Several lots of valsartan HCTZ, a popular blood pressure medication, have been recalled by the manufacturers due to concerns over possible contamination with a carcinogenic industrial chemical. The medications in question include amlodipine valsartan as well as amlodipine valsartan in combination with hydrochlorothiazide.

The chemicals in question are known as N-Nitrosodimethylamine (NDMA) and N-nitrosodiethylamine, (NDEA). Traces of these substances have been found in valsartan HCTZ and other “sartan”-containing prescription medications from a number of pharmaceutical companies. The U.S. Food and Drug Administration has determined both of these industrial chemicals to be potential human carcinogens, even in small amounts.

Valsartan HCTZ and Other Sartan Drugs

Valsartan HCTZ is part of a class of blood pressure medications called “angiotensin II receptor antagonists,” or ARBs for short. These drugs operate by inhibiting the action of the hormone angiotensin II, which causes blood vessels to constrict. They are indicated for patients suffering from hypertension and congestive heart failure. Valsartan HCTZ and similar drugs are also used to delay the progress of end-stage kidney disease in type-2 diabetics. These medications are known to cause fetal toxicity and are not recommended for pregnant women.

Other commonly-prescribed drugs in this class include:

• azilsartan (Edarbi)
• candesartan (Atacand)
• eprosartan (Teveten)
• irbesartan (Avapro)
• losartan (Cozaar)
• olmesartan (Benicar)
• telmisartan (Micardis)

Of these, only valsartan, irbesartan and losartan are reportedly at risk for containing NDMA or NDEA.

About Valsartan HCTZ Contamination

NDMA is a chemical that is a by-product of numerous industrial processes, and is found in the production of latex, rubber, industrial lubricants and jet fuel. It also occurs in trace amounts in smoked and cured meats. NDEA and NDMA are classified as nitrosamines. These chemicals are known to be extremely toxic, particularly to the liver. Outward symptoms of exposure include abdominal cramps, dizziness, fever, headaches, nausea and vomiting.

The valsartan HCTZ and amlodipine valsartan found to be contaminated contains an active ingredient produced at manufacturing facilities in China and India. In September, 2018, the Zhejiang Huahai Pharmaceutical Company Co. Ltd. (ZHP) was placed under an import alert by the FDA following an inspection of the plant. Because of this alert, products from ZHP are no longer allowed to enter the U.S. Currently, all sartan drugs are undergoing testing for NDEA and NDMA contamination.

How Did the Contamination Occur?

The contamination of amlodipine valsartan, valsartan HCTZ and similar medications appear to have been the result of changes in the manufacturing process that ZHP put into place several years ago. The changes were intended to streamline the process; however, those modifications reportedly resulted in a chemical reaction between the various ingredients that caused the formation of NDEA.

If You Have Taken Valsartan HCTZ

If you believe you may be at risk or have taken a contaminated valsartan drug and developed cancer, you may be eligible to file a lawsuit against the drug manufacturer. An experienced pharmaceutical litigation lawyer may be able to help you in recovering medical expenses, loss of income and other damages allowed by law.