Valsartan is a highly prescribed pharmaceutical which is used to treat patients suffering from high blood pressure (hypertension) or congestive heart failure. It is classified as an angiotensin receptor blocker, or an ARB. This drug was approved for patients with hypertension in Europe in 1996 under the brand name Diovan, and gained U.S. Food & Drug Administration approval in the United States in 1997.
Since its approval, Valsartan has become a commonly prescribed drug for those suffering from hypertension or congestive heart failure. It has been so widely prescribed that, according to their internal financial reports, the drug manufacturer Novartis International sold $2.052 billion worth of Valsartan nationwide (under the trade name Diovan) and $6.053 billion worldwide. Many drugs, however, now contain the generic version of Valsartan, and are now sold by many companies in addition to Novartis, which served to spread the popularity of Valsartan. The Agency for Healthcare Research and Quality estimates that roughly 8,000,000 prescriptions for Valsartan were filled in the last year alone.
In July of 2018, after discovering NDMA in various Valsartan products, the drug was recalled by the European Medicines Agency in 22 countries in Europe, as well as Canada. NDMA has been declared a possible human carcinogen by the FDA and is also linked to liver failure. Within a month of this event, voluntary recalls were announced in the USA as well.
Those who were prescribed and paid for generic versions of Valsartan say that drug manufacturers displayed willful disregard for safety procedures.
Because Valsartan is manufactured by multiple companies in multiple countries, only some Valsartan products were recalled, dependent upon where they were manufactured and whether or not those manufacturing locations were exposed to contamination. To make this distinction clear for the public, the FDA soon released two lists to the public on its website, each with hundreds of Valsartan products, to show which were affected by the recall and which were not.
Studies published in The BMJ present evidence which suggests that Valsartan has been exposed to this contamination for years, increasing the exposure window of many patients to cancer. Because Valsartan is used to treat patients with high blood pressure or those who are at risk for heart failure, the harmful effects of Valsartan often reach the most vulnerable of our population. The American College of Cardiology and the American Heart Association report that roughly 103 million US adults had hypertension in 2017, and that 36% of these individuals should be taking medication to treat it.
Many of those infected may have been taking Valsartan for years, and have only discovered within the past year that their medication has put them at risk. Many have had to switch to a different ARB at the recommendation of their physicians, as it can be dangerous for such patients to go without treatment.
If you or a loved one has been affected by cancer after taking Valsartan, please contact us for a free, no-risk case evaluation. We might be able to get you compensation in a Valsartan lawsuit.
How Does Valsartan Work?
Angiotensin II is a bodily chemical that causes the muscles around your blood vessels to contract. When muscle contraction happens, the vessels themselves become narrower, increasing the amount of pressure and leading to a higher blood pressure, or hypertension.
Valsartan falls into the category of an ARB, or an angiotensin-receptor blocker. As its name suggests, the function of an ARB is to selectively block the action of angiotensin II by preventing it from binding to those receptors. Typically, this connection is what causes muscle contraction, but once Valsartan is taken and the connection is blocked, blood vessels dilate (become larger), making it easier for blood to flow through them and reducing blood pressure.
Valsartan is one of many drugs which functions in this way. For patients with hypertension or congestive heart failure, the use of an ARB like Valsartan is essential to regulate and reduce blood pressure, which significantly reduces the likelihood of congestive heart failure as a result. It is not recommended by physicians that patients stop taking their ARB or else they may put themselves at risk.
What Are Valsartan’s Approved Uses?
Valsartan has been approved for the following uses by the FDA:
- Treatment of high blood pressure (hypertension)
- Treatment of congestive heart failure
- Can be prescribed after a patient suffers a heart attack to prevent future danger
The Controversy Surrounding Valsartan
In July 2018, multiple drugs containing Valsartan were part of a voluntary recall caused by the discovery of an impurity in the drug which is classified by the FDA as a possible carcinogen. The American recall came on the tails of 22 European countries and Canada issuing recalls of 2,300 batches of contaminated Valsartan. According to reports from USA Today, the FDA has been able to trace this contamination to specific manufacturing sites in China and India.
NDMA has been declared a possible human carcinogen by the FDA and is also linked to liver failure.
The impurity initially found in Valsartan is called N-nitrosodimethylamine, or NDMA, an organic chemical that the FDA classified as a probable human carcinogen. This chemical is used in liquid rocket fuel, lubricants, and other products, and sometimes is created as a byproduct from pesticide manufacturing. In addition to its categorization as a possible carcinogen, the EPA claims that NDMA may cause liver damage at high enough levels.
Because only certain manufacturers were found to have produced contaminated Valsartan, some products which contain this drug have been unaffected by the recall. A complete list of products which are and are not affected by the recall in the United States can be found through the FDA, which has released these lists to the public via their website.
Why Are Valsartan Patients Filing Lawsuits?
Some Valsartan lawsuits in the United States have begun to mobilize since the discovery of the drug contamination in 2018. Those who were prescribed and paid for generic versions of Valsartan say that drug manufacturers displayed willful disregard for safety procedures at the plant where contamination went undiscovered for years until it was revealed by random testing.
If you are a former Valsartan patient who received a cancer diagnosis after taking the drug, please consider contacting us to get connected with a knowledgeable attorney about your options. It’s not too late to take legal action, but it’s important to act quickly to preserve your rights.