FDA continues to investigate the presence of impurities in valsartan products and other angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure. FDA recently identified the impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in certain valsartan products. FDA is posting its test results showing NDMA levels in recalled valsartan products. FDA will also post test results and an assessment of the cancer risk from NDEA when they are available.
The table below shows the NDMA test results for the recalled valsartan products. The analyses reflect average levels of NDMA present in a single tablet based on the strength of the tested drug product within the lots tested, which are identified in the table. Some of products listed below may have been repackaged by other companies as noted in FDA’s list of valsartan products under recall. For reference, consuming up to 0.096 micrograms of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure.
FDA previously estimated that if 8,000 people took the highest valsartan dose (320 mg) containing NDMA from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of the 8,000 people. That estimate was based on the highest daily dose, however many people may have taken lower doses, and therefore their risks would theoretically be less. FDA expects the actual cancer risk to most consumers to be lower than our estimate.
|Company||Product (tablets)||Lots Tested||NDMA level (micrograms -mcg/tablet)|
|Hetero Labs Ltd||Valsartan 320mg||VLS18049, VLS18051, VLS18050||0.3-0.4|
|Prinston Pharmaceutical||Valsartan 320mg/HCTZ 25mg||611B18025, 611B18026, 611B18027||13-20|
|Prinston Pharmaceutical||Valsartan 320mg||344B18027, 344B18028, 344B18029||15-16|
|Teva Pharmaceuticals||Valsartan 320mg||1240425A, 1247282M, 1263943A||8-17|
|Teva Pharmaceuticals||Valsartan 320mg/HCTZ 25mg||1217576M, 1217577M, 1217578M||7-10|
|Torrent Pharmaceuticals||Amlodipine 10mg/Valsartan 320 mg/HCTZ 25mg||BBX2E001, BBX2E002, BBX2E003||10-12|
|Torrent Pharmaceuticals||Amlodipine 10mg/Valsartan 320 mg||BV77E001, BV77E002, BV77E003||5-9|
|Torrent Pharmaceuticals||Valsartan 320mg||BV48D001, BV48D002||0.5-0.6|
(Source: The U.S. Food & Drug Administration)