The risk of cancer from N-nitrosodimethylamine (NDMA) contained in impure valsartan is real but very low, the Food and Drug Administration said in a July 27 statement.
The agency had announced a voluntary recall of valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals, as well as valsartan/hydrochlorothiazide from Solco and Teva, on July 13 after detection of NDMA, a semi-volatile organic compound. The manufacturer, Zhejiang Huahai Pharmaceuticals in Linhai, China, has since stopped distribution. Contamination probably is tied to a change in the manufacturing process.
NDMA has been linked to cancer in animal studies but at levels “much higher than the impurity levels in recalled valsartan batches.” Even so, the agency “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 FDA said in its updated press release.
Based on records from the manufacturer, “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,” the agency said.
“To put this in context, currently one out of every three people in the U.S. will experience cancer in their lifetime,” it said.
The FDA advised patients to check their prescriptions to see if they originate from one of the recalled batches, and to let their doctors and pharmacists know if they are.
To help, the FDA has posted a list of products included in the recall and a list of products not included in the recall.
They should also follow the recall instructions provided by the specific companies, the FDA said.