Valsartan recall related to cancer

Event News

Researcher: Ariana Arce​

Researcher: Ariana Arce​

a.arce@legalhelpadvisor.com

Journalist: Aaron Vivanco

Journalist: Aaron Vivanco

a.vivanco@legalhelpadvisor.com

Editor: Daniela Polo

Editor: Daniela Polo

d.polo@legalhelpadvisor.com

Contact Us

We will review your case so that we can help you become a part of the lawsuit to hold the company accountable.

Valsartan recall related to cancer

Drug manufacturers initiated recalls of valsartan due to contamination with N-nitrosodimethylamine (NDMA), a potentially carcinogenic chemical.

A class action related to valsartan has been filed in New Jersey following recent findings, with the federal court in that area handling the proceedings. There are currently >1,000 pending valsartan lawsuits in federal court.

Valsartan pills displayed on a blue background.

If you think that your valsartan-containing medication was contaminated, you might be eligible to file a lawsuit. Contact us and we will give you the free legal advice you need.

What is Valsartan?

Valsartan is a medication marketed under the brand name Diovan. It is also available in generic form, which is generally less expensive than the brand name version. All versions of Valsartan are often prescribed as part of combination therapy and are utilized for the following purposes:

  • Reduce elevated blood pressure
  • Manage heart failure and decrease the likelihood of hospitalization
  • Treat irregular heartbeat
  • Enhance post-heart attack survival

Why was the Valsartan recall issued?

The manufacturers and FDA have issued a voluntary recall of certain products due to the detection of impurities in the manufacturing process, specifically NDMA or N-nitrosodiethylamine (NDEA). This poses a risk to patients; however, not all products containing Valsartan are subject to recall.

If you suspect any adverse events related to the use of these products, you should report it promptly either by informing your doctor or through FDA’s Med Watch Program, which offers online, regular mail, or fax options.

What effects can the Valsartan contamination have on people?

Patients who have taken contaminated Valsartan may or may not experience adverse effects. However, in some rare instances, patients may develop cancer.

Animal studies have shown that consuming high amounts of NDMA can lead to liver cancer, liver disease, and other illnesses. The Agency for Toxic Substance and Disease Registry at the Centers for Disease Control and Prevention suggests that ingesting or inhaling NDMA may cause cancer in humans.

The federal government sets regulations for the acceptable NDMA, NDEA, and NMBA levels in blood pressure medications due to their potential risks. The recalled drugs were found to have higher levels of these substances.

The FDA has released a statement indicating exposure to contaminated medications dating back to 2014. According to their analysis, taking a daily dose of 320 mg of contaminated valsartan for 4 years could potentially result in an increase of one cancer case per 8,000 individuals throughout their lifetimes.

How does the valsartan recall work?

The FDA has the power to mandate product recalls based on defined criteria, including medical devices, foods, controlled substances, biological products, human cells, tissues, and cellular- and tissue-based products.

A voluntary recall is a corrective action taken by drug companies for a product that violates regulations by removing it from the market. The recalling company may take action on its own or as recommended by the FDA if a distributed product is found to violate laws.

When did the recall process start?

The FDA stated on August 30, 2018, that over half of the US supply of valsartan was recalled. The tainted drugs were believed to have entered the market in 2014. In September 2014, the agency discovered another toxic chemical called N-nitrosodiethylamine (NDEA) in the contaminated valsartan batches. NDEA, like NDMA, could potentially cause cancer.

Several Valsartan brands affected by the recall

Alembic’s valsartan with hydrochlorothiazide is excluded from the recall.

Solco is currently the sole provider of customer reimbursement services. If the medication label indicates a different manufacturer than Solco, the medication is recommended to be positioned in a secure place in case the manufacturer offers refunds in the future.

Companies that have recalled Valsartan products are listed below:

  • American Health Packaging (Aurobindo)
  • A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco)
  • Aurobindo Pharma USA Inc.
  • Aurobindo Pharma USA Inc. (Acetris)
  • AvKARE (Hetero/Camber)
  • AvKARE (Teva/Actavis)
  • Bryant Ranch Prepack Inc. (Teva/Actavis)
  • H J Harkins Company Inc., doing business as Pharma Pac (Prinston/Solco)
  • Hetero Labs, Inc., labeled as Camber Pharmaceuticals
  • Mylan Pharmaceuticals
  • Northwind Pharmaceuticals (Teva/Actavis)
  • NuCare Pharmaceuticals Inc. (Prinston/Solco)
  • Preferred Pharmaceuticals Inc. (Hetero/Camber)
  • Prinston Pharmaceutical Inc., labeled as Solco Healthcare LLC
  • RemedyRepack Inc. (Hetero/Camber)
  • RemedyRepack Inc. (Prinston/Solco)
  • RemedyRepack Inc. (Torrent)
  • Rising Pharmaceuticals Inc., labeled as Acetris Health, LLC
  • Teva Pharmaceuticals, labeled as Major Pharmaceuticals
  • Teva Pharmaceuticals USA Inc.
  • Teva Pharmaceuticals USA, labeled as Actavis
  • Torrent Pharmaceuticals Limited

You can find general information regarding this recall on the FDA website.

Risk of cancer with contaminated Valsartan products

As stated above, certain medications containing Valsartan, prescribed for hypertension and heart failure, have been recalled in the US due to a substance that may increase the risk of cancer.

According to laboratory test results, NDMA has been classified as a probable human carcinogen.

The potential long-term risks associated with NDMA found in Valsartan-containing drugs are not fully understood at this time, and the amount of NDMA consumed may affect these risks, according to Dr. Erin Michos, an associate professor and associate director of preventive cardiology at Johns Hopkins Medicine.

Other dangerous Valsartan side effects

Valsartan has been associated with serious side effects, including allergic reactions, high potassium levels in the blood, and kidney problems. Rare but significant adverse effects of Valsartan may include:

  • Acute liver injury or liver damage
  • Allergic reactions, such as hives, difficulty breathing, and tongue or throat swelling
  • Defective renal function
  • Fetal toxicity
  • Hyperkalemia (high potassium levels in the blood)
  • Impotence
  • Low blood pressure
  • Numbness or tingling in the hands, feet, or lips
  • Reduced kidney function and kidney failure (if not treated)

Before taking Valsartan, you should discuss with your doctor about potential side effects to comprehend the risks and monitor any complications.

What can you do if your Valsartan medication was contaminated?

The FDA advises patients with recalled medicine to continue taking it until a new supply is available unless instructed otherwise by their healthcare provider. Abruptly stopping the treatment may increase the risk of harm to one’s health.

It is advised to consult with your prescriber regarding the possibility of continuing the current medication or exploring alternative therapies through a new prescription. If you must keep taking your current medication, the next refill will be processed with unaffected medication.

File a Valsartan lawsuit over contaminated drug products

Those who have taken Valsartan medication from 2015 to 2019 are advised to seek immediate medical attention from their healthcare providers.

Patients who were prescribed Valsartan and later diagnosed with cancer may want to consider legal recourse against the manufacturers, marketers, and distributors of the defective drug.

Those who think they have suffered adverse effects from valsartan should consider seeking legal action. The Valsartan lawyers at Legal Help Advisor are prepared to offer their expertise to assist you.