Chinese Drugmaker Recalls Cancer-Causing Medicines in US

Faith Castro
July 20, 2018

Through recent communication with FDA, Major Pharmaceuticals learned of a potential issue with the active pharmaceutical ingredient in Valsartan supplied by Teva Pharmaceuticals which may contain the probable carcinogen N- nitrosodimethylamine (NDMA).

The FDA points out that not all products containing valsartan are being recalled. The department added that it is in continuous contact with World Health Organization, institutions and other health organization for medicines and pharmaceuticals.

The recalled medications include Valsartan Tablets manufactured by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals, as well as Valsartan/Hydrochlorothiazide Tablets from Solco Healthcare and Teva Pharmaceuticals.

All of the valsartan that is being recalled was made in China by the same company, Zhejiang Huahai Pharmaceutical Co. Ltd.

The impurity NDMA is a substance that occurs naturally in foods, drinking water, air pollution, and industrial processes, according to the US Food and Drug Administration (FDA). Environmental Protection Agency, humans exposed to NDMA for an extended period of time may develop liver damage, which can lead to cancer.

TEVA is notifying its Direct Accounts by FedEx Overnight mailing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts of this product recall and making arrangements for impacted product to be returned to Inmar.

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However, not all products containing valsartan are being recalled.

Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.

The Provincial Pharmacovigilance Centre Punjab issued an alert asking manufacturers to review their sources of raw materials of valsartan (a formula used in the making of hypertension medicines). The Valsartan products on the Barbados market are produced by Novartis and Jubilant and are not subject to the worldwide recall.

"The FDA is committed to maintaining our gold standard for safety and efficacy", said FDA Commissioner Scott Gottlieb, M.D. In the meantime, the Agency plans to continue its investigation into the possible effects NDMA might have on patients who have been taking these products. "It's becoming very hard for me to write prescriptions at all".

The FDA believes this sudden presence of NDMA is because of the way the substance was manufactured.

Overall, more than two-thirds of all active drug ingredients originate in China and India, industry experts estimate, with China accounting for the lion's share.

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