The chemical known as N-Nitrosodimethylamine (NDMA), which has been classified as a probable carcinogen in humans, has reportedly been found in the blood pressure medication valsartan. People are concerned that their valsartan dosage may have included dangerous amounts of this substance.

What is NDMA?

N-Nitrosodimethylamine (NDMA) is tasteless, odorless, dissolves in water, and is classified as a probable carcinogen in humans. NDMA is the most toxic to the liver.

NDMA is no longer used industrially, although it can form due to industrial processes at certain factories. The FDA considers one microgram (or one-millionth of a gram) of NDMA “reasonably safe” to consume per day.

How Much NDMA is in each Valsartan Dosage?

A little over a year ago, in July 2018, the U.S. Food and Drug Administration (FDA) announced that widely used blood pressure medications containing valsartan had been found to have impurities containing the carcinogenic NDMA.

The FDA quickly began overseeing a valsartan recall from three major pharmaceutical companies with valsartan-based blood pressure drugs that had been affected. All three of these companies purchased the active ingredient for valsartan from a major generic drugmaker in China, Zhejiang Huahai Pharmaceutical Co. Since that initial announcement, the recall has been expanded dozens of times to include similar drugs from other companies.

Unfortunately, millions of people in 30 countries across the globe could have been affected. And the risk could be severe.

Indeed, while the FDA considered one microgram to be the maximum consumable amount to be “reasonably safe,” some of the contaminated valsartan drugs have been found to have as much as 17 micrograms in a single pill.

The FDA has estimated that for every 8,000 people who took the highest dose of this contaminated valsartan dosage every day for four years, one additional person would be diagnosed with cancer. Regulators in Europe put the risk higher, estimating that one out of ever 3,390 might develop cancer as a result.

The impurity problem was discovered when an FDA inspector visited in May 2017 and noticed a slew of concerning signs: old, rusty machinery, testing anomalies being dismissed, and customer complaints being ignored. This led the inspector to report that the company was ignoring signs of contamination in its products, causing the FDA to demand that drugmakers look for NDMA impurities in their valsartan.

According to Bloomberg, “Valsartan is just the one we caught,” said David Gortler, a former FDA medical officer, who now consults about drug safety. “Who knows how many more are out there?”

Filing a Valsartan Lawsuit

If you or someone you love has developed cancer after exposure to a valsartan-based drug, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by cancer, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, especially in the wake of a cancer diagnosis or a loved one’s death, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.