Blood Pressure Medications Containing Valsartan Found to Contain Cancer Causing Agents NDMA And NDEA
Over the last several months, the U.S. Food and Drug Administration (FDA) has issued a series of recalls for a number of valsartan medications. Valsartan is part of a class of medications known as angiotensin II receptor blockers (ARB), which are widely prescribed in the U.S. to treat hypertension (high blood pressure) and heart failure. In July of this year, the FDA announced it was recalling certain batches, or “lots”, of valsartan medications manufactured in China, as it had discovered that those lots were contaminated with the cancer-causing agent, NDMA (N-Nitrosodimethylamine). Consequently, and most devastatingly, thousands of U.S. citizens have been unknowingly exposed and affected for, potentially, the past several years.
Since July, the FDA’s recall has expanded to include dozens of additional lots of valsartan. The FDA’s continued investigation has further revealed that not only has valsartan been contaminated with NDMA, but some lots have been contaminated with another known carcinogen, NDEA (N-nitrosodiethylamne), a component used to make liquid rocket fuel. Even more, the contamination is no longer just limited to lots of valsartan, but other ARB medications containing irbesartan or losartan have since been recalled by the FDA.
Prior to the FDA’s recall, several pharmaceutical companies obtained the active ingredient needed to make their ARB medications from various international facilities, including those in China and India. While these manufacturing facilities have been cited by the FDA for violations like impurity control, change control, and cross-contamination, the root cause of the contamination is not yet known and remains under investigation. In the meantime, the FDA has put these facilities on import alert, thereby ceasing any further manufacturing of these ARB’s active ingredients, and blocking all finished drug products from entering the U.S. Additionally, as these recalls expand, U.S. pharmacies continue to send out warning letters to those patients who have had their blood pressure and heart failure prescriptions filled with drug products from the contaminated lots of valsartan, losartan, and irbesartan.
Contaminated ARB Medications May Lead to Digestive Tract Cancer
Exposure to one or more of the contaminated ARB medications (valsartan, losartan, and irbesartan) for more than thirty days has been reported to cause cancer. However, many people have potentially been exposed for much longer, due to lack of oversight and failure to recognize the impurities within the finished drug products sooner. Use of contaminated ARBs has been shown to cause cancer within the digestive tract, including:
- Stomach Cancer
- Kidney Cancer
- Liver Cancer
- Pancreatic Cancer
- Bladder Cancer
- Colorectal Cancer
The Number of Contaminated Lots Continues to Grow
Zhejiang Huahai Pharmaceuticals first reported the contamination in its facilities in July of 2018. Zhejiang had been contracted to make the active ingredients for several ARB distributors. As such, the FDA has recalled the ARB medications distributed by several different pharmaceutical companies, including:
- Aurobindo Pharma
- Mylan Pharmaceutical
- Prinston Pharmaceuticals
- Sandoz
- Solco Healthcare
- Teva Pharmaceuticals
A complete list of the losartan and valsartan medications that have been recalled by the FDA can be viewed at: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf, and the complete list of irbestartan medications that have been recalled can be viewed at: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM624627.pdf.
