The United States: FDA updates on valsartan recalls

[Pages:2]The United States: FDA updates on valsartan recalls

The US Food and Drug Administration (FDA) continues to evaluate valsartan-containing products and has updated the list of products included in the recall and the list of products not included in the recall on 2 Aug 2018. The agency will continue to provide information when it becomes available.

FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of N-nitrosodimethylamine (NDMA) formation. The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities. If a manufacturer detects new or higher levels of impurity, they should take action to prevent changes to the product's safety profile.

Please refer to the following website in FDA for details:

In Hong Kong, there are 84 registered pharmaceutical products containing valsartan, and all products are prescription-only medicines.

A public announcement was issued on 6 Jul 2018 on the issue, and letters to inform local healthcare professionals of the latest development, including the affected products and recommendations on drug use, were issued by the Department of Health (DH) on 6 Jul 2018, 9 Jul 2018 and 25 Jul 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 6 Aug 2018. In light of the preliminary assessment made by the European Medicines Agency (EMA), letters to inform local healthcare professionals on the latest development of possible risk were also issued on 3 Aug 2018.

The DH contacted all certificate holders of registered valsartan products, among which Actavis Hong Kong Limited (Actavis) and Hong Kong Medical Supplies Ltd (HK Medical) confirmed that affected products have been marketed in Hong Kong.

The affected products are:Product

Valtensin 160mg tablets Valtensin 80mg tablets Valtensin HCT tablets 160/12.5mg Valtensin HCT tablets 80/12.5mg Valsartan Stada 80mg tablets

Hong Kong Registration Number HK-61786 HK-61787 HK-61784 HK-61785 HK-60794

Registration certificate holder Actavis Actavis Actavis Actavis HK Medical

According to Actavis and HK Medical, the above products have been supplied to local doctors and pharmacies. The products Valtensin 80mg and 160mg tablets have also been supplied to the

Hospital Authority. DH instructed Actavis and HK Medical to recall all the above five products from the market as a precautionary measure on 6 Jul 2018, and DH noted that the recall is completed.

Regarding announcements in Taiwan on NDMA contamination in valsartan API produced by Zhuhai Rundu and Zhejiang Tianyu (some batches), the DH contacted again all certificate holders of 84 registered valsartan products from 15 companies to follow up on the local impact. The reply from all certificate holders confirms that valsartan products available in local market are not manufactured using API produced by Zhuhai Rundu. On the other hand, Retoni Tablets 80mg (HK-65604) is a pharmaceutical product registered by Swiss Pharmaceutical Co Limited (Swiss Pharmaceutical). As confirmed with Swiss Pharmaceutical, the product is manufactured using API produced by Zhejiang Tianyu, the API was tested by the Taiwan Food and Drug Administration (TFDA) and the company has not received any information from the TFDA for NDMA contamination. All the other certificate holders confirm that their valsartan products available in local market are not manufactured using API produced by Zhejiang Tianyu.

So far, the DH has not received any adverse reactions related to the above products affected by the recall.

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, Aug 8, 2018 Issued at HKT 16:00

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