NEW HAVEN, Conn. — Valisure, a New Haven, Connecticut online pharmacy who distributes the high blood pressure medication valsartan, alerted the U.S. Food and Drug Administration to the presence of a known carcinogenic substance in its medication according to an article appearing in the Bloomberg.com. Valisure tested six samples of valsartan, including a sample from Novartis AG, a large Swiss drug manufacturer, and found the solvent dimethylformamide, or DMF for short. The World Health Organization concluded that DMF was a carcinogen in 2018. Notwithstanding, the U.S. Food and Drug Administration (FDA) allows ingestion of a minuscule amount of DMF every day.
The detection of the solvent DMF in medication taken by millions of people daily is a scary thought. Valsartan is an alternative to losartan which health officials recalled because of the presence of another carcinogen in it known as NDMA. But, companies like Novartis AG, in particular, say that they do not use DMF as a solvent in the medical manufacturing process. However, a Novartis AG spokesperson said that the company could not say that any of the companies in its supply chain does not use the solvent.
The FDA is experiencing significant difficulty offering safe alternatives to these high blood pressure medications that contain carcinogens. Given the state of the drug manufacturing industry, it is no small wonder. An executive from Valisure said that the medicine a person takes daily was probably made several years before and drug makers who produce generic drugs use solvents to create the drugs more quickly, including solvents like DMF. DMF should deteriorate before a patient ingests the pill, but often it does not. Additionally, regulators examine active ingredients much more closely than inactive ingredients in medicines. Thus, carcinogens could be included in a pill because it is a component of an inert substance.
The losartan line of drugs is under heavy watch after a Chinese manufacturer, and an Indian manufacturer of losartan recalled the drug because of a carcinogen found in an active ingredient. Those companies now face a class-action lawsuit filed by 34 plaintiffs claiming those drug makers deceived them.
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