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Regulatory Focus™ > News Articles > 2019 > 12 > Metformin: Regulators Respond After Singapore HSA Recalls Drugs for NDMA Impurities

Metformin: Regulators Respond After Singapore HSA Recalls Drugs for NDMA Impurities

Posted 06 December 2019 | By Michael Mezher 

Metformin: Regulators Respond After Singapore HSA Recalls Drugs for NDMA Impurities

Regulators including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) are looking into whether formulations of the diabetes drug metformin contain N-nitrosodimethylamine (NDMA) impurities.
The announcements come after Singapore’s Health Sciences Authority (HSA) on Wednesday recalled three out of 46 locally marketed metformin medicines after determining they contained NDMA “above the internationally acceptable level.” The three drugs were marketed by Singapore-based Glorious Dexa Singapore and Pharmazen Medicals Pte Ltd.
According to HSA, the risk posed by three medicines is low as they “have only been supplied locally for a short period of time since last year.”
The recall follows the discovery of nitrosamine impurities in angiotensin II receptor blocker (ARB) drugs in 2018 and in the heartburn drug ranitidine earlier this year.
In statements from FDA, EMA, Health Canada and MHRA on Thursday and Friday, the agencies said there is no evidence that any metformin medicines distributed in their respective jurisdictions are affected and advised patients to continue taking their medicine as prescribed.
In a statement, FDA’s Center for Drug Evaluation and Research Director Janet Woodcock said the agency “will work with companies to test samples of metformin sold in the US and will recommend recalls as appropriate if high levels of NDMA are found,” and noted that the levels of NDMA in metformin observed in other countries “are within the range that is naturally occurring in some foods and water.”
In its statement, EMA said that EU authorities are working with drugmakers to test medicines distributed in the EU. Meanwhile, Health Canada said it is asking drugmakers to “test their metformin products and is collecting samples from companies to conduct its own testing.”
FDA, EMA, Health Canada, MHRA

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