FREE VALSARTAN CASE REVIEW

Not all valsartan manufacturers were included in the recall, as levels of NDMA varied (likely due to different production techniques). The products included in the recall are: 

A complete list of individual products, including lot numbers and expiration dates, is available from the FDA. Over the years, many patients have likely discarded their prescription bottles, making it difficult to determine whether the product they used may have been affected by the recall. It may be helpful to contact your pharmacy to request documentation of these fill records – in some instances, these records may still be retrievable. 

Nitrosamines such as NDMA have been shown to damage DNA and cause mutations. These effects can lead to the development of certain cancers, with a notable association with pancreatic cancer and colorectal cancer. 

In February 2019, the FDA established acceptable levels of nitrosamines based on a risk level of one additional cancer case for every 100,000 patients exposed continuously for 70 years. For context, the levels of NDMA found in some valsartan products were estimated to cause cancer in one out of every 8,000 people exposed for four years (the amount of time the affected products were on the market). 

Cancer is not an immediate effect. The potential delay of several years prior to a diagnosis can introduce potential difficulty in identifying associations. Estimates of use are not precise, but it is likely that several million people took the affected valsartan products. Considering risk estimates and the number of people who used the affected products, it is likely that there have been a significant number of relevant cancer diagnoses appearing in recent years. 

While some studies have explored the short-term disruption of cardiovascular care caused by valsartan recalls, it is important not to discount the potential increases in cancer diagnoses. These diagnoses have a potentially immense impact on individuals' physical, emotional, and financial health. 

Studies on valsartan-related cancer diagnoses in the years after the recall are somewhat limited. One article published in Circulation shows a rapid, transient increase in associated cancer diagnoses in the first year after the recall, citing the potential effects of extensive media coverage. It could also be argued that any potential increase in screenings and identification of cancers was ultimately a positive population effect, however. 

A Danish cohort study explored the potential effects of valsartan on various cancer diagnoses. While results were ultimately inconclusive, several limitations were present, including a small sample size and a very short follow-up period. Potentially higher rates of colorectal and uterine cancers were noted. 

A German cohort study with a larger sample size and longer follow-up period also explored the association between valsartan use and cancer diagnoses. This study revealed a higher risk of liver cancer. Overall, further studies would be beneficial to provide a more clear picture of the specific effects of valsartan during this time frame, and cancer risks remain a viable concern. 

If you took valsartan and have concerns related to your own health, it is best to discuss these with your doctor. Keeping regular appointments and reporting any changes in how you feel is important, particularly if you are experiencing any of the following:

Valsartan was recalled in 2018 due to contamination with nitrosamines like NDMA. These impurities were likely present dating back to 2012, and many patients may have used these products for years during this time frame, increasing the risks of liver damage and cancer. The FDA has taken these impurities and their resulting effects on public health seriously, and steps are being taken by manufacturers to prevent these kinds of exposures in the future. 

If you or a loved one used valsartan during the period of time the medication contained these impurities, it is best to discuss this with your doctor and continue to monitor and report any concerning changes in how you are feeling.