Leprosy Mailing List – January 30 , 2021
Ref.: (LML) Rifampicin warning
From: Wim van Brakel, Amsterdam, the Netherlands
Hallo Pieter,
I would like to add one comment concerning the message from Dr Ruth Butlin. The interim advice from the ILEP Technical Commission (ITC) was not meant to be a warning, but a response to concerns raised about the nitrosamine impurities discovered in rifampicin in 2020. The intention is to put people's minds at ease.
The key message is that the level of these impurities is still very low, especially considering the limited number of doses of rifampicin consumed during MDT and particularly as part of SDR-PEP. The concerned authorities (WHO, US Food and Drug Administration and the European Medicine Agency) agree that there is no reason to discontinue MDT or PEP programmes. The nitrosamine impurities are being investigated further by these agencies and manufacturers have been instructed to test all rifampicin batches that are currently produced. So far, all but one of these test results show that the impurity levels are below the maximum level recommended by the US FDA (5ppm).
The ITC will continue to follow the developments closely and in close collaboration with WHO GLP and Novartis. The most recent news indicates that the production of rifampicin without elevated levels of nitrosamine is likely to commence sometime around mid-2021.
Kind regards,
Wim van Brakel
Chair ILEP Technical Commission
Wim van Brakel
Medical Director
W.vanBrakel@nlrinternational.org
P.O. Box 95005, 1090 HA Amsterdam, The Netherlands
www.nlrinternational.org | Twitter: @NLR_NoLeprosy
LML - S Deepak, B Naafs, S Noto and P Schreuder
LML blog link: http://leprosymailinglist.blogspot.it/
Contact: Dr Pieter Schreuder << editorlml@gmail.com
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