The EU's drug regulator is reviewing certain high blood pressure and heart medicines containing an active substance supplied by Chinese company Zhejiang Huahai Pharmaceutical Co., Ltd.
The European Medicines Agency's review was triggered after Zhejiang Huahai detected an impurity known as N-nitrosodimethylamine, or NDMA — a substance that could cause cancer — in the valsartan active ingredient which it sells to some manufacturers producing medicines available in the EU.
"The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured" at the Chinese company's facility, the EMA said in a statement.
Medicines containing valsartan are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack.
Valsartan was developed by Novartis AG and sold under the name Diovan. Diovan, which now has generic competition, had been one of the best-selling drugs for the Swiss pharmaceutical giant.
While the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai.
The U.K.'s Medicines and Healthcare products Regulatory Agency advised pharmacies in the country to recall all batches of valsartan containing medicines made by Dexcel-Pharma Ltd, a unit of privately held Israeli company Dexcel PT Israel Ltd, and Accord Healthcare Ltd., a subsidiary of privately held Indian company Intas Pharmaceuticals Ltd.
The Danish Medicines Agency said that the sale of affected medicines is being stopped from the country's pharmacies. The regulator advised patients who had been treated with the affected valsartan-containing drugs to switch to an alternative as soon as possible.
The Danish regulator also brought out a list of medicines which are being recalled.
The EMA's Committee for Medicinal Products for Human Use will examine the levels of NDMA in the valsartan medicines, the impact of the NDMA on patients who have been taking them, and what can be done to reduce or eliminate the impurity from future batches produced by the company.
The committee will also review whether other valsartan medicines are affected.