The European Union and national regulatory authorities continue their work to prevent the presence of nitrosamine impurities in medicinal products registered in the European Union.
Based on animal studies, nitrosamines are classified as probable human carcinogens. They are found in some foods and water and, when ingested at very low concentrations, are not expected to cause harm. In the few medicinal products in which nitrosamines have been detected, the risk to patients is expected to be low.
The CHMP review is currently examining the evidence on how N-nitrosodimethylamine (NDMA) appeared in some batches of ranitidine (https://www.ema.europa.eu/en/news/ema-review-ranitidine-medicines-following-detection-ndma).
In addition, the EMA and national authorities are assessing the impact of recent studies that detected NDMA in some batches of medicinal products containing metformin (used in diabetes). Further results of metformin testing in the European Union are expected. In line with previous recommendations, patients should continue taking metformin medicines as usual (https://www.ema.europa.eu/en/news/ema-update-metformin-diabetes-medicines). The risk of not adequately treating diabetes significantly outweighs the possible risks from the low nitrosamine content. Since metformin is considered a critical medicine, the European Medicines Agency and national authorities are working closely together to avoid a possible shortage of the medicinal product and so that patients can continue the necessary treatment.
The ongoing procedure (https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities#guidance-to-avoid-nitrosamines-in-human-medicines-section), aimed at providing guidance to companies on how to deal with nitrosamines in medicinal products, is currently gathering evidence and considering the views of leading EU experts. As a result of this procedure, which began in September 2019, measures to assess and reduce the risk of exposure to nitrosamines are being implemented throughout the EU.
EU authorities are also determining what lessons can be learned from the presence of nitrosamines in sartans, which became known in mid-2018 (https://www.google.com/search?q=ema+sartans&rlz=1C1GCEA_enNL873NL873&oq=EMA+s&aqs=chrome.0.69i59j69i57j69i59l2j0j69i60l3.1911j0j4&sourceid=chrome&ie=UTF-8). Recommendations on preventing and better managing the presence of impurities in the future are currently being finalized.
The EMA will continue close cooperation with national authorities, the EDQM1 and international partners and will take all necessary measures to protect the quality of medicinal products in the EU.
Link to the EMA press release
https://www.ema.europa.eu/en/news/update-nitrosamines-eu-medicines
https://www.ema.europa.eu/en/documents/press-release/update-nitrosamines-eu-medicines_en.pdf
