FDA warns maker of ingredient in huge heart drug recall

After an expanded recall of the blood pressure medication valsartan and other drugs, FDA is warning the manufacturer of the carcinogenic ingredient involved.

Last week, Mylan Pharmaceuticals expanded its voluntary nationwide recall to include all lots of valsartan-containing products distributed in the United States between March 2017, and November 2018, at the consumer level.

“Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA), contained in the API valsartan, USP, manufactured by Mylan Laboratories Limited,” Mylan said in a statement. “NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).”

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Now, FDA is issuing a warning letter to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang, China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines, FDA said in a statement.

The letter outlines several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control, and cross contamination from one manufacturing process line to another. However, the agency is still looking into the root cause of the impurity.

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“We’re continuing to investigate and take action to protect patient health and safety from products in this angiotensin II receptor blocker class that have been found to have dangerous impurities. As part of that investigation, we’ve uncovered serious manufacturing violations at ZHP.…these violations reveal a disturbing lack of oversight at this API manufacturer that puts patients at risk,” said FDA Commissioner Scott Gottlieb, MD, in a statement from the agency.

FDA announced recalls of valsartan beginning in July due to the presence of N-Nitrosodimethylamine (NDMA) in API supplied by ZHP. Subsequent international investigations expanded to include all manufacturers of API and finished drugs in the ARB class and have resulted in additional recalls of valsartan, irbesartan, and losartan-containing products found to contain NDMA and N-Nitrosodiethylamine (NDEA) – both known animal and suspected human carcinogens.  

FDA is continuing to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities.

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