Has All Valsartan Been Taken Off the Market?

The FDA has announced a recall of certain lots of blood pressure drugs containing valsartan and irbesartan because they are potentially contaminated with chemicals that cause cancer. This has led consumers to wonder whether all valsartan drugs are contaminated and subject to recall.

These chemicals are known as NDEA and NDMA, and today have been known to potentially cause cancer in animals.

Not all lots of irbesartan or valsartan were impacted by the recall.

What Is Valsartan?

Valsartan is a popular generic blood pressure medication. A number of companies manufacture and distribute generic valsartan, including Teva Pharmaceuticals, Mylan Pharmaceuticals, Major Pharmaceuticals, and more. The U.S. Food and Drug Administration (FDA) has approved valsartan for use in adults and children age six and up.

Unfortunately, a number of valsartan drugs have been contaminated with an impurity known as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which reportedly may increase a patient’s risk of developing cancer.

These blood pressure medications can be dangerous to stop without oversight from a physician. Many of the blood pressure drugs that have been recalled are already off the market and other forms of medication are available.

Where Have the Recalled Valsartan Batches Come from?

Irbesartan and valsartan are generic drugs. The contamination affecting recalled valsartan relates to batches that were manufactured in India and China and in some cases have been labeled under the names of the suppliers in the United States.

It is important to recognize that the brand name versions, Avapro and Diovan, have not yet been recalled. The FDA currently maintains a website listing those drugs that have not yet been recalled.

When Did the Concern Over Valsartan Begin?

According to some claims, the Chinese drugmaker ZHP has been selling potentially contaminated valsartan dating back to 2012. Authorities in Europe and the United States originally discovered this contamination in 2018, leading to worldwide recalls of the potentially contaminated drugs.

While there are over 40 versions of the blood pressure drug that are not contaminated, the FDA also approved a new generic version of the medicine to help with the shortages caused by the recalls.

What Are the Impurities in the Drugs?

While these impurities do not affect all valsartan drugs, the recalled products may contain NDMA, NDEA or NMBA in levels that are higher than deemed safe by the FDA.

NDMA is a tasteless and odorless chemical that dissolves in water, and has been classified as a probable human carcinogen—that is, a substance capable of causing cancer in humans. The FDA considers up to one microgram (one-millionth of a gram) of NDMA “reasonably safe” to consume per day, but more than that, the agency has deemed a risk. According to reports, some of the contaminated valsartan drugs have contained as much as 17 micrograms in a single pill.

Furthermore, one online pharmacy initiated an FDA petition in the summer of 2019 claiming that they had also found DMF in specific valsartan products. DMF has been listed as a probable carcinogen by the World Health Organization recently.

According to additional investigations, the drug impurities could be caused by the use of solvents in the manufacturing process that happens when certain reaction conditions and chemicals are used to make the drugs.

What Is the Risk Factor with Contaminated Valsartan?

CNN explains that not all valsartan batches have been recalled, because some were produced without the manufacturing problems that allegedly led to the contamination of the drug. Reportedly, the FDA does not yet know how the manufacturing process went wrong in such a way that led to the drugs being contaminated.

The FDA is still investigating the manufacturing problems, but has snared drug manufacturers about possible contamination risks, and has urged valsartan markers to take proactive steps to insure that such a contamination does not affect future valsartan batches.

Unfortunately, the United States was not the only country that had to recall valsartan over the alleged impurities — 23 countries in total have recalled valsartan over the contamination risk, impacting valsartan made by multiple drug manufacturers. 

It is not yet fully known the long term cancer risks for the impurities associated with the recalled products. The FDA, however, says the danger is not great. The agency has estimated that out of 8,000 individuals taking the highest possible dose of valsartan out of a recalled batch every single day for four years, one additional cancer case would happen over the lifetimes of those people.

The FDA also updated this warning stating that the actual risk for potential patients was much lower than estimates.

However, the FDA has determined that an acceptable daily amount of NDMA to be ingested is 96 nanometers per tablet. Some consumers have filed valsartan lawsuits alleging that the amount of NDMA present in valsartan tablets is as much as 200 times the daily acceptable amount of 96 nanogram per tablet.

Regardless of this fact, many consumers have expressed concerns to their physicians about taking any form of all valsartan drugs that could be potentially contaminated. Other consumers have filed valsartan lawsuits.

The FDA does advise patients concerned about the NDMA cancer risk not to stop taking their medications in light of the valsartan recall unless their doctors have recommended it. However, patients whose doctors do recommend that they stop taking their valsartan because of contamination risks may be able to turn to drugs similar to valsartan or to those lots of valsartan not included in the recall and not deemed to be at risk for the impurities, explains CNN.

Filing a Valsartan Lawsuit

If you think that you were exposed to potential health issues by using contaminated forms of valsartan, you should speak with an attorney about your next steps. 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 these complications, 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 while dealing with a cancer diagnosis or other health complications, 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.