Analysis of NDMA levels in recalled valsartan in the U.S.

FDA on Friday 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." The agency announced on July 13 a recall of particular batches of valsartan tablets due to an impurity, the chemical N-nitrosodimethylamine (NDMA).

FDA on Friday 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." The agency announced on July 13 a recall of particular batches of valsartan tablets due to an impurity, the chemical N-nitrosodimethylamine (NDMA). According to records from the manufacturer of the recalled products, FDA said that "some levels of the impurity may have been in the valsartan-containing products for as long as 4 years. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full 4 years, there may be one additional case of cancer over the lifetimes of these 8,000 people." FDA decided to have these batches recalled based on that assessment. The agency also noted, "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 are not affected by the recall, or doctors may prescribe a different medication that treats the same indications." FDA also reported that several more companies that repackage drug products are recalling products that contain valsartan. The agency has product recall data from three more repackagers of valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals: labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack.