On July 13, 2018, the Food and Drug Administration (FDA) recalled Valsartan because they contain the contaminant N-Nitrosodimethylamine (NDMA). The FDA noted that valsartan products pose an unnecessary risk to patients. There are seven things you should know about this recent recall.
What is NDMA?
NDMA is a contaminant. According to the EPA, it is a semivolatile organic chemical. It can be either naturally occurring or synthetically made. It is not currently produced in the United States. NDMA can be unintentionally produced through chemical reactions, especially those that involve alkylamines. It is also an intended by-product of chlorination of wastewater through the use of chloramines. These chloramines are used to disinfect the water. There is a risk that NDMA is a possible drinking contaminant.
In October 2019, we now know that NDMA is not limited to Valsartan. NDMA is also reported to be causing cancer in people taking Zantac.
How harmful is NDMA?
So exactly how harmful is NDMA? Unfortunately, we do not know to answer to this question yet. Studies involving NDMA have shown results that appear inconclusive for now. A Danish study found no short-term risk of cancer in patients using NDMA-containing valsartan. The study focused on a six-year period. However, they felt these results did not necessarily mean that NDMA is completely safe. They note that “assessment of long-term effects was not possible” and that “the low number of events makes interpretation of estimates for single cancer outcomes difficult.” They concluded that further studies are needed to provide better conclusions on NDMA’s effects on the body.
What has a U.S. government agency said on NDMA? According to the CDC, they do not know how harmful NDMA found in water, air, or food is to humans. However, they then mention that “short-term or long-term exposure of animals is also associated with serious effects such as liver disease or death.” This can happen at NDMA levels ranging from 5 to 50 ppm in water and 5 to 100 ppm in food. What this means is there is data that shows that exposure to NDMA can harm other animals. However, there is no known data that shows a significant correlation between NDMA exposure and cancer incidences.
Another harmful contaminant in Valsartan
NDMA is not the only contaminant found in valsartan you should be concerned about. Contaminated valsartan products also contain N-nitrosodiethylamine (NDEA). Like NDMA, NDEA is classified as a possible human carcinogen. You can read more about NDEA’s presence in valsartan by clicking this link.
Manufacturers and distributors of recalled valsartan
Chinese-based pharmaceutical company Zheijiang Huatai Pharmaceuticals (ZHP) has manufactured much of the recalled valsartan. They gave them to various distributors throughout the U.S. market. They include Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceutical Industries. You can also find out each distributor by clicking on this link that includes all currently recalled valsartan.
Not all valsartan products contain NDMA
Not all valsartan products contain NDMA. The FDA has a list of valsartan products not currently recalled. They update this list frequently.
What recommendations has the FDA made?
The FDA recommends that patients using recalled valsartan should continue taking their medicine until their doctor or pharmacist has provided a replacement or different treatment option. However, they also recommended that doctors use valsartan not affected by the recall. In addition, they suggested other treatment options. The FDA recommends that healthcare professionals and patients should report any adverse side effects related to valsartan use to the FDA’s Watch Safety Information and Adverse Event Reporting Program.
7. Recent Lawsuits involving Valsartan
There have been two lawsuits filed over Valsartan against ZHP and the various distributors of the contaminated valsartan. One was filed in New York. The other was filed in Missouri. Both of them note that the plaintiffs had experience injury from taking valsartan. They also mention that the defendants have failed to mention that the valsartan was contaminated with NDMA.
You can read more about both these lawsuits by clicking this link.
8. You Could Have a Legal Claim
If you are one of the thousands of people that have been taking Valsartan to treat high blood pressure or other conditions, you may have been injured by the NDMA contamination. Thousands of lawsuits will probably be filed over the Valsartan contamination. If you think you may have been harm by contaminated batches of the drug, contact the attorneys at Miller & Zois today. We can help investigate your case and determine whether you might have a valid claim. Call us at 800-553-8082 today or get a free online consultation.