Canada, The EU, and India Join the FDA’s Valsartan Medicine Recall

As previously announced, a review of valsartan medicines in relation to an impurity found in the valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals is ongoing, confirmed the European Medicines Agency (EMA).

According to the EMA, the impurity – N-nitrosodimethylamine (NDMA) – is classified as a probable human carcinogen which, based on results from laboratory tests, may cause cancer with long-term use.

Since July 17, 2018, national medicines authorities across the EU have been recalling medicines containing valsartan produced from China’s Zhejiang Huahai, said the EMA in a press release.

This review was triggered by the European Commission via Article 31 of Directive 2001/83/EC and is being carried out by the Committee for Medicinal Products for Human Use, responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion.

The EMA said healthcare professionals should follow specific advice from national authorities concerning medicines in their respective country.

Moreover, these medicines should no longer be available in pharmacies in the EU.

In Canada, Sandoz Canada recalled batches of Sandoz Valsartan film-coated tablets at the pharmacist and wholesaler levels.

But, this recall does not affect Sandoz Valsartan HCT in Canada or any Novartis Pharmaceuticals products containing valsartan, namely Diovan®, Diovan/HCT® and Entresto®.

Additionally, on July 20, 2018, India’s drug controller has initiated an investigation into medicines from Zhejiang Huahai.

To clarify this recall in the USA, the Food and Drug Administration issued a press release on July 27, 2018, adding context around the potential risk posed to patients who used certain versions of valsartan.

Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other active substances.

Separately, a fact sheet developed by the U.S. Environmental Protection Agency provides a summary of the contaminant N-Nitrosodimethylamine, including physical and chemical properties; environmental and health impacts; existing federal and state guidelines; detection and treatment methods; and additional sources of information.