Health Canada is advising Canadians that Auro Pharma Inc. is voluntarily recalling one lot of Auro-Irbesartan/hydrochlorothiazide (HCT) combination tablets 150 mg/12.5 mg (Lot: IN1518001-A; Expiry: April 6, 2020) because of a nitrosamine impurity, N-nitrosodiethylamine (NDEA). The affected lot was released in Aug 2018 and distributed only in Ontario and Quebec.
NDEA is classified as a probable human carcinogen, which means that long-term exposure could increase the potential risk of cancer. Auro Pharma Inc. is conducting the recall after Health Canada’s testing identified levels of NDEA above what is considered reasonably safe if the drug were taken over a lifetime.
There have been multiple recalls of products containing other sartans in Canada and internationally since Jul 2018 because of nitrosamine impurities. Health Canada continues to work with companies and international regulatory partners, including the US Food and Drug Administration and the European Medicines Agency, to assess the issue of nitrosamine impurities in certain sartan drugs, its root causes and mitigation measures.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../69668a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product.
Currently in Hong Kong, there are 246 registered pharmaceutical products containing valsartan (83 products), candesartan (19 products), irbesartan (62 products), losartan (65 products) and olmesartan (17 products). All products are prescription-only medicines.
Regarding impurities in sartan-containing products, a public announcement was first issued on 6 Jul 2018, and letters to inform local healthcare professionals were issued by the Department of Health (DH) on 6 Jul 2018, 9 Jul 2018, 25 Jul 2018 and 3 Aug 2018. Related news was also previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 6 Jul 2018, with the latest update posted on 29 Mar 2019.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in sartan-containing products, the following 5 valsartan products and 1 irbesartan product were affected and recalled from the Hong Kong market on 6 Jul 2018 and 20 Dec 2018 respectively: HK-61786, HK-61787, HK-61784, HK-61785, HK-60794 and HK-63378. The DH noted that these recalls were completed.
The DH had collected samples of sartan-containing products in the local market for analysis. No NDMA and NDEA were detected.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of N-nitroso-N-methyl-4-aminobutyric acid (NMBA) in losartan, the DH endorsed the recall of 4 losartan products (HK-61932, HK-61933, HK-62634 and HK-62635) from the local market as a precautionary measure due to the potential for NMBA in the products on 11 Mar 2019. The DH noted that the recall was completed.
So far, the DH has received 17 cases of adverse drug reaction related to valsartan, candesartan, irbesartan, losartan and olmesartan. None of them is concluded to be related to the presence of impurities such as NDMA, NDEA and/or NMBA. The DH will keep vigilant on any safety updates on detection of impurities in sartan-containing products issued by overseas regulatory authorities.
Patients who are taking sartan-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals as soon as possible for proper arrangement.
Ends/Tuesday, Apr 23, 2019
Issued at HKT 16:00
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