| HealthLine – Several high blood pressure drugs were recalled due to an “unexpected” impurity.
The U.S. Food and Drug Administration (FDA) has expanded a recall announced last month involving drugs containing valsartan, which is used to treat high blood pressure and heart failure.
The products were voluntarily recalled due to the presence of an impurity, N-nitrosodimethylamine (NDMA), a substance that poses a potential cancer risk.
NDMA is classified as a probable human carcinogen based on laboratory tests.
Late last week, FDA officials announced they had updated the list of drugs affected by the recall. They also noted the recall is now a worldwide recommendation.
The agency also released a list of drugs not affected by the recall.
Multiple companies are voluntarily recalling their medications, including valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd., as well as valsartan/hydrochlorothiazide from Solco and Teva.
The FDA said in a statement that “the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”
The affected drugs are all generic versions of brand name Diovan, which is made by Novartis International AG. Diovan and generic versions made by other companies are not included in the recall.
[Novartis has more than 25 major production sites worldwide including China, Indonesia, and Malaysia. It is unknown which plant(s) made the recalled products. – Editor]
“It’s not the drug valsartan that’s the problem. It’s a contaminant that was included in the manufacturing process that’s the problem. Patients shouldn’t lose faith in the drug itself,” said Dr. Victoria Shin, a cardiologist with Torrance Memorial Medical Center in Torrance, California.
She added that she doesn’t expect the recalls to affect patient care because of the availability of other valsartan products.