On 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.
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:
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 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:
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
On December 31, 2018, Aurobindo Pharma USA, Inc. announced a recall of 80 lots of its valsartan drug marketed under the names:
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
We are currently investigating serious injuries associated with the use of Valsartan. If you or a loved one have been diagnosed with stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer, liver cancer, prostate cancer, pancreatic cancer, leukemia, non-Hodgkin’s lymphoma, or multiple myeloma after January 1st of 2017, 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.