On July 13, 2018, the USFDA issued its widest Class 1 Recall due to contamination of the generic blood pressure medication valsartan with the impurity N-Nitrosodimethylamine (NDMA). A known side effect of N-Nitrosodimethylamine is cancer formation. Nearly 1 in 3 Americans suffer from hypertension, and valsartan is one of the primary drugs utilized to treat this condition. If you’ve received a recall letter from Humana, you are one of approximately 2 million Americans they reached out to regarding the recall. Unfortunately, only time will tell how many Americans experience the unfortunate side effects of contaminated valsartan.
More recently, batches of irbesartan and losartan also tested positive for carcinogenic impurities.
Valsartan, losartan, and irbesartan are in the same class of angiotensin receptor blockers (ARBs). The full extent of the blood pressure medication contamination and how many other ARBs contain carcinogenic impurities is still unknown.
As more regulatory investigations continue to uncover more carcinogenic impurities, legal actions also continue to mount. Many lawsuits alleging cancer development due to valsartan impurities have now been filed across the U.S., along with many class action claims.
Valsartan Side Effects
Here is what we know: The full extent side effects and injuries caused by impurities in valsartan are being investigated.
The NDMA and other carcinogens in valsartan are rapidly absorbed in the upper part of the small intestine traveling to the liver through the portal blood supply.
The liver can effectively metabolize and clear small amounts of NDMA, allowing very little to interact with other organs. Therefore, the liver is the most susceptible organ to experience side effects from contaminated valsartan.
The side effects of long-term exposure to valsartan are not currently well understood. Our attorneys are currently evaluating claims related to those who have experienced the following side effects or injuries:
- Liver cancer
- Liver failure
- Colorectal cancer
- Pancreatic cancer
- Stomach cancer
- Bowel cancer
- Esophageal Cancer
Our valsartan lawyers will continue to investigate other cancer formations that could be related to the impurities within valsartan. Call 800-259-1005 to report a cancer formation, liver injury, or additional side effect that you think might be valsartan impurities related.
Valsartan, an angiotensin II receptor blocker (ARB), is used to help control blood pressure.
In 2005 Novartis Pharmaceuticals Corporation began selling the brand name version of valsartan Diovan. Diovan is not believed to have been contaminated with NDMA. Before the patent expired, Novartis’s Diovan profits were over $2 billion a year, peaking at $6 billion a year.
In 2012, the Diovan/valsartan patent Novartis had expired, allowing generic manufacturers to enter the highly lucrative market. Unfortunately, to further maximize their profit, generic manufacturers cut corners in the production of generic valsartan.
Mylan was the first pharmaceutical company to release a generic valsartan drug to market. The first generic valsartan sold by Mylan was a combination pill intended to compete against Novartis’ Diovan HCT (valsartan + hydrochlorothiazide). Mylan was granted a 180-day window as the sole marketer of the generic valsartan combination pill. Shortly after, Sandoz, a division of Novartis, also launched a generic valsartan + hydrochlorothiazide combination to compete against Mylan’s generic valsartan. In 2014 Sandoz further expanded its generic Valsartan market when they released a non-combination generic valsartan.
In 2015 another generic drug manufacturing giant Teva Pharmaceuticals Industries Ltd launched a non-combination generic valsartan. As the number of generic formulations of valsartan increase, so have discoveries of the cancer-causing agent NDMA.
Once valsartan went generic pharmaceutical companies, as a cost-reducing measure, started outsourcing the manufacturing process of the Active Pharmaceutical Ingredient (API) to China and India. Because the contaminate NDMA is a byproduct of the manufacturing process of the API, it is unlikely that this is isolated contamination. It is becoming increasingly clear that the majority of generic valsartan sold has significant amounts of carcinogenic impurities. Furthermore, valsartan attorneys allege that generic pharmaceutical companies were aware that the valsartan they were selling to millions of consumers was contaminated.
If you have taken a generic valsartan product and have been diagnosed with cancer, you might be eligible for compensation. The law firm of Lundy, Lundy, Soileau & South, have represented thousands of clients across the United States in cases against major manufacturers who market and sell dangerous drugs. Contact our team for a free evaluation of your case 800-259-1005