Recall of drugs containing the active ingredient valsartan from the Chinese manufacturer Zhejiang Huahai Pharmaceutical

A batch-related recall of medicines containing valsartan, the active ingredient of which was produced by the Chinese manufacturer Zhejiang Huahai Pharmaceutical, is currently taking place in the European Union. The affected drugs are used to treat hypertension.

The reason for the recall is a possible production-related contamination of the active ingredient with N-nitrosodimethylamine. This substance is classified by the WHO's International Agency for Research on Cancer and the EU as a probable human carcinogen. So far, no information is available on whether and in what concentrations the impurity is contained in these medicines. The recall of all affected batches is therefore being carried out throughout Europe as a precautionary measure until the facts of the matter have been clarified.

An initial scientific assessment of the hazard potential has already been carried out at European level and an acute hazard can be ruled out at the present time. However, since such contamination cannot be tolerated on the basis of the precautionary principle, a recall of all potentially affected medicines will be carried out. Further investigations are underway throughout Europe and are being coordinated by the European Medicines Agency (EMA) and agreed jointly with the member states. The aim of the procedure is to take harmonized measures throughout Europe to protect patients.

Patients taking medicines containing valsartan should not discontinue the medicines under any circumstances without consulting their doctor, as the health risk of discontinuation is many times higher than the potential risk from contamination. There is no acute patient risk.

Situation in Austria

In Austria, the following marketed drugs are affected: (as of Aug. 14, 2018).

Information on the affected lot numbers can be found in the BASG safety letters regarding the recalls.

The BASG has not received any adverse event reports from Austria for the above-mentioned drugs that are relevant to this issue.

Recommendations of the BASG

Recommendations for patients:

If you have further questions or feel unsure, please contact your physician or pharmacist.

Further Information

Official recall letters link on BASG website:

https://www.basg.gv.at/news-center/news/news-detail/article/valsartan-1250/

European Medicines Agency (EMA) Press Release:

EMA press release of 05/07/2018.

EMA press release of 17/07/2018.

Queries

Queries (technical):

Dr. Christoph Baumgärtel, Tel: +43 505 55-36004 Email: christoph.baumgaertel@ages.at

Queries (for media):

Communications Management, Tel.: +43 505 55-25000 E-mail: presse-basg@basg.gv.at

Further inquiry note

basg_anfragen@basg.gv.at