The U.S. Food and Drug Administration is alerting health care 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.
Here are some of the companies who are recalling products:
- Major Pharmeceuticals: Valsartan
- Solco Healthcare: Valsartan and Valsartan/Hydrochlorothiazide (HCTZ)
- Teva Pharmaceuticals Industries Ltd.: Valsartan and Valsartan/Hydrochlorothiazide (HCTZ)
Patients who are taking one of the recalled medicines listed above should follow the recall instructions that are provided by the FDA's website.
An important note to add for patients who are taking valsartan is that this medication is used to treat various other serious medical conditions and if a patient is taking the recalled medication, they should continue to take it until a replacement product is made available.
Also, you should contact your doctor of whoever the pharmacists was that dispensed the impacted drugs to you to discuss an alternative 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.
The FDA is continuing to investigate the issue and will add more information as it becomes available.