ARB Impurities Less Dangerous Than FDA First Believed, Woodcock Says

CDER Director Janet Woodcock said that the FDA believes the risks posed to patients by nitrosomine impurities in blood pressure drugs are “likely much lower” than initially thought.

The agency initially predicted that if 8,000 people took the highest valsartan dose (320mg) contaminated with n-nitrosodimethylamine (NDMA) from recalled batches every day for four years, there “may be one additional case of cancer over the lifetimes” of those people.

But “in reality, the vast majority of patients exposed … received much smaller amounts of the impurity than this worst-case scenario, and since not all angiotensin II receptor blockers (ARBs) are affected, it’s very likely that a patient taking an ARB for four years would not have always received one of the affected products,” she said.