valsartan cancer Lawsuit

Before diving into the details of valsartan and its potential side effects, it’s important to note that there are alternatives available for the treatment of high blood pressure. If you have been prescribed valsartan and have concerns about its safety, it is in your best interest to consult with your healthcare provider to explore alternative options that may better suit your needs. The following are some possible valsartan alternatives that may be effective in managing high blood pressure:

• Lifestyle modifications like adopting a healthy diet, regular exercise, limiting alcohol intake, and managing stress
• ACE inhibitor medications like enalapril and lisinopril
• Calcium channel blockers like amlodipine
• Beta-blockers like metoprolol
• Diuretics like hydrochlorothiazide

November 2019 – The FDA posts a warning letter to a Mylan Pharmaceuticals facility in India. According to the FDA, Mylan manufactures valsartan active pharmaceutical ingredient (API) and has been the subject of an ongoing investigation into nitrosamine impurities in ARB medications such as valsartan, losartan, and irbesartan. 

May 2019 – The FDA posts lab test results showing NDEA levels in recalled valsartan drug products, as well as an assessment of the cancer risk associated with the presence of NDEA in valsartan.

March 2019 – The FDA issues a press release warning the public about a recall of 87 lots of losartan potassium tablets manufactured by Hetero Labs Ltd. in India. “The recalled losartan potassium tablets […] contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), […] a known animal and potential human carcinogen,” the press release states. “This is the first ARB recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines.”

December 2018 – The FDA releases a warning letter issued to ZHP, “the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines.” According to the warning letter, there were “several manufacturing violations” at ZHP’s Chuannan facility, including “impurity control, change control and cross contamination from one manufacturing process line to another.”

October 2018 – The FDA posts lab test results showing NDMA and NDEA levels in recalled valsartan drug products. “Based on FDA laboratory testing results and records from manufacturers of the recalled valsartan lots, the impurities may have been present in valsartan-containing finished drug lots for up to four years,” the FDA warns. 

September 2018 – The FDA places Zhejiang Huahai Pharmaceuticals on import alert “to protect U.S. patients while the active pharmaceutical ingredient (API) manufacturer fully determines how impurities were introduced into its API and remediates its quality systems.”

August 2018 – In a statement about the FDA’s ongoing investigation into valsartan impurities and recalls, the FDA Commissioner and the director of the Center for Drug Evaluation and Research indicate that “We recently found that some generic versions of one medication, valsartan, contain an impurity that doesn’t meet FDA’s safety standards.” 

July 2018 – The U.S. Food and Drug Administration issues a press release alerting healthcare professionals and patients about a voluntary recall of several high blood pressure and heart failure medications containing the active ingredient valsartan. According to the FDA, the recall is due to “an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products.”

July 2010 – The FDA issues a drug safety communication alerting the public to an ongoing safety review of ARBs initiated after a published meta-analysis of 5 randomized clinical trials found a “small but statistically significant increase in the risk of cancer in patients taking an ARB compared to patients not taking an ARB.”