Valsartan Cancer Risk Explained by the FDA

The Food and Drug Administration (FDA) issued a press release on July 27, 2018, adding context around the potential risk posed to patients who used certain versions of valsartan.

On July 13th, the FDA announced a recall of drugs that contain valsartan, medications commonly used to treat high blood pressure and heart failure.

Zhejiang Huahai Pharmaceutical - a Chinese pharmaceutical company-  raised the alarm and voluntarily suspended its supplies in the international market after detecting an impurity, N-nitrosodimethylamine (NDMA) in the drug.

This FDA recall of certain batches of valsartan tablets is 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.

Based on previous animal studies, the U.S. Environmental Protection Agency considers NDMA a probable human carcinogen—a chemical that can increase the risk of cancer in humans.

It is estimated that over the course of a person’s lifetime, consuming 96 nanograms of NDMA would result in less than one additional case of cancer for every 100,000 people.

Which means this risk to humans is minimal.

To put this in context, currently, 1 out of every 3 people in the USA will experience cancer during their lifetime.

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 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 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.

According to the FDA, 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 continues to evaluate the safety of valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available.

The following additional repackagers are recalling or are expected to recall valsartan-containing products. FDA is working to gather product recall information from these companies and has removed them from the list of products that are not impacted by this recall:

• Bryant Ranch Prepack Inc.
• H. J. Harkins Company Inc. (this company was not originally included on either list)
• Lake Erie Medical, doing business as Quality Care Products LLC
• NuCare Pharmaceuticals Inc.
• Northwind Pharmaceuticals
• Proficient Rx

If you are taking a valsartan product, be sure to check back, as the lists may change.

Consumers and health care professionals should continue to report any adverse reactions with valsartan-containing products, to the FDA’s MedWatch program to help the agency better understand the scope of the problem.