!

Time for revolution- now or never ever!:handshake:

Appeal is to each and every scientist : check of nitrosamine phototoxicity !
There is a huge overlapping between the work list of medications that cause phototoxic reactions and the fda list for
Medications, contaminated with nitrosamines!

More than ideal to be checked !

Now

Who could be more suitable than you to take on this presentation? From day one, you’ve been deeply engaged in the intricacies of this group, participating in discussions, raising awareness, offering guidance, and more. You will represent us flawlessly. Much confidence in you.

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Now event material is available. Please check it. :laughing: :laughing: :laughing:
https://www.fda.gov/media/177881/download

May 20, 2024

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We had our last planning meeting today, and I want to once again encourage everybody to participate. The public comments presentations and the lineup of speakers promise to bring a very insightful discussion.

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