The FDA recalls a common blood pressure drug because it was mixed with NDMA – Quartz

The US Food and Drug Administration recalls some commonly used drugs to help control blood pressure, as some of these drugs may contain a chemical used to induce cancer in laboratory rats

. The manufacturing change at Zhejiang Huahai Pharmaceutical Co. of China inadvertently exposed an ingredient, valsartan, to an organic chemical called N-nitrosodimethylamine (NDMA). This chemical is considered a probable 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. The agency is asking these companies to remove their Valsartan drugs from the market, which include tablets bearing the "Valsartan" brand, but also branded tablets such as Actavis, according to the FDA website.

"We carefully evaluated drugs containing valsartan sold in the United States, and found that valsartan sold by these companies did not meet our safety standards," said FDA's Janet Woodcock, director of the Center. for evaluation and research on drugs in the press release of the agency

There are well-documented reasons to worry about NDMA, especially its use as a poison in a number of crimes. . In 1978, a German chemistry professor was convicted in a case (in German) in which he attempted to murder his wife by mixing NDMA in his blackberry jam. The same year, a man from Omaha, Nebraska, was sentenced to death for using NDMA to blow up lemonade and kill a baby and a 24-year-old man in his girlfriend's family. And in 2013, a Chinese student from the University of Sudan was poisoned by his roommate with NDMA who had been slipped into his icy water. He died 15 days later.

This recall is particularly complicated because the use of drugs with valsartan is so prevalent. The FDA drug shortage team is working to find ways to ensure an adequate supply. The situation calls into question the safety and effectiveness of drugs manufactured abroad for the US market and the security processes used by federal agencies. In an interview with The New York Times, Cleveland's cardiologist, Harry Lever, said that it was becoming increasingly difficult to write prescriptions for patients because it's hard to know what's going on in some countries like India and China.

In the United States, Solco stated (pdf) that it "notifies its distributors and customers by letter and email and that it organizes the return of all recalled products."