Valsartan, a popular prescription drug used to treat hypertension and other heart conditions, may be causing cancer in patients. It was recently discovered that certain ingredients used to manufacture Valsartan were contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to cause cancer in humans. The FDA and European health officials promptly issued global safety recalls of contaminated Valsartan products.
Contamination of Valsartan with NDMA
In July 2018, the Chinese company Zhejiang Huahai Pharmaceuticals, one of the leading manufacturers of generic valsartan, first discovered that the raw Valsartan it was producing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical production lab that manufactures valsartan and distributes it through U.S. affiliates Prinston, Huahi and Solco. The company synthesizes the Valsartan compound and wholesales it to major pharmaceutical companies around the world who then use it to manufacture, package and sell their own generic versions of Valsartan. Zhejiang Huahai was by far the largest wholesale producer of Valsartan compound. In June 2018, quality control tests at Zhejiang Huahai revealed that the batches of Valsartan it was producing were dangerously contaminated with N-nitrosodimethylamine (NMDA). The presence of NDMA was totally unexpected. The NDMA contamination was apparently caused by a change in the method of synthesizing the drug that Zhejiang Huahai had adopted several years earlier.
The discovery raised serious safety concerns because of the known dangers of NDMA. NDMA is a well-known byproduct of certain chemical manufacturing processes. NDMA is classified as a carcinogen because it is known to cause cancer in humans. Numerous animal studies have established that exposure or ingestion of even small amounts of NDMA can cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the manufacture of rocket fuel, but this use was stopped because of concerns about environmental contamination. The EPA classifies NDMA as a probable human carcinogen. NDMA is identified as a priority toxic pollutant in federal regulations.
After discovering the NDMA contamination, Zhejiang Huahai immediately alerted pharmaceutical companies and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health officials to immediately recall all potentially affected versions of Valsartan. Since then, NDMA contamination has been found in the valsartan components produced by 2 other pharmaceutical wholesalers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Testing on the components from these labs showed lower levels of NDMA compared to the Zhejiang Huahai product.
Potential Injuries Associated with Contaminated Valsartan
NDMA is not only a particularly dangerous carcinogen, but it can also be a poison at high levels. There have been several reported cases in which people died from internal bleeding and severe liver damage after ingesting high doses of NDMA on just one occasion. In animal testing, ingesting high to moderate levels of NDMA caused major liver damage after just a few days and cancer after just several weeks. Almost all of the animals
An investigation into the cause of the NDMA contamination has shown that it was most likely caused by a change in the manufacturing process that Zhejiang Huahai started several years ago. This means that Valsartan contaminated with NDMA was on the market for several years before its discovery and recall. This is very concerning since Valsartan is used as a “maintenance” drug which is taken daily on a long-term basis. This means that some people may have been ingesting NDMA once or twice a day over several years. The continuous long-term use is exactly the type of exposure that can cause cancer. NDMA exposure is linked to specific cancers such as:
- Liver Cancer
- Gastric Cancer
- Colorectal Cancer
- Kidney Cancer
What Patients Need to Know
If you were prescribed Valsartan for treatment of hypertension or other conditions, you should immediately consult with your prescribing doctor about the potential dangers to your health. You should also find out what generic version(s) of Valsartan you were getting from your pharmacy. Please note that not all generic versions of Valsartan were contaminated with NDMA, however the recall list continues to grow as the investigation proceeds. In the U.S. the safety recall only applied to the Valsartan manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.
Contact Capretz & Associates About Valsartan
If you or a loved one were prescribed Valsartan to treat high blood pressure or other conditions, you may have been injured by the NDMA contamination.
We are currently reviewing cases where there has been a diagnosis of liver, stomach, or colorectal cancer. The early evidence is that these particular cancers are associated with the contaminated Valsartan.
We are also investigating liver injury cases if the patient has had at least three days of hospitalization that occurred within 30 days of taking the contaminated Valsartan.
We are not reviewing bladder, kidney, or pancreatic cancer cases at this time because the evidence is not currently supportive of an association with contaminated Valsartan.
Contact the attorneys at Capretz & Associates today. We provide free consultations and can help investigate your case to determine whether you might have a valid claim.
Call us at 800-351-8588 or click on the gold “Contact the Firm” button on the right and a Valsartan team member will get in touch with you.