Over the summer, a prescription drug called valsartan was recalled. Valsartan is used to treat high blood pressure. It was discovered to be contaminated with N-nitrosodimethylamine (NDMA), which is a carcinogen. It was discovered that NDMA may have contaminated some valsartan batches since 2012. Since the recall, patients who used the drug were concerned with how much of a cancer risk the drug posed to them.
The FDA did an assessment of the risks of patients getting cancer from taking valsartan, and the results were recently published. Scientists with the FDA estimated that if 8,000 people took the highest valsartan dose at 320 milligrams from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of those 8,000 people.
The new study involved looking at health data on over 5,000 Danish patients who filled a valsartan prescription between 2012 and 2018. The researchers tracked each patient’s exposure to NDMA contamination based on the valsartan products they used. The researchers then compared cancer occurrence among the patients who had been exposed to NDMA contamination versus those who had not been exposed. Over an average of almost five years, exposure to valsartan products potentially contaminated with NDMA showed no association with overall cancer risk when compared with exposure to valsartan products that are unlikely to be contaminated.
However, the study only looked at the short-term cancer risks of being exposed to valsartan. More research is needed to explore long-term total cancer risk. Also, the NDMA content of each individual valsartan tablet was not included in the data since that information was not available.
Pharmaceutical companies have a duty to make products that are safe for consumption by their customers. If you believe that you have suffered harm because of a dangerous prescription drug, you should speak with an attorney.