Health Canada announces an update on the status of ranitidine drugs in Canada, including enhanced safety measures the Department is putting in place to detect an impurity called N-nitrosodimethylamine (NDMA).
In Sep 2019, Health Canada directed companies to stop distributing ranitidine drugs in Canada as an interim, precautionary measure while it assessed the risk of NDMA detected in some drugs. Since then, companies have recalled products from the Canadian market because they contained or potentially contained NDMA above acceptable levels.
Health Canada has been evaluating the issue to identify potential causes and risk mitigation measures. Based on its evaluation, Health Canada permitted companies wishing to resume sales to do so provided they test every batch of ranitidine product before releasing it and regularly throughout its shelf life, to demonstrate that products do not contain higher than accepted levels of NDMA. Some companies resumed sales in Jan and Feb 2020.
While the root cause of NDMA in ranitidine remains unclear, Health Canada has since assessed additional information, including some evidence that suggests that levels of NDMA in ranitidine products may increase over time and when stored at higher than room temperature. In addition, some limited data suggest that NDMA may form in the body after ranitidine has been consumed, but this has not been confirmed.
As a result of its assessment of this additional information, Health Canada is now directing companies wishing to sell ranitidine products in Canada to undertake the following safety measures:
- continue to test every batch of ranitidine product before releasing it and test it regularly throughout its shelf life;
- conduct more frequent testing if NDMA is detected within a certain range below the accepted limit, to enable faster detection of any increases in NDMA;
- conduct additional testing to evaluate the potential for NDMA formation under different storage conditions (e.g., above room temperature); and
- provide all of the above test data to Health Canada, along with any information to help further evaluate the potential formation of NDMA from ranitidine in the body.
These strengthened measures will enable the Department to more actively monitor for NDMA in ranitidine products over their shelf life, and to take action as needed. They will also facilitate the collection of data to increase the understanding of NDMA formation.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../73607a-eng.php
Currently, there are 61 registered pharmaceutical products containing ranitidine in Hong Kong. These products in the forms of oral preparations and injections are controlled as over-the-counter medicines and prescription-only medicines respectively. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to ranitidine.
Related news on the detection of NDMA in ranitidine products was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 16 Sep 2019, with the latest update posted on 18 Jun 2020. Letters to inform local healthcare professionals were issued by the DH on 18 Sep 2019 and 2 Apr 2020. The DH has contacted the relevant overseas drug regulatory authorities for further information regarding the detection of NDMA in ranitidine products, and continues to remain vigilant on the update findings and investigation result announced by the authorities.
The DH has contacted the certificate holders of all registered ranitidine products for follow up on the local impact of the issue; and to provide evidence that NDMA in the products are below the acceptable limit, and samples of ranitidine-containing products have been collected from the market for analysis. When any health risks are posed to the public, a press statement will be issued as soon as possible. The following are the main content of the press statements issued previously:
- On 24 Sep 2019, the DH endorsed a licensed drug wholesaler, GlaxoSmithKline Ltd, to recall all Zantac products (HK-42792, HK-42793, HK-30459, HK-42045) from the Hong Kong market as a precautionary measure due to the presence of NDMA in the products.
- On 25 Sep 2019, the DH endorsed licensed drug wholesalers Hind Wing Co Ltd and Top Harvest Pharmaceuticals Co Ltd to recall Apo-Ranitidine Tablets (HK-42273, HK-41873) and Zantidon Tablets 150mg (HK-64329) respectively.
- On 27 Sep 2019, the DH endorsed licensed drug manufacturer APT Pharma Limited and licensed drug wholesaler Eugenpharm International Limited to recall Amratidine Tablets 150mg (HK-53143) and Peptil H 150 Tablets 150mg (HK-65103) respectively.
- On 30 Sep 2019, the DH endorsed licensed drug wholesaler Vast Resources Pharmaceutical Limited to recall Weidos Tablets 150mg (HK-62210).
- On 11 Oct 2019, the DH endorsed licensed drug wholesaler Hind Wing Co Ltd to recall Epadoren Solution for Injection 50mg/2ml (HK-61752).
- On 1 Nov 2019, the DH endorsed licensed drug wholesaler Welldone Pharmaceuticals Limited to recall 6 ranitidine-containing products: Epirant Tab 150mg (HK-56826), Welldone Ranitidine Tab 150mg (HK-57473), Kin Pak Tab 150mg (HK-56824), Wah Tat Tab 150mg (HK-56823), Super Pro Tab 150mg (HK-56825) and Glo-Tac Tab 150mg (HK-57472).
- On 7 Nov 2019, the DH endorsed licensed drug wholesalers Healthcare Pharmascience Limited, Julius Chen & Co (HK) Limited and Atlantic Pharmaceutical Limited to recall 5 ranitidine-containing products: Raniplex 150 Tablet 150mg (HK-43456), Tupast Tablet 150mg (HK-50378), Wontac Tablet 150mg (HK-60085), Jecefarma Ranitidine Tablet 150mg (HK-64041) and Ratic Tablet 150mg (HK-61083).
- On 12 Nov 2019, the DH endorsed registration certificate holder Medreich Far East Limited to recall Ulticer Tab 150mg (HK-53488).
- On 27 Nov 2019, the DH endorsed drug suppliers Cera Medical Limited and Sincerity (Asia) Company Limited to recall Emtac 150 Tab 150mg (HK-59353) and Ranitid 150 Tab 150mg (HK-59429) respectively.
On 16 Jun 2020, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided to keep vigilant on any safety update issued by overseas drug regulatory authorities for consideration of any action deemed necessary.
Patients who are taking ranitidine-containing products should seek advice from their healthcare professionals for proper arrangement, e.g. use of alternative medicines with similar uses.
Ends/Friday, Jul 24, 2020
Issued at HKT 17:00
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