TGA finds low levels of NDMA contamination in metformin products
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TGA finds low levels of NDMA contamination in metformin products Approximately 30% of a selection of immediate-release and extended-release metformin products has been shown to contain higher-than-normal levels of NDMA, says the TGA.* In late 2019, the Australian regulatory agency began investigating the potential contamination of metformin products for the presence of NDMA (i.e. a probable human carcinogen). After recent completion of testing on a selection of metformin products, the TGA noted that "approximately 30% of batches contained levels of NDMA that modestly exceed the acceptable limit (less than twice the limit)". In addition, one batch was found to have >4-times the acceptable limit, but only limited stock of this batch was supplied and has now been recalled from wholesalers. The TGA carefully considered the risks for patients who received metformin batches that modestly exceeded the NDMA limits, and noted that "the majority of patients would not be exposed to levels of NDMA that exceed the acceptable intake limit". Overall, the agency acknowledged that the NDMA limits set by the TGA "are very conservative" and "are calculated to ensure that an individuals’ excess cancer risk would not exceed 1:100,000 if that individual was on the maximum daily dose of the medicine for 70 years". The TGA concluded that given that most individuals do not take the maximum daily dose of metformin, or use the drug for 70 years, then "the risks are very low". The agency is continuing to work with the sponsors of metformin medicines to ensure that this critical diabetes treatment remains available, and that consumers are no exposed to unacceptable NDMA levels. Furthermore, the TGA said that it is working with drug manufacturers "to oversee the implementation of improved manufacturing and testing processes that will ensure that metformin medicines supplied in Australia meeting our high standards for quality". * NDMA = N-nitrosodimethyamine; TGA = Therapeutic Goods Administration Therapeutic Goods Administration. Metformin: Low levels of contamination with N-nitrosodimethylamine (NDMA). Internet Document : 18 Nov 2020. Available from: URL: 803520358 https://www.tga.gov.au/alert/metformin-0
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Reactions 5 Dec 2020 No. 1833
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