FDA expands probe into common heart drugs linked to cancer: 5 things to know

The FDA is expanding its investigation into valsartan heart drugs, which are used to control blood pressure and prevent heart failure, after discovering an ingredient used in the products is  a probable human carcinogen.

Here are five things to know:

1. The heart drugs, which are angiotensin II receptor blockers, were found to contain an impurity known as n-nitrosodimethylamine, a chemical once used to make rocket fuel and an unintended byproduct of several chemical reactions.

2. On July 13, seven days after 22 other countries issued a recall of the product, the FDA recalled several products made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals that contained valsartan. The three pharma companies used valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, based in Linhai, China.

3. Since the discovery of the carcinogenic impurity, several other drugmakers recalled their products containing valsartan.

4. The probe aims to "identify the root cause of this impurity …  prevent a recurrence of this episode and protect patients who need this medication," the FDA's statement reads. The impurity may have resulted from changes Zhejiang Huahai made to its manufacturing process of valsartan but the FDA is "still not 100 percent sure that this is the root cause of the problem."

5. The FDA is testing all products in the angiotensin II receptor class to determine if they also have traces of n-nitrosodimethylamine.

"These tests will continue until we identify all products that may contain NDMA in the ARB class, and they are no longer available in the U.S.," the FDA said.

Read the full press release here.

 

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