Health Canada expands efforts on nitrosamine impurities
- PDF / 151,219 Bytes
- 1 Pages / 595.245 x 841.846 pts (A4) Page_size
- 41 Downloads / 235 Views
1
Health Canada expands efforts on nitrosamine impurities Health Canada has announced that it has expanded its efforts to reduce the risk of potential carcinogenic Nnitrosodimethylamine (NDMA) and other nitrosamine impurities in sartan antihypertensives and ranitidine products. Health Canada has shared information with Canadian drug companies on the root causes of the impurities which have been identified, and requested companies to assess the possible presence of nitrosamines in their products and manufacturing processes; take measures to ensure that their products do not contain nitrosamines levels above the accepted limit; test products if a risk of nitrosamines is identified; and report to Health Canada if nitrosamines are detected. Health Canada has also conducted its own testing of sartan and ranitidine products, and developed validated laboratory test methods for use by pharmaceutical companies and other regulators. It has been working in collaboration with agencies in other countries including the US FDA and the European Medicines Agency. FDA testing has detected NDMA in nizatidine (Axid), and the Pendopharm Division of Pharmascience has now voluntarily stopped sale of this drug in Canada while it is being investigated by Health Canada. Health Canada will take action if a risk to Canadians is identified, and will inform the public of any new safety information on nitrosamine impurities. Health Canada. Health Canada updates Canadians on its ongoing assessment of nitrosamine impurities in certain drugs. Internet Document : 2 Dec 2019. Available from: URL: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc803439492 sc/2019/71770a-eng.php
0114-9954/19/1783-0001/$14.95 Adis © 2019 Springer Nature Switzerland AG. All rights reserved
Reactions 14 Dec 2019 No. 1783
Data Loading...
