The generic drug company Mylan Pharmaceuticals, has recalled three commonly prescribed blood pressure medications due to concerns that they could include small amounts of N-nitrosodiethylamine (or NDEA) a cancer-causing impurity. Each of the recalled drugs includes the blood-pressure medication valsartan, which has itself been the subject of a series of recalls by several drug companies since July of this year.
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(The recalled drugs are part of a class of drugs called” angiotensin II receptor blockers” which work by widening or relaxing blood vessels, thereby lowering blood pressure.)
“The generic drug company Mylan Pharmaceuticals recalled 104 lots of three medications: valsartan tablets, combination tablets with the drugs valsartan and amlodipine, and combination tablets with valsartan and hydrochlorothiazide. Amlodipine and hydrochlorothiazide in standalone form are not subject to the recall.”1
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The cause of the contamination was originally traced to a large factory in China and then a second factory in India but the FDA is still investigating. However, those factories have now been placed on “import alert” (drugs from those factories cannot be shipped into the US); “Factories that make drugs abroad are subject to inspection by the FDA”2 and are required to tell regulators about any changes they have made in the manufacturing of the drug ingredients.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said, “We still don’t understand the complete root cause of this problem. We understand part of it. We don’t understand all of the steps that led to this.”3 She went on to say that all ‘sartan’ medications were being tested to make sure they didn’t contain any of the impurities and that so far, no contaminants have been found in the brand name version of the drug, Novartis’ Diovan.
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If you are currently using one of the recalled drugs, alternatives are available. Just make sure you speak to your doctor first. If you have any questions about the recall, you can call 888-406-9305. To view a complete list of FDA updates on the recalls, click here.
Once the FDA completes its investigation, they will make their results public.
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