FDA Recalls Some Valsartan Medications

Valsartan Medication BottleHigh blood pressure and heart failure are chronic conditions that are often treated with lifestyle changes and prescription medications. Valsartan, or Diovan, is one of the medications used to treat high blood pressure and congestive heart failure, but certain lots of valsartan have been contaminated with a carcinogenic chemical that could cause cancer in people who have taken the medication.

How Valsartan Works

Diovan is an angiotensin II receptor blocker (ARB). Angiotensin II is a hormone that can cause blood vessels to narrow and contribute to high blood pressure or heart failure. Diovan blocks angiotensin II to prevent blood vessels from narrowing and to improve blood flow.

The first brand name version of Diovan was valsartan. Valsartan, manufactured by Novartis, was first approved by the Food and Drug Administration (FDA) in 1996. The valsartan patent expired in 2012, and now there are many generic forms of the medication.

2018 Valsartan FDA Recall

In July 2018, the FDA recalled valsartan made by Zhejiang Huahai Pharmaceutical Co. The recalled valsartan was sold to large pharmaceutical makers, and it was used as an ingredient in other heart medications. Some of the pharmaceutical companies impacted by the recall include Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd.

The recall occurred because N-nitrosodimethylamine (NDMA) was found in the valsartan. NDMA is a carcinogenic chemical that has been linked to liver problems and cancer in rats. NDMA was not intentionally placed in valsartan, but was found to be contaminated by the chemical.

Several other countries recalled valsartan in July 2018. For example, the European Medicines Agency announced a recall in the European Union on July 5, 2018, the Hong Kong Department of Health announced a recall on July 6, 2018, and Health Canada issued an advisory communication on July 9, 2018.

Since July 13, 2018, the FDA has issued more than 40 press releases, statements, or updates regarding the Valsartan recall.

Are You at Risk?

Since the NDMA contamination of valsartan impacted different batches of different medications, it is important to talk to your doctor if you are taking prescription medication to treat high blood pressure or a heart condition. Your doctor and your pharmacist can confirm whether or not you took medication that may have been contaminated with NDMA.

Evidence suggests that NDMA may have contaminated valsartan batches for as long as four years before the 2018 recall. If you used valsartan since 2015, then you could be at risk of suffering a liver injury, liver cancer, kidney cancer, stomach cancer, pancreatic cancer, colorectal cancer, or another type of cancer.

You did not expect to ingest NDMA when you were taking your blood pressure or heart medication. Unfortunately, that is what happened, and it may have been happening for years. Your individual risk of developing cancer may not be known, but it is a risk that you did not knowingly take and that you should never have had to take.

Valsartan Lawsuits

Valsartan injury cases are just getting started. As of April 2019 dozens of lawsuits have been filed, and lawyers expect that this just the tip of the iceberg. One lawyer reportedly told a conference of federal judges that he expected approximately 2,000 cases to be filed within the next two years. 

Additionally, many people have been exposed to NDMA who may not develop cancer right away. Currently, federal multi-district litigation (MDL) is pending. The goal of the MDL case is to create a fund that would pay for medical monitoring, cancer screenings, and if necessary cancer treatment for valsartan users who may develop cancer in the future.

You couldn’t have known that your medication was contaminated with NDMA or that you were at risk of developing cancer from this contaminant. However, now that you know that your medication was tainted with this carcinogen, you can make an informed decision about what to do next.

Call our medication injury lawyers today to schedule your free case consultation, to learn more about how you can protect your rights, and to find out what you may recover in a lawsuit or settlement.

 

John L. Keefe
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