Serious Injuries Linked to Valsartan

Why are Certain Valsartan Medications Being Recalled?

Valsartan LiverOn July 13, 2018, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of several medications that contain valsartan. The recall was initiated after the discovery of the presence of a contaminant N-nitrosodimethylamine(NDMA) in the recalled drugs. NDMA is classified as a probable human carcinogen which means that it is more likely than not to cause cancer in humans. The contamination of the valsartan-containing drugs has been traced to the Chinese company Zhejiang Huahai Pharmaceuticals, the producer and supplier of the valsartan in the recalled drugs.

The FDA has issued several updates regarding this recall (see the list below). Not all valsartan-containing drugs are included in the recall.

The FDA has issued the following warning:

The FDA reminds consumers to continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option. Untreated hypertension (high blood pressure) leads to an increase in the risk of heart attacks and stroke. Untreated heart failure increases the risk of hospitalization and death.

Cancers Associated with Exposure to NDMA

NDMA has been studied in animal populations and found to increase the occurrence of cancer in the animals. In light of these studies, the U.S. Environmental Protection Agency classifies NDMA as a probable human carcinogen. The studies have raised the specter of an association between NDMA and liver toxicity which can lead to the development of liver cancer and other related conditions brought about by an NDMA-induced “insult” to the liver. NDMA is also believed to be associated with the following other cancers:

  • Colorectal Cancer
  • Intestinal Cancer
  • Colon Cancer
  • Stomach Cancer
  • Kidney Cancer

The degree and duration of human NDMA exposure that can lead to the development of cancer is not precisely known. Similarly, the extent and duration of the NDMA contamination of valsartan are not precisely known. Efforts are underway to define the scope and degree of the NDMA contamination. The FDA reports that “some levels of the impurity [NDMA] may have been in the valsartan-containing products for as long as four years.”

The FDA’s List of Recalled Valsartan Medications (as of January 18, 2019)

The FDA had published and updated a detailed list of specific valsartan-containing medications that are subject to recall. Because these drugs are produced in multiple dosage strengths, not all of a manufacturers products may be subject to recall. The manufacturers whose products are on the recall list include:

  • Teva Pharmaceuticals - amlodipine-valsartan
  • Teva Pharmaceuticals - amlodipine-valsartan-hydrochlorothiazide combination tablets
  • Teva Pharmaceuticals labeled as Major Pharmaceuticals
  • Teva Pharmaceuticals USA labeled as Actavis
  • Prinston Pharmaceuticals labeled as Solco Healthcare, LLC
  • RemedyRepack, Inc. (Prinston/Solco)
  • AvKARE
  • A-S Medication Solutions, LLC
  • Bryant Ranch Pre-Pack, Inc.
  • H.J. Harkins Company d/b/a Pharma Pac
  • Proficient RX, LP
  • Northwind Pharmaceuticals
  • Camber Pharmaceuticals, Inc.
  • NuCare Pharmaceuticals, Inc.
  • RemedyRepack, Inc (Hetero/Camber)
  • AvCARE (Hetero/Camber)
  • Preferred Pharmaceuticals, Inc.
  • Torrent Pharmaceuticals, LTD
  • RemedyRepack, Inc. (Torrent)
  • Aurobindo Pharma USA, Inc. - Amlodipine and Valsartan Tablets
  • Aurobindo Pharma USA, Inc. - Valsartan and Hydrochlorothiazide Tablets
  • Aurobindo Pharma USA, Inc. - Valsartan HCTZ Tablets
  • Aurobindo Pharma USA, Inc. - Valsartan Tablets
  • Denk-Pharma GmbH & Co. KG - Amva Denk 10/160 Tablets (Amlodipine 10mg and valsartan 160mg)
  • Denk-Pharma GmbH & Co. KG - Amva Denk 5/160 Tablets (Amlodipine 5mg and valsartan 160mg)
  • Denk-Pharma GmbH & Co. KG - Amva Denk 5/80 Tablets (Amlodipine 5mg and valsartan 80mg)

Irbesartan Distributed by Solco Healthcare Voluntarily Recalled

Update [1/18/2019]: The FDA is alerting patients and health care professionals to a voluntary recall of one lot of irbesartan and seven lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets distributed by Solco Healthcare LLC, a Prinston Pharmaceutical Inc. subsidiary. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the irbesartan active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals (ZHP).

The list of Solco recalled products is here:
https://www.fda.gov/downloads/Drugs/DrugSafety/UCM629626.pdf

Valsartan Recall Update – January 1, 2019

On December 31, 2018, Aurobindo Pharma USA, Inc. announced a recall of 80 lots of its valsartan drug marketed under the names:

  • Amlodipine and Valsartan Tablets
  • Valsartan and Hydrochlorothiazide Tablets
  • Valsartan HCTZ Tablets
  • Valsartan Tablets

According to the recall notice and FDA, “Patients who [are] prescribed… [these medications]…should continue taking their medication…[and] should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.”

The recall was initiated after the company detected “trace amounts” of N-nitrosodiethylamine (NDEA) in certain lots of its valsartan medications. NDEA is identified as a probable human carcinogen by the International Agency for Research on Cancer (IARC). It presence in other valsartan medications – prescribed to control blood pressure – has led to previous recalls of numerous medications.

The recall was posted by the FDA as a Safety Alert: https://www.fda.gov/Safety/Recalls/ucm629213.htm

Our Investigation - Our Commitment

We are currently investigating serious injuries associated with the use of Valsartan. If you or a loved one suffered an acute liver injury or have been diagnosed with liver or other cancer after taking Valsartan for at least 30 days, we want to hear from you. Please complete and submit our Case Evaluation Form. We will contact you with 24 hours and if we agree to investigate your case further, we will begin working on it as soon as you formally hire us to do so. There is no out-of-pocket cost – we work strictly on a contingent fee basis which means we only receive a fee if you, or your loved one, receive compensation for the injury.

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CASE EVALUATION

Please fill in the form to request a FREE case evaluation from one of our attorneys if you or a loved one have taken Valsartan after January 1st of 2015 and subsequently been diagnosed with liver cancer, stomach cancer, intestinal cancer, colorectal cancer or kidney cancer (renal cancer).

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Have you or someone you know taken Valsartan after January 1st of 2015 and subsequently been diagnosed with liver cancer, stomach cancer, intestinal cancer, colorectal cancer or kidney cancer (renal cancer)? *
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