The blood pressure drug valsartan by Mylan has been associated with a risk of cancer caused by contaminants during the manufacturing process. In response, Mylan has issued a voluntary, nationwide recall of certain groups of its valsartan tablets.

Following the U.S. Food and Drug Administration’s (FDA) initial valsartan recall in July 2018 due to contamination from the impurity NDMA, the FDA has now also recalled other medications found to be contaminated with the same probable carcinogen.

Multiple Drugs Recalled Over Impurity Concerns

According to USA Today, the FDA released a statement on Nov. 1, the heartburn drug Zantac has also been recalled from the market due to NDMA contamination. In addition to valsartan, other blood pressure medications including losartan and irbesartan also appear to be affected by the contamination.

While initial testing on valsartan only indicated the presence of one impurity, follow up tests revealed that the drug may contain several impurities and contaminants, including NDMA, NDEA, and NMBA. Estimates on the number of patients affected by the valsartan impurities range from 3 million to 5 million. According to the FDA, NDMA contamination may result in increased cancer rates for patients taking these medications.

Although NDMA and NDEA are contaminants that may be found in water and common foods, these impurities should not be found in medications. Additionally, the FDA has not yet been able to determine what is causing these contaminants to appear in valsartan and other drugs. There is some speculation that the manufacturing process for these drugs may introduce the contaminant to the medication, and that manufacturing inspections may need to be more rigorous in order to catch and prevent future impurities. Other speculation includes that these medications may be unstable, break down, and chemically form NDMA and other impurities on their own.

What is Valsartan?

A cardiovascular medication, valsartan is manufactured and distributed by a number of companies, including Mylan Pharmaceuticals, Teva, and several others. Valsartan is approved by the FDA as a treatment for high blood pressure (hypertension) in adults as well as children six and up. In adults, valsartan is also approved to treat heart failure.

Valsartan belongs to a class of hypertension medications called angiotensin II receptor agonists, which are specifically used to allow the blood to flow more freely by reducing the constriction of blood vessels.

What Are Potential Valsartan Complications?

Unfortunately, the use of valsartan by Mylan could lead to serious complications because of several dangerous impurities that were discovered. One of these impurities is N-nitrosodiethylamine, or NDEA, which was reportedly found in trace amounts in recent valsartan products.

While NDEA is a substance that occurs naturally in some foods and water, it also occurs in air pollution and industrial processes, and has been classified by the International Agency for Research on Cancer (IARC) as a “probable human carcinogen”—that is, a substance capable of causing cancer in those exposed to it according to the Miami Herald.

What’s Going On with the Valsartan Recall?

Because of its link with NDEA contamination, valsartan by Mylan has been subjected to a voluntary nationwide recall by the company according to the FDA.

The recall was first issued on Nov. 20, 2018, and affected certain lots of valsartan tablets distributed in the U.S. between March 2017 and November 2018.

On Dec. 4, 2018, Mylan issued an update, noting that it had expanded its heart medication recall to include many more lots of valsartan tablets due to trace amounts of N-nitrosodiethylamine (NDEA). The expanded recall includes 104 additional valsartan lots.

The FDA is in the process of conducting a review to investigate the NDEA levels in valsartan medication in order to determine the risk that patients may face, as well as determine what steps should be taken going forward to ensure that NDEA does not contaminate future batches of valsartan.

Not all valsartan medications have been recalled.

Can I File a Valsartan Lawsuit?

If you or someone you know has suffered from side effects of valsartan by Mylan that has been contaminated with NDEA, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot undo the pain and suffering caused by valsartan side effects, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Pursuing litigation can be complicated and stressful, especially on top of health complications, so Top Class Actions has done some of the work by connecting you with an experienced attorney. An attorney can help you determine if you have an eligible valsartan claim, navigate the complexities of litigation, and maximize your potential compensation.