A study of the risk of cancer of valsartan offers some "comfort" after recall

To date, the long-term risks posed by NDMA in certain drugs containing valsartan remain somewhat unknown, and the amount of NDMA consumed plays a role in this risk.

Valsartan is not patented and is used as a component of other generic drugs, but not all drugs containing the ingredient are involved in the recent recall.

A "not significant" increase in cancer risk

The new study included data on the health of 5,150 Danish patients who had completed a valsartan prescription between 2012 and 2018. The data came from four Danish national registries: the Danish Cancer Registry, the National Drug Registry, the patients and the civil registration system. .

The researchers tracked each patient's exposure to NDMA contamination based on the valsartan-based drugs they used, such as they appear in the National Prescription Registry. The researchers then compared the occurrence of cancer in patients who had been exposed to NDMA contamination compared to those who had not been exposed.

The researchers found that over an average period of 4.6 years, exposure to valsartan-based products potentially contaminated with NDMA showed no association with overall cancer risk compared with exposure to valsartan products unlikely to be contaminated.

When researchers analyzed associations with specific types of cancer, the risk of colorectal and uterine cancer was higher, but these risks were not statistically significant. The researchers remain uncertain about the possibility of a risk associated with certain types of cancer.

In general, "the estimate of our primary endpoint suggests a negligible and statistically insignificant increase in cancer risk by 9%," the researchers wrote in the study.

The study had some limitations, including the fact that the results only relate to the early cancer risk in the short term after exposure to NDMA, which means that more research is needed to explore the risk of cancer. total cancer in the long term. In addition, the actual NDMA content of each valsartan tablet was not included in the data as this information was not available.

"At most, our results suggest that the levels of NDMA exposure achieved with valsartan products do not result in a substantial increase in the risk of cancer in the short term. study assesses a potential security problem, "wrote the researchers in the study.

"I do not think it means that patients are completely out of the forest"

"This gives a modest assurance in the short term, but the absence of a signal for an excess of cancer is not so surprising to me because it is too early for something like cancer" said Michos. l & # 39; study.

"There was not enough follow-up to really see a signal, so although I'm reassured that I did not find one, I do not think it means that patients are completely out of the woods." , she said. , adding that she plans to inform her own patients of the new study.

"Now that this study is underway, I'm going to share it with my patients, I think a lot of them are worried, and although this data does not dispel all fears – it's not a long enough follow-up. – I think that will give them at least a short-term insurance, "she said. "Although this is of concern, the cancer risk attributable to this exposure, if any, should be very low."

In the editorial, they noted how the study was planned, conducted, analyzed and published within three months of the regulatory authorities' notification of the problem of contamination.

"This study alone can not dispel doubts about the potential risk to patients in the long run, but it helps to inform decision-making about this episode," Banzi and Bertele wrote.

"It also illustrates the utility of national registries in examining the relationships between risk factors and health problems and how research can provide a quick response when public health problems arise," they wrote.

Overall, Michos said that the fact that a contaminant was found in Valsartan at the start was "a violation of all our trust".

"Everyone is asking about safety and the public wants their medicine to be safe, so this incident raises questions about other products made in China and how they meet standards," said Michos.

"This contaminant started in 2012, so why did it take six years to find out?" she asked. "Public safety is our number one priority, so I do not shed light on that."

If you are concerned that your medicine may be on the recall list, consult your doctor or pharmacist before changing the medication with your medication. Since all valsartan medications are not involved in the recall, they may be able to offer you a version of the drug manufactured by another company.

If you know your medicine is on the recall list, the FDA suggests that you continue to take it until your doctor or pharmacist provides you with one.