The FDA recalled drugs used for high blood pressure management and heart failure prevention due to an ingredient that could possibly lead to cancer.
These particular drugs contain the active ingredient valsartan, a generic drug used to treat high blood pressure. After looking into valsartan medications, it was discovered that valsartan may contain N-nitrosodimethylamine (NDMA), a possible human carcinogen. Three companies, Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd., were asked by the FDA to recall their valsartan products. Solco and Teva were also asked to recall their drugs containing valsartan/hydrochlorothiazide (HCTZ).
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “This is why we’ve asked these companies to take immediate action to protect patients.”
Now, the FDA is working on how to get rid of the impurities from future batches of these products, as well as investigating potential influences the medications have had on patients who have been using them. They advise any patients who are currently on these drugs to contact their physician about finding a suitable replacement and to continue the drug until then.
This isn’t the first case of valsartan either. Earlier in the year, the European Medicines Agency announced they were inspecting a drug with an active valsartan ingredient supplied Zhejiang Huahai Pharmaceuticals, a China-based company, for the very same reason. Three US-based pharmaceutical companies were supplied with these products from Zhejiang Huahai Pharmaceuticals.
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