The Therapeutic Goods Administration (TGA) announces that Sandoz Pty Ltd have initiated the recall of two irbesartan products due to the detection of N-Nitrosodiethylamine (NDEA) in the three IRBESARTAN/HCT SANDOZ batches JB0118, JC7036 and JC7037.
During testing of Irbesartan API (Active Pharmaceutical Ingredient) sourced from an external supplier traces of NDEA were found. An immediate internal assessment confirmed levels of this impurity above the Novartis internally established limits in line with the limits accepted by local Health Authorities in Europe (EMA).
Product Details are as follows :
1. IRBESARTAN/HCT SANDOZ 300/12.5
(irbesartan 300mg / hydrochlorothiazide 12.5mg film-coated tablets)
Batch No: JB0118
Expiry Date: May 2020
2. IRBESARTAN/HCT SANDOZ 300/25
(irbesartan 300mg / hydrochlorothiazide 25mg film-coated tablets)
Batch No: JC7036, JC7037
Expiry Date: June 2020
Please refer to the following website in TGA for details:
http://apps.tga.gov.au/../arn-detail.aspx?k=RC-2018-RN-01579-1
In Hong Kong, there are two products Irbesartan HCT Sandoz Tab 300mg/12.5mg (HK-61534) and Irbesartan HCT Sandoz Film-Coated Tablets 300mg/25mg (HK-61164) registered by Novartis Pharmaceuticals (HK) Limited (Novartis). As confirmed with Novartis, the two products HK-61534 and HK-61164 were not marketed in Hong Kong in past 3 years; the above three batches have not been imported into Hong Kong.
Currently in Hong Kong, there are 252 registered pharmaceutical products containing valsartan (83 products), candesartan (19 products), irbesartan (64 products), losartan (69 products) and olmesartan (17 products). All products are prescription-only medicines.
Regarding impurities in valsartan, a public announcement was 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 for the detection of impurities in sartan-containing products 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 12 Dec 2018.
In brief, there are four manufacturers, namely Zhejiang Huahai, Zhejiang Tianyu and Zhuhai Rundu in China and Hetero Labs Limited in India, reported to have detection of trace amounts of N-nitrosodimethylamine (NDMA) in the valsartan API by various overseas drug regulatory authorities. The DH contacted the certificate holders of all registered valsartan products to follow up on the local impact regarding valsartan API produced by the above mentioned manufacturers.
For API produced by Zhejiang Huahai, there are 5 affected products (HK-61786, HK-61787, HK-61784, HK-61785 and HK-60794) marketed in Hong Kong. The DH instructed the certificate holders to recall all the products from the market as a precautionary measure on 6 Jul 2018, and the DH noted that all the recalls have been completed.
For API produced by Zhejiang Tianyu, amongst the registered pharmaceutical products containing valsartan, there is only one product namely Retoni Tablets 80mg (HK-65604) registered by Swiss Pharmaceutical Co Limited (Swiss Pharmaceutical) which has used API produced by Zhejiang Tianyu and is available in the local market. As confirmed with Swiss Pharmaceutical, the API was tested by the Taiwan Food and Drug Administration (TFDA) and the company has not received any notice from the TFDA for NDMA contamination. The DH collected samples of Retoni tablets for analysis and no NDMA was detected.
For API produced by Zhuhai Rundu and Hetero Labs Limited, the certificate holders confirmed that the valsartan products available in local market are not manufactured using API produced by Zhuhai Rundu or Hetero Labs Limited.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of the second impurity of NDEA in the valsartan API produced by Zhejiang Huahai, there should be no local impact as all valsartan products manufactured using API produced by Zhejiang Huahai have been recalled from the market.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of NDEA in the valsartan API produced by Mylan Laboratories Limited in India, the certificate holders confirmed that the valsartan products available in local market are not manufactured using API produced by this company.
Regarding the European Medicines Agency’s (EMA) announcement on the detection of NDEA in the losartan API produced by Hetero Labs Limited, the US Food and Drug Administration’s (FDA) announcement on NDEA in the losartan API produced by Zhejiang Huahai, and the announcements issued by EMA, FDA and TFDA on NDEA in the irbesartan API produced by Aurobindo Pharma in India, the DH has contacted the certificate holders of all registered candesartan, irbesartan, losartan and olmesartan products and will continue to follow up on the impact of NDEA impurities on the products available in the local market.
So far, the DH has received 15 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 NDMA and/or NDEA. The DH will keep vigilant on any further updates on the matter issued by overseas regulatory authorities.
Patients who are taking the above products should not stop taking the medicines, but should seek advice from their healthcare professionals as soon as possible for proper arrangement.
Ends/Wednesday, December 19, 2018
Issued at HKT 18:30
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