A current lawsuit investigation is looking for individuals who have developed cancer after taking valsartan medicine or a combination of valsartan and another medication.

Patients who took valsartan medicine, prescribed to treat heart failure, post-heart attack recovery, and high blood pressure, may have been at risk for developing cancer due to a contaminant found in the medication. After the contaminant was discovered, some valsartan products have also been recalled off market shelves.

Overview: Valsartan Medicine

Valsartan is an antihyperentensive drug that is prescribed to treat high blood pressure and heart failure. It can also be prescribed to help reduce death risks after a heart attack. However, due to issues at a manufacturing facility, the generic equivalent of Diovan may put patients at risk for cancer development.

Valsartan medicine was approved by the U.S. Food and Drug Administration (FDA) on Aug. 14, 2002. It is a part of a class of medications known as angiotensin II receptor agonists that helps dilate blood vessels to allow for the more free flow of blood. Valsartan medicine may be available as valsartan HCTZ, which combines the drug with the diuretic hydrochlorothiazide, or as a stand-alone medication.

There are many manufacturing companies that package and distribute valsartan, such as Teva Pharmaceuticals and Major Pharmaceuticals. However, an announcement was made by the European Medicine Agency in May 2018 that discovered a possible contaminant in valsartan medications stemming from a Chinese pharmaceutical manufacturer, Zhejiang Huahai Pharmaceuticals. The contaminant was found to be N-nitrosodimethylamine, or NDMA, determined and classified as a “probable human carcinogen” by a number of healthcare authorities.

To help protect patients from a potential carcinogen, the medication was pulled off market shelves by national regulators across Europe. United Kingdom officials did the same, pulling the stand-alone medication along with valsartan HCTZ from consumer reach.

The U.K.’s Medicines and Healthcare Products Regulatory Agency noted that NDMA presence was caused by the way of production of the drug as far back as 2012 at its manufacturing facility in china. Thus, while the contaminant issue has only been recently found, a contaminated valsartan medicine may have potentially been on market shelves for years.

In the U.S., the FDA asked three of the drug’s manufacturing companies to voluntarily recall the drug in July 2018. The FDA also asked pharmacists to remove affected valsartan general medicines from their inventories and return them to manufacturing facilities.

There is a current ongoing investigation by the FDA looking into NDMA levels in valsartan medicine. They are hoping to evaluate the cancer risks valsartan patients may face, as well as define potential steps to help reduce the number of contaminated valsartan products manufactured by Zhejiang Huahai Pharmaceuticals in the future.

It should be noted that not all valsartan products have been recalled. The FDA says it will keep patients and physicians informed as new companies are added to the valsartan recall.