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The FDA recalls a generic blood pressure medication because it was mixed with NDMA Quartz



The US Food and Drug Administration (FDA) is recalling some medications that are commonly used to control blood pressure because batches may contain a chemical that induces cancer cells in laboratory rats.

The recall was issued after a production change at China's Zhejiang Huahai Pharmaceutical Co. has inadvertently exposed an ingredient, valsartan, an organic chemical called N-nitrosodimethylamine (NDMA). This chemical is considered a likely carcinogen and may be toxic to the liver and other organs. The recall applies to three companies: Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

"We have carefully studied the valsartan-containing medicines sold in the US, and we have found that valsartan is sold by these specific products. Companies do not meet our safety standards," said Janet Woodcock, director of the FDA's drug evaluation center and research, in the agency's press release.

There are well-documented reasons to worry about the NDMA, not least about using it as a poison in a series of crimes. In 1

978, a German chemistry teacher was convicted in a case in which he tried to assassinate his wife by mixing NDMA into her blackberry jam. That same year, a man in Omaha, Nebraska, was sentenced to death for using NDMA to knock down the soda and kill a baby and a 24-year-old man at his girlfriend's family job. And in 2013, a Chinese student at Sudan University was poisoned by his roommate with NDMA, who had slipped into his chilled water. He died 15 days later.

This recall is particularly complicated because the use of medications with valsartan is so widespread. The FDA Drug Deficient Team is working to find ways to ensure that it continues to provide adequate care. The situation calls into question the safety and efficacy of medicines manufactured abroad for the US market and the security processes used by federal agencies. In an interview with the New York Times, cardiologist Harry Lever of the Cleveland Clinic said it would be harder for him to write prescriptions for patients because it is difficult to know exactly what is happening in some of India and China produced drugs.

In the US, Solco (pdf) said it "notifies its distributors and customers by letter and e-mail and arranges for the return of all recalled products."


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