The Food and Drug Administration (FDA) has recalled several types of blood pressure medication due to the class of drugs’ identification as a possible carcinogen.
These antihypertensive pills, particularly valsartan, losartan, and irbesartan, were found to contain N-Nitrosodiethylamine (NDEA) or N-Nitrosodimethylamine (NDMA) in some batches. These substances are connected to a risk of cancer in humans. In an FDA report on one of the recalls, the federal agency stated that NDEA and NDMA likely entered the pills “as a result of the manufacturing process.”
Many blood pressure medications are produced in foreign countries, specifically China and India. In these nations, manufacturing is not closely monitored — United States consumers are using drugs that were not produced under United States regulations. The FDA completes some of its own inspections of foreign drug manufacturers, however, investigators are not able to review the practices of foreign entities as closely as plants in the United States.
Currently, the number of people affected by the tainted pills is not known, and the potential ramifications of use have yet to arise. As of now, the only indicator of the dangerous drugs’ reach is the sales numbers. NBC News reported, “In 2016, 1.6 million people purchased valsartan and 9.2 million bought losartan, according to data provided by the U.S. Department of Health and Human Services.”
The true level of exposure to NDEA and NDMA is also blurry. Present estimates question if the amount of chemicals in the recalled medication will actually cause cancer, but it was described as “well beyond the risk that government agencies typically deem acceptable" by Lisa Lefferts of the Center for Science in the Public Interest.
This uncertainty is leaving patients in a state of limbo in relation to their medication. Some people in the medical field, along with the FDA, advised against ending use of the medication, saying stopping could pose greater harm than continuing use. Finding alternatives has been difficult as well, and the whole situation has patients and their doctors confused about what is safe.
Although the actual effects of the contamination are uncertain, legal action is emerging. The presence of carcinogenic substances in medication is indicative of a systemic pattern of negligence in the pharmaceutical industry.
If you were prescribed a blood pressure medication that was recalled, or were affected by another dangerous drug or medical device, contact Brett H. Oppenheimer, PLLC. Schedule a free consultation with our attorney by calling (502) 242-8877, or by completing our contact form.