The latest recall affects all lots of combination tablets that contain amlodipine and valsartan, as well as another combo drug featuring amlodipine, valsartan, and hydrochlorothiazide.
These products may contain an impurity known as N-nitroso-diethylamine (NDEA), which has been classified as a possible human carcinogen (cancer-causing substance), the U.S. Food & Drug Administration (FDA) said in a Recall Announcement issued on Tuesday.
FDA commissioner Scott Gottlieb said in a USA TODAY interview earlier this month that the blood pressure drug recalls reflect an increased focus on drug quality to ensure no impurities are present.
“We put out very big guidance on this – it’s a known risk,” Gottlieb said. “It’s a place where there’s been a significant increase in focus in recent years.”
FDA recommends that anyone taking these medications talk to their doctor about switching regimens, and to never stop taking a prescription drug without consulting their physician first. Doing so could have dire health consequences, the agency said.
Source: USA TODAY