Product News and Recalls

Valsartan Contamination and Cancer: What are the Risks?

valsartan recalled over contamination cancer concernsRecent news stories regarding certain heart medications also came with a startling warning: patients taking medications using the ingredient valsartan may have been unknowingly ingesting chemicals that could be carcinogenic. The issue stems from contamination of valsartan batches with chemicals that are generally used in a wide variety of industrial applications from making rocket fuel to processing fish.

The chemical at the center of the story, NDMA or N-nitrosodimethylamine, was discovered when testing batches of valsartan for use in heart and blood pressure medications. And, according to a new story posted to CNN, the start of that that contamination could go as far back as 2012. It is especially troubling then that a recall for certain valsartan-based products was only issued by the FDA and other agencies around the world this past July.

Given the length of time that has elapsed and the fact that cancer has been mentioned as a possible consequence of the contamination, patients are obviously on edge and wondering exactly how much of a risk they have been exposed to.

A study was recently conducted on data from 5,150 Danish patients who had taken valsartan between 2012 and 2018. The patients were divided into two groups. One group had likely taken valsartan that was contaminated with NDMA and the other was not likely to have done so. The potential increase in cancer risk for the contaminated group was found to be a statistically-insignificant 9 percent.

The researchers caution that this was a short-term study conducted on a limited amount of data. This means that while the cancer risk posed by the contamination may not be immediate, the longer-term risks over years or decades remain unknown. And, the researchers had no way of knowing the exact amount of NDMA that may have been contained in each pill, or if the pill contained any NDMA at all. Putting it another way, the study was the best that could be accomplished under relatively rushed circumstances. However, the data set could be flawed and the controls for that data were a bit less than ideal.

So, while one of the first studies into the matter fails to go so far as to say that there isn’t a risk associated with the event, it also fails to show a spike or even a small uptick in the number of short-term cancer cases as a result of that event. Patients can breathe a little easier as a result, but should still maintain contact with their medical care providers to stay on top of any new information as it becomes available.