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FDA Adds Context to Valsartan Recalls

Posted 27 July 2018 | By Zachary Brennan 

FDA Adds Context to Valsartan Recalls

The US Food and Drug Administration (FDA) on 13 July announced a recall of certain batches of valsartan tablets because of an impurity, a chemical known as N-nitrosodimethylamine (NDMA). The amounts of NDMA found in the recalled batches of valsartan exceeded acceptable levels.

On Friday, the agency said it “wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA.

“Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 people. This assessment led to FDA’s decision to have these batches recalled,” the agency said.

“Patients taking valsartan from a recalled batch should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. It is important to know that not all valsartan products contained NDMA, so pharmacists may be able to provide a refill of valsartan medication from batches that that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications,” FDA said.

FDA Update
 

Categories: Regulatory News

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