Valsartan Recalls – Contamination with Potential Carcinogen

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In July 2018, the US Food and Drug Administration announced a voluntary recall of generic valsartan products manufactured by a Chinese company and marketed in the US by several distributors.  The impurity, N-nitrosodimethylamine (NDMA), a suspected carcinogen, was found in batches of valsartan products and it is suspected that the impurity may have been present in supplies from this manufacturer for several years.  In September, a similar impurity, N-nitrosodiethylamine (NDEA), was also found in valsartan from this same Chinese manufacturer.  NDEA is also a suspected carcinogen.

Over the past several months, several updates have been issued by the FDA including lists of specific products that are and are not included in the recall.  A link to a full summary of all FDA alerts is provided below.

On September 13, 2018, BMJ published a study from Denmark conducted using Danish registry data showing no increased risk of cancer in over 5,000 patients who had been taking the contaminated valsartan product over a 6-year period.  Over a 4.6 year follow-up period, there were 104 new cancer diagnoses among NDMA-unexposed patients and 198 among NDMA-exposed patients.  After adjusting for known determinants of cancer, there was no increased risk for cancer in patients attributable to the use of contaminated valsartan products.

Additional information about valsartan can be found in the Top 300 Pharmacy Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Top 300 Pharmacy Drug Cards.  If your institution does not provide access, ask your medical librarian about subscribing.

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More Information...

For a summary of FDA notices regarding the recalls, click here.

Click here for access to BMJ article:  Pottegård A, Kristensen KB, Ernst MT, Johansen NB, Quartarolo P, Hallas J.  Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study.  BMJ 2018;362:k3851. doi: https://doi.org/10.1136/bmj.k3851


Go to the profile of Jill Kolesar & Lee Vermeulen

Jill Kolesar & Lee Vermeulen

Professors, University of Kentucky

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