Hundreds of products containing Valsartan, a popular drug for treating high blood pressure and heart failure, have been recalled in more than 20 countries due to impurities in the medications that are linked to cancer and other serious medical problems. The recalled Valsartan pills were manufactured overseas in China and India, and the unexpected contamination with carcinogenic impurities is believed to be due to changes a major Chinese manufacturer made to the way the drug was made. According to reports, these manufacturing changes were made as far back as 2012, which means the recalled Valsartan-containing products may have contained these impurities for years. If you or a loved one has developed stomach cancer, colorectal cancer, pancreatic cancer, liver failure or another serious medical issue while taking contaminated Valsartan, contact an experienced Valsartan injury lawyer as soon as possible to discuss the possibility of pursuing compensation through a product liability lawsuit.
Valsartan is the generic component of prescription medications commonly used to treat high blood pressure and heart failure, and the drug is also sometimes prescribed to patients who have suffered a heart attack or who have type II diabetes, to slow the progression of kidney disease. Valsartan is the generic form of the brand-name drug Diovan and since 2012, Valsartan has been manufactured almost exclusively by the drug company Zhejiang Huahai Pharmaceutical Co. (ZHP) of China, which sold $50 million worth of Valsartan in 2017 alone. Valsartan belongs to a class of drugs known as angiotensin II receptor blockers (ARB), which work by inhibiting the action of the hormone that causes blood vessels to constrict, thereby lowering blood pressure.
Serious and potentially life-threatening side effects that have been linked to the cancer-causing impurities found in Valsartan and other contaminated blood pressure medications include:
The contamination of Valsartan pills with cancer-causing chemicals was first discovered in 2018, and the finding led to a recall of generic Valsartan manufactured in China and India and sold worldwide. In July 2018, the FDA announced a recall of hundreds of products containing Valsartan made in China or India and sold in the United States, but only after 22 other countries issued recalls affecting 2,300 batches of Valsartan. The first chemical impurity found in the Valsartan pills was N-nitrosodimethylamine (NDMA), a chemical the EPA has categorized as a “probable human carcinogen,” but when the FDA ran additional tests on batches of Valsartan contaminated with NDMA, the agency found that some of the drugs contained a second carcinogen, called N-nitrosodiethylamine (NDEA), a chemical that is “reasonably anticipated” to cause cancer in humans.
According to reports, the contamination of the Valsartan pills is believed to date back to 2012, when Novartis’ patent for Diovan/Valsartan expired and generic manufacturers were permitted to enter the lucrative Valsartan market. Eventually, drug companies began outsourcing the Valsartan manufacturing process to China and India in order to cut costs, and ZHP of China changed the way Valsartan was manufactured. As a result of these changes, the carcinogens NDMA and NDEA were produced as byproducts of the chemical reaction that creates Valsartan, and because these contaminants are a product of the Valsartan manufacturing process, it has become clear that a large percentage of the Valsartan sold worldwide may have contained these carcinogenic impurities for years.
Additionally, the ARB medications Losartan (Cozarr), Irbesartan (Avapro), Candesartan (Atacand) and Olmesartan (Benicar) undergo a chemical reaction during the manufacturing process that is similar to the reaction required to make Valsartan, which means it is possible these drugs may also contain carcinogenic impurities. In fact, trace amounts of NDMA and other potentially cancer-causing impurities have been found in other generic ARB medications, including generic Losartan, and since July 2018, the FDA has issued several recalls for Valsartan, Losartan and Irbesartan. In February 2019, the FDA announced that yet another potentially carcinogenic impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), was found in the popular blood pressure medication Losartan.
The Valsartan litigation is still relatively new and product liability lawyers are currently investigating and filing claims on behalf of individuals across the country who took Valsartan and other similar medications, like Losartan and Irbesartan. Patients who purchased contaminated Valsartan products may be entitled to compensation for the defective medications, and patients who developed cancer or required hospitalization due to liver damage or other related medical problems may also have grounds to file lawsuits for damages. Generally speaking, these Valsartan lawsuits may seek compensation for the following:
In February 2019, the U.S. Judicial Panel on Multidistrict Litigation (JPML) announced its decision to consolidate all Valsartan cases in the District of New Jersey, before Judge Robert B. Kugler.
July 2018 – European countries begin recalling contaminated Valsartan products after certain batches of the drug were found to contain NDMA.
July 2018 – The FDA issues a nationwide recall of Valsartan after finding the cancer-causing impurity NDMA in drug products containing Valsartan.
August 2018 – The FDA includes hundreds of U.S. drug products in the Valsartan recall.
August 2018 –Hetero Labs Limited of India, which used a manufacturing process similar to ZHP of China’s, is named as an additional source of the Valsartan contamination.
September 2018 – A second carcinogen (NDEA) is found in the recalled Valsartan products.
September 2018 – The European Medicines Agency (EMA) announces that it will review four other medications related to Valsartan (Irbesartan, Losartan, Candesartan and Olmesartan).
September 2018 – The FDA bans ZHP of China from importing Valsartan or any other medications into the United States after an inspection of ZHP of China facilities uncovered numerous violations.
October 2018 – The FDA announces an additional recall of certain batches of Irbesartan, a similar, non-Valsartan drug also used to treat high blood pressure.
December 2018 – The FDA announces a recall of Losartan after finding nitrosamines in the medication.
February 2019 – Another cancer-causing impurity, NMBA, is found in Losartan.
July 2017 – The authors of a Chinese study note that “Nitrosamines such as N-Nitrosodimethylamine (NDMA) in drinking water have recently attracted great attention because of their high carcinogenicity and high detection rate.”
September 2018 – A Danish nationwide cohort study indicates that exposure to NDMA can cause cancer of the liver, colon, pancreas, stomach and rectum.
January 2019 – The Open Access Macedonian Journal of Medical Sciences publishes a study highlighting the potential for irbesartan treatment to cause melanoma in users.
April 2019 – A study published in the Biological & Pharmaceutical Bulletin indicates that NDMA is believed to have been introduced into valsartan drug products due to the process by which the active pharmaceutical ingredient is manufactured.
April 2019 – Research conducted by MD Anderson Cancer Center notes “significant positive associations of NDEA and NDMA with a risk of pancreatic cancer.”
Patients who took contaminated Valsartan pills are now filing lawsuits against the drug companies and pharmacies who made and sold the defective medications. Plaintiffs in the Valsartan lawsuits are seeking compensatory damages for their injuries and pain and suffering, in addition to punitive damages to punish the drug manufacturers, distributors and retailers for negligently selling dangerous drugs containing cancer-causing chemicals. Valsartan lawsuits allege that:
Exposure to toxic chemicals found in recalled Valsartan products could increase patients’ risk of developing cancer of the liver, kidney, colon, stomach or gastrointestinal tract, among other serious illnesses, and if you have been exposed to contaminated Valsartan, you should discuss your treatment with your doctor right away. If you developed cancer or suffered liver damage while taking Valsartan or another angiotensin II receptor blocker, you should contact a knowledgeable Valsartan injury lawyer to discuss your legal options. You may have grounds to file a Valsartan lawsuit against the company that manufactured, promoted, marketed and sold the contaminated medication, and our consumer advocates at the Consumer Justice Foundation can help. We are committed to protecting the rights of innocent consumers harmed by defective and dangerous medications, and we can help put you in touch with an experienced Valsartan attorney.