Health Canada is advising Canadians that Pro Doc Limitée is voluntarily recalling two lots of irbesartan tablets because of a nitrosamine impurity, N-nitrosodiethylamine (NDEA). The lots were distributed in Quebec only. The affected products are:
- IRBESARTAN (PRO DOC LIMITEE) 150 mg (lot: 604292; expiry: 10/2019)
- IRBESARTAN (PRO DOC LIMITEE) 300 mg (lot: 601795; expiry: 08/2019)
NDEA is classified as a probable human carcinogen, which means that long-term exposure could increase the potential risk of cancer. Pro Doc Limitée is conducting the recall after testing identified levels of NDEA above what is considered reasonably safe if the drug were taken over a lifetime.
The irbesartan active pharmaceutical ingredient (API) in the recalled lots is manufactured by Teva API India Ltd. An API is the active ingredient in a drug that produces an effect on the body. APIs are used in the manufacturing of finished dosage form drugs (such as pills, capsules or tablets).
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../69328a-eng.php
In Hong Kong, the above products of IRBESARTAN (PRO DOC LIMITEE) 150 mg and IRBESARTAN (PRO DOC LIMITEE) 300 mg are not registered pharmaceutical products.
Currently in Hong Kong, there are 248 registered pharmaceutical products containing valsartan (83 products), candesartan (19 products), irbesartan (62 products), losartan (67 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 11 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 will closely monitor the recall.
So far, the DH has received 16 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/Friday, Mar 15, 2019
Issued at HKT 16:00
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