FDA recalls common heart drug over cancer concerns

Last week the FDA issued a voluntary recall of the drug Valsartan, commonly used to control blood pressure and prevent heart failure, over concerns about “the presence of an impurity, N-nitrosodimethylamine (NDMA).”¹

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The organic chemical, often used in rocket fuel, softeners, and lubricants, is a known cancer risk. In fact, studies on animals have shown NDMA to be toxic and cause tumors to the liver, kidney and respiratory tract. And according to the Department of Health and Human services, humans exposed to high levels of NDMA can experience liver damage that could result in cancer.

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The drug manufacturers affected include Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries, Ltd¹ with the recall also including a valsartan/hydrochlorothiazide (HCTZ) medication that’s sold by Solco Healthcare and Teva Pharmaceuticals Industries, Ltd.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said:

“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. This is why we’ve asked these companies to take immediate action to protect patients.”¹

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While the FDA’s investigation into the drugs is ongoing, I’m not sure I would need the FDA to tell me to stop taking it immediately. However, doctors never recommend people stop taking their heart medications without their physician’s supervision and since I am not a doctor I’ll suggest you speak to them: Please, if you are on a heart-monitoring medication, speak to your doctor as soon as you are able to make sure your prescriptions aren’t affected by the recall.