The U.S. Food and Drug Administration has expanded the list of drugs under recall due to a chemical impurity that could put patients at risk of getting cancer.
Officials announced the voluntary recall last month of some drugs containing valsartan, a medication used to treat heart failure and blood pressure that’s often a component of generic medicines. Last week, the recall was expanded to include drugs under 10 brand names or manufacturers.
The drugs are being recalled because they contain a chemical known as N-nitrosodimethylamine (NDMA), a possible carcinogen, according to the FDA. Officials said animal studies have shown an increased risk of cancer associated with NDMA, however, “These animal studies were done using amounts of NDMA much higher than the impurity levels in recalled valsartan batches.”
Officials noted that some water supplies and foods contain NDMA.
Still, according to the FDA, “The amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels.”
Valsartan was previously recalled in 22 other countries, according to CNN. The current recall is centered around valsartan manufactured in Linhai, China, FDA officials said.
Authorities believe the impurities were caused by a change in the way the drug was manufactured. Officials said in an update last week that the FDA is working with drug manufacturers “to ensure future valsartan active pharmaceutical ingredients are not at risk of NDMA formation.”
Authorities continue to investigate.
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