Massive Recall of Blood Pressure Drugs Due to -Causing Contamination: What You Really Need to Know
A headline claiming that blood-pressure medications have been recalled because of cancer-causing contamination can be frightening, particularly if you or someone in your family takes blood-pressure medicine every day.
The headline is based on a real medication-safety issue, but it is easy to misunderstand what actually happened.
The important point is this:
Certain batches of certain blood-pressure medicines were recalled because they contained unacceptable levels of nitrosamine impurities. This does not mean that all blood-pressure medicines are contaminated, and it does not mean that everyone taking one of these medications is in danger.
The issue primarily involved a group of medicines called angiotensin II receptor blockers, commonly known as ARBs or “sartans.” Certain products containing valsartan, losartan, and irbesartan were among those affected.
The recalls began after regulators discovered impurities such as NDMA and NDEA in some products.
These substances are considered potential or probable carcinogens, which is why the affected products were taken seriously.
But there is an important distinction between a medication being contaminated in certain batches and the medication itself being a cancer-causing drug.
Those are not the same thing.
What Are Nitrosamines?
Nitrosamines are a group of chemical compounds that can occur in the environment and can also be formed during certain industrial and manufacturing processes.
Some nitrosamines have been associated with cancer in laboratory studies, and several are considered probable human carcinogens.
The compounds that received particular attention during the blood-pressure medication recalls included:
NDMA — N-nitrosodimethylamine
NDEA — N-nitrosodiethylamine
NMBA — N-nitroso-N-methyl-4-aminobutyric acid
The concern was not that these substances were intentionally added to the medicines.
They were unexpected impurities.
In certain manufacturing processes, chemical reactions could create these unwanted compounds.
That discovery led regulators to investigate how the impurities were being produced and how they could be prevented.
