A number of recalled valsartan products could present the risk of cancer due to a contamination. Patients using these recalled valsartan products should consider speaking with their doctor right away about switching to a new medication.

The FDA recently added more recalled valsartan products to their list. The impacted medications are those with valsartan inside. This is a generic ingredient in medications given to people with a risk of heart failure and problems with high blood pressure.

The recalled valsartan products were pulled off the market because the ingredient was allegedly tainted with NDMA, a potential carcinogen. The most recently added recalled valsartan products were sold under the name RemedyRepack, but these are not the only medications affected by the recall.

NDMA is an impurity linked to cancer development. This chemical has been used to make liquid rocket fuel. Unfortunately, NDMA can be accidentally introduced to the manufacturing process through various chemical reactions.

While not every version of the medications containing valsartan are on the recalled valsartan products list, the FDA is currently keeping a list of the drugs impacted so that consumers know what to do.

NDMA Contamination

The FDA evaluated the valsartan products after it was discovered that an impurity might have been introduced during the manufacturing process. The FDA then tested for another impurity known as NDEA. The agency found that not all batches of the drugs were contaminated.

After issuing the initial list of recalled valsartan products, the FDA also put the company responsible for the impure batches, Zheijang Huahui Pharmaceuticals, on an import alert. As this occurred at the end of the September, nearly all finished products and active pharmaceutical items made by the company will not be allowed into the U.S. This decision came down after the FDA inspected the facility.

The FDA shared that the risk of cancer from contaminated valsartan is low. The possibility of one additional case of cancer emerging would be one in 8,000 individuals taking the highest dose of valsartan with NDMA over the course of a four year period.

However, the agency is still running tests to determine the true risk of developing cancer from taking the recalled valsartan products. The agency shared recently that they will continue to test all products that contain valsartan to determine whether or not the risk of impurities and carcinogens exist in other batches.

While the risk of developing cancer from the recalled valsartan products is low, it is still present. Anyone who is taking a drug they are concerned could be contaminated with impure valsartan should first speak to their doctor about next steps before discontinuing the drug to minimize potential issues with the underlying condition that led to the valsartan-containing drug being prescribed in the first place.