After the recent voluntary valsartan recall due to contamination, many patients may be wondering what medications are actually valsartan combination drugs and what may have been affected by the contamination or by the recall

What is Valsartan?

Valsartan is a popular generic blood pressure medication manufactured and distributed by a number of companies, including Teva Pharmaceuticals, Major Pharmaceuticals, Mylan Pharmaceuticals, and more.

Medicine Net explains that valsartan, known also by its brand name, Diovan, is one of a category of drugs called angiotensin receptor blockers (ARBs). ARBs like valsartan work by reducing the reception of a chemical that narrows blood vessels. If working correctly, these drugs help dilate blood vessels, reduce blood pressure, and reduce the risk of congestive heart failure.

The drug was approved by the U.S. Food and Drug Administration in December 1996. Valsartan was approved by the FDA for use in both adults and children age six and up.

Broadly, valsartan and valsartan combination drugs can be used to treat high blood pressure and heart failure. In some cases, it may be used in treatment plans for patients after they have had a heart attack, because it can help reduce the risk of death from congestive heart failure that can occur after a heart attack. In the case of those patients who have already developed congestive heart failure, the drug can reportedly reduce hospitalizations.

For patients using valsartan, maximum blood pressure reduction occurs after a patient has been taking the drug for four weeks, says Medicine Net. The dosage for the drug can vary based on the patient’s situation, and based on if they are taking it for high blood pressure, congestive heart failure, or treatment after a heart attack.

Happily, valsartan is commonly tolerated well by most patients, explains Medicine Net. AS with most drugs, there is a risk for some side effects with the use of valsartan. The most common side effects associated with valsartan include nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, and a cough. Some less common, but more serious side effects include impotence, reduced kidney function, allergic reactions, and hyperkalemia.

Basics of the Valsartan Recall

Recently, a number of valsartan drugs have been involved in a major voluntary recall after contamination with an impurity known as N-nitrosodimethylamine (NDMA), which has potentially dangerous consequences, at manufacturing plants in China and India.

As of March 2019, the FDA was still evaluating various valsartan-containing medications for contamination and impurities.

What is NDMA?

N-nitrosodimethylamine (NDMA) is a chemical that is tasteless, odorless, and dissolves in water; it has also been classified as a probable carcinogen in humans—that is, capable of causing cancer.

While the FDA considers one microgram (one-millionth of a gram) of NDMA “reasonably safe” to consume per day, more than that can lead to health risks, and some of the contaminated valsartan drugs have reportedly been found to have up to 17 micrograms in a single pill. Therefore patients who took certain contaminated valsartan drugs may be at an increased risk of developing liver damage or even cancer.

In the U.S. market, starting July 2018, the FDA announced that three major U.S. manufacturers would voluntarily recall their valsartan-based drugs. These were companies whose drugs had shown impurity levels above the acceptable limits, the agency found.

What is NDEA?

NDEA is N-nitrosodiethylamine, a chemical created as a byproduct during some manufacturing processes. The WHO has deemed NDEA a “probable carcinogen.”

How did NDEA or NDMA get in the valsartan and valsartan combination drugs? The FDA indicates that inappropriate manufacturing processes may result in drug contamination.

In November 2019, the FDA sent a letter to Mylan Pharmaceuticals Inc., a drug manufacturing company based in India. The FDA had asked Mylan to produce a written protocol to handle the testing and handling of valsartan API when the FDA had visited the plant in May 2019. The company was faulted in a Nov. 5, 2019 letter for failing to comply with the request, according to Fierce Pharma.

In late 2018, more than 100 lots of valsartan API were found to contain “low levels of NDMA” and Mylan was told to complete FDA Form 483 to outline a plan to correct the issue of contamination, which the FDA said Mylan failed to do.

“Multiple contract manufacturers supplied solvents that were contaminated with nitrosamines, but your firm lacked documentation of which tanks were used to store these solvents,” the FDA told Mylan.

Aurobindo Pharma’s plant in India also received a letter from the FDA regarding the presence of NDEA in 80 recalled lots of valsartan. The letter referenced the use of solvents used in the production of drugs that caused the medication to absorb unacceptable levels of NDEA.

Lantech Pharmaceuticals was also warned about drug production methods that could leave the opportunity open for contamination by impurities.

What are the Valsartan Combination Drugs?

There are a number of drugs that contain valsartan:

• Aliskiren/valsartan systemic, known as Valturna
• Amlodipine/hydrochlorothiazide/valsartan systemic, sold as Exforge HCT
• Amlodipine/valsartan systemic, known as Exforge
• Hydrochlorothiazide/valsartan systemic, known as Diovan HCT
• Nebivolol/valsartan systemic, known as Byvalson
• Sacubitril/valsartan systemic, known as Entresto

It should be noted that not all drugs containing valsartan have actually been recalled in the U.S. A full list of the recalled valsartan drugs can be found on the FDA’s website.

Can I File a Valsartan Lawsuit?

Blood pressure medications are prescribed for a reason; do not stop taking valsartan until you consult with your doctor.

However, if you or someone you love has been diagnosed with cancer or suffered other side effects as a result of exposure to contaminated valsartan or valsartan combination drugs, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot undo 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 an daunting prospect, especially after a serious diagnosis, 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.