Valsartan is a blood pressure medication that has, in recent months, been the subject of a number of recalls due to valsartan cancer risk from a serious impurity.

Valsartan is manufactured by Chinese company Zhejiang Huahai Pharmaceutical, and when a potentially cancer-causing substance was found in the company’s valsartan drugs, the U.S. Food and Drug Administration (FDA) halted imports from the company. The FDA is now investigating how the impurity, potential carcinogen N-nitrosodimethylamine (NDMA), made its way into valsartan drugs.

Basics of Valsartan

Valsartan blood pressure medication, the generic equivalent to the brand drug Diovan, belongs to a group of hypertension medications called angiotensin II receptor agonists. Manufactured by Zhejiang Huahai, valsartan is distributed in the U.S. by several companies, including Teva Pharmaceuticals, Major Pharmaceuticals, Solco Healthcare, and more. The FDA approved valsartan to treat high blood pressure in adults, as well as children age six and older. For adults, this drug has also been approved to treat heart failure. For patients who are recovering from a heart attack, valsartan has also been approved to reduce this risk.

Under the FDA’s import alert, active pharmaceutical ingredients as well as finished drugs made by Zhejiang Huahai cannot legally enter the United States. The FDA said that it believes this impurity may have existed at some level in valsartan products for up to the last four years.

The halt on these imports is not the first move made to combat the potential valsartan cancer risk caused by such impurities. A number of valsartan-containing drugs have already been recalled voluntarily due to the impurity revealed by testing.

The Valsartan Recall

Despite the widespread use of valsartan, this popular blood pressure medication is also reportedly capable of causing a number of serious complications, including liver damage and even cancer.

Indeed, N-nitrosodimethylamine, the impurity found in certain valsartan drugs, is an environmental contaminant considered a probable human carcinogen by the FDA—that is, a substance likely capable of increasing the risk of cancer. Not all valsartan products have necessarily been affected by this valsartan cancer risk from NDMA impurity, but several of them have so far been recalled.

According to the FDA, this NDMA impurity may have been present at least at some level in valsartan drugs for as long as four years.

The FDA announced to the public in July 2018 that it had asked generic valsartan manufacturers to issue a voluntary valsartan drug recall to take it off the market in the U.S. A similar recall has been issued in 22 other countries over valsartan drugs.

Filing a Valsartan Cancer Risk Lawsuit

If you or a loved one has suffered from cancer or other side effects after taking valsartan, the NDMA impurity may be to blame, and you may be eligible for litigation. While filing a lawsuit cannot take away the side effects of contaminated valsartan, it can help compensate for the financial cost incurred by medical expenses and lost wages. Consulting a pharmaceutical products attorney can help.