EFPIA Position paper for NDSRIs of beta-blockers and beta-agonists / ACE inhibitors / dihydropyridine

Dear all,

I would like to share this interesting EFPIA document about a possible interim AI for the beta-blockers and beta-agonists category. Here the conclusion:

In conclusion, a weight of evidence approach, together with the understanding that NDSRIs such as nitrosamines of β -blockers are structurally very different than the small potent nitrosamines that are currently being used as the default surrogates for setting AIs for nitrosamines, leads to the conclusion that nitrosamines of β -blockers are much less potent mutagens and their carcinogenicity potency is probably also much lower than the small nitrosamines. Until further data become available (e.g. from in vivo mutagenicity), it is proposed in the interim that nitrosamines of β blockers be controlled as non-cohort-of-concern mutagenic impurities at the TTC limit of 1500 ng/day.

EFPIA position-paper-for-beta-blockers-and-beta-agonists-10jan2023.pdf (238.6 KB)

Similar documents are also available for other categories of drugs for chronic use such as ACE inhibitors and dihydropyridine

EFPIA position-paper-for-nitroso-ace-inhibitors-20feb2023.pdf (742.2 KB)
EFPIA position-paper-for-nitroso-dihydropyridine-ccbs-20feb2023.pdf (236.5 KB)


Thanks for sharing. This is a noteworthy paper for anyone working with these molecules.