EU Officials Recall Some Valsartan Medicines After Impurity Detected

Patrice Wendling


July 05, 2018

European authorities are recalling medications containing valsartan supplied by a Chinese drug maker because of concerns they may contain an impurity classified as a probable human carcinogen.

The European Medicines Agency (EMA) is reviewing valsartan-containing medicines after Zhejiang Huahai Pharmaceuticals detected N-nitrosodimethylamine (NDMA) in the active ingredient it supplies to manufacturers producing some valsartan medicines in the European Union, the agency reports in a July 5 news release.

NDMA is classified as a probable human carcinogen based on results from laboratory tests, it notes.

"The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured," the agency writes.

The EMA "will investigate the levels of NDMA in these valsartan medicines, its possible impact on patients who have been taking them, and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company," the letter said. "As a precaution, the review will also consider whether other valsartan medicines may be affected."

Further information will be provided once it is available from the review, to be carried out by the EMA's Committee for Medicinal Products for Human Use (CHMP).

In the meantime, national authorities in the European Union are recalling valsartan medicines containing the active substance supplied by Zhejiang Huahai, of Linhai, China.

Valsartan medications are used to treat high blood pressure as well as patients who have had heart failure or a recent heart attack.

Patients are advised not to stop taking their valsartan medication unless they have been advised to do so by their doctor or pharmacist, the letter notes.

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