According to CNN, the U.S. Food and Drug Administration has been investigating a class of drugs known as angiotensin II receptor blockers, which are prescribed to people with high blood pressure. It’s believed that these drugs contain contaminants that are associated with increased cancer risk, and it’s believed that even more tainted medications will be found during the course of the investigation. While initial reports began in 2010, the FDA failed to initiate its recall until July of last year.
Chemical reactions during the manufacturing process are thought to be the cause behind the contamination. These chemical reactions led to the presence of N-nitrosodimethylamine (NDMA) in the medications. This substance, which is commonly used to make rocket fuel, is a possible cancer-causing agent due to its effect on DNA replication. The chemical reaction could have been caused by the re-use of certain materials, but the exact cause is not known.
The drugs were imported by a Chinese manufacturer, Zhejiang Huahai Pharmaceuticals. While the FDA does test drugs distributed in the U.S., they were unaware that a chemical reaction could cause NDMA to be present in medications. As a result, tests were not conducted to identify its presence, which led to the contaminated drugs being widely distributed.
While the risk of cancer developing is deemed quite low, millions of people have been prescribed these possibly contaminated drugs. This low likelihood will be of little comfort to those who are impacted, especially when considering the FDA’s role in protecting people from occurrences like this. Some people are calling for more inspections of foreign drug manufacturers, as well as increased oversight for the drugs coming into this country.