Earlier this month the FDA announced a major recall of prescription blood pressure and heart drugs which contain the active ingredient valsartan.
Valsartan is an active ingredient that is widely used in a number of brand name and generic drugs used to treat hypertension and heart failure. It was recently discovered that when valsartan is manufactured in a certain way it can contain a dangerous impurity called N-nitrosodimethylamine (NMDA).
NMDA is a known human carcinogen. The valsartan medications containing the dangerous NMDA impurity have been linked to a specific pharmaceutical ingredient distributed by a Chinese company — Zhejiang Huahai Pharmaceuticals. Zhejiang Huahai was manufacturing the contaminated valsartan component and selling it to several U.S. pharmaceutical companies including Teva Pharmaceuticals Ltd. and Solco Healthcare. Zhejiang Huahai discovered NMDA impurities in its product which eventually led to the FDA recall.
List of Recalled Drugs
Not all drugs containing valsartan have been recalled. Only those drugs that were made with ingredients from Zhejiang Huahai. The list of all recalled drugs is below:
Drug Name Manufacturer
Valsartan Major Pharmaceuticals
Valsartan Solco Healthcare
Valsartan Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ) Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ) Teva Pharmaceuticals Industries Ltd.
What is NDMA?
NDMA is a type of chemical compound that often created as a byproduct of chemical processes that are used to manufacture various products. NDMA is created in the manufacture of rubber tires, chemical pesticides and in the processing of fish for market. A small trace amount of NDMA is often found in certain processed foods (again as the byproduct of the way the food are produced). NDMA is classified as a human carcinogen (meaning it is believed to cause cancer in humans). Numerous animal studies have established that NDMA can cause cancer in the liver, gastrointestinal system, and in the kidneys.
The FDA Recall
In July 2018 the NDMA contamination of certain valsartan products prompted a safety recall by the FDA. All valsartan products manufactured with ingredients from the Zhejiang Huahai company were immediately recalled for safety reasons. According to the FDA, the NDMA impurities in the drugs were “totally unexpected” and believed to be caused by changes in the way certain ingredients were manufactured by the company in China. The FDA is now launching a full investigation into the recalled products.
Potential Injuries from the Valsartan Products
It is very unclear how long the recalled valsartan products may have been on the market while containing the dangerous NDMA impurities. It is also not clear at this point exactly how high the levels of NDMA were in drugs. However, all of the recalled valsartan drugs are long-term “maintenance” medications that patients usually take every day for years. Therefore it is very possible that many individuals could have been ingesting drugs contaminated with NDMA on a daily basis for many years. This sort of long-term exposure to a known carcinogen creates a very serious health risk. NDMA exposure is strongly linked to certain types of cancer including:
- Liver Cancer
- Gastric Cancer
- Colorectal Cancer
- Kidney Cancer
Contact a lawyer if you have Been Taking Valsartan
If you have been taking one of the recalled valsartan drugs manufactured by Teva or Solco Healthcare, you should contact Miller & Zois to discuss whether you have a potential claim. Even if you don’t have cancer or any symptoms right now, you might become sick down the road. Get a free online consultation.