The U.S. Food and Drug Administration is alerting healthcare professionals and patients of a recall of several drugs that contain the ingredient valsartan.
Valsartan is used to treat high blood pressure and heart failure, according to the FDA. There has been an impurity found in valsartan called N-nitrosodimethylamine (NDMA).
NDMA is classified as a probable human carcinogen based on lab tests.
The FDA believes this sudden presence of NDMA is because of the way the substance was manufactured.
Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product, according to the FDA.
Below is a list of the recalled products:
- Valsartan from Major Pharmaceuticals
- Valsartan from Solco Healthcare
- Valsartan from Teva Pharmaceuticals Industries Ltd.
- Valsartan/Hydrochlorothiazide (HCTZ) from Solco Healthcare
- Valsartan/Hydrochlorothiazide (HCTZ) from Teva Pharmaceuticals Industries Ltd.
Patients should contact their healthcare professional (the pharmacist who dispensed the medication or the doctor who prescribed the medication) if their medicine is included in the recall to discuss treatment.
It could include another valsartan product not affected by this recall or an alternative treatment option.
“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
