The Health Sciences Authority (HSA) is recalling three brands of blood pressure medicines, which contain a losartan ingredient that was manufactured by Hetero Labs Limited. These products were found to contain trace amounts of a nitrosamine impurity, N-nitroso-N-methyl-4-aminobutyric acid (NMBA), which are above internationally acceptable levels. The affected products are:
- Hyperten Tablet: Losartan Potassium 50mg and 100mg; local supplier: Goldplus Universal Pte Ltd
- Losagen Tablet: Losartan Potassium 50mg and 100mg; local supplier: Medicell Pharmaceutical (S) Pte Ltd
- Losartas Tablet: Losartan Potassium 50mg and 100mg; local supplier: Apotheca Marketing Pte Ltd
Patients are advised not to stop treatment on their own as there is no immediate health risk associated with taking the affected medicines. The HSA has advised healthcare professionals to review the medicine and treatment plans of their patients. Not all losartan medicines are affected by this recall. Only three out of the ten losartan products in Singapore contain unacceptable levels of nitrosamine impurity.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../losartanrecallhetero.html
In Hong Kong, the above products Hyperten Tablet, Losagen Tablet and Losartas Tablet 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 23 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 29, 2019
Issued at HKT 16:00
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