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Over the past few months, numerous recalls of the popular heart drug valsartan have already occurred. Now, generics maker Mylan Pharmaceuticals is adding more products to the list. The recall involves 104 lots of three medicines: valsartan tablets; combination tablets with the drugs valsartan and amlodipine; and combination tablets with valsartan and hydrochlorothiazide.
The reason for the move is similar to that cited in prior valsartan recalls: Mylan said it had detected trace amounts of a probable cancer-causing chemical called N-nitrosodiethylamine (NDEA) in valsartan meds. NDEA is found in certain foods, drinking water, air pollution and industrial processes.
The U.S. Food and Drug Administration is currently trying to trace the source of the contaminants, originally linked to factories in China and India that help supply valsartan to generic drug makers. Those factories were linked to contamination with a second type of potential carcinogen, called N-nitrosodimethylamine, or NDMA.
Valsartan is used to treat high blood pressure, heart failure, and to reduce the risk of death after a heart attack. Valsartan in combination with amlodipine or hydrochlorothiazide is used to treat high blood pressure.
The expanded recall includes: 26 lots of amlodipine and valsartan tablets, USP (5 mg/160 mg; 10 mg/160 mg; 5 mg/320 mg; and 10 mg/320 mg); 51 lots of valsartan tablets, USP (40 mg, 80 mg, 160 mg and 320 mg); and 27 lots of valsartan and hydrochlorothiazide tablets, USP (80 mg/12.5 mg; 160 mg/12.5 mg; 160 mg/25 mg; 320 mg/12.5 mg; and 320 mg/25 mg).
The drugs were distributed in the United States between March 2017 and November 2018.
Speaking with USA Today, the FDA’s Janet Woodcock said that “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.”
Woodcock directs the agency’s Center for Drug Evaluation and Research. She said the factories implicated in the recall have been placed on “import alert,” meaning that drugs manufactured by these plants cannot enter the United States.
In addition, all “sartan” medicines are being tested to be sure they don’t contain the contaminants, Woodcock said. So far, the carcinogens have not turned up in Diovan, the brand-name version of valsartan made by Novartis, she noted.
“I would think these recalls would start dropping off now,” Woodcock told USA Today. “We’ve had this import alert in place for quite a long time, and the companies buying from these sources were told to check and recall.”
In the meantime, Mylan said that patients who are taking valsartan should continue to do so, because the risk to their health may be higher if they stop taking it immediately without any alternative treatment.
Instead, patients should talk to their pharmacist or physician about an alternative treatment, and should contact their healthcare provider if they’ve experienced any problems that may be related to the recalled valsartan products, the company advised.