Cancer Reports Associated with 2018 Recalls of Angiotensin Receptor Blockers

Sudden, transient increases in cancer reports after recalls likely represent false cancer signals related to extensive media coverage.

In July 2018, several lots of the angiotensin receptor blocker (ARB) valsartan were recalled worldwide because the potential carcinogen N-nitrosodimethylamine (NDMA) was detected. Shortly thereafter, the same contaminant was found in losartan and irbesartan lots, prompting recalls of those ARBs. To understand the association between these ARB recalls and subsequent reports of cancer, investigators conducted a cross-sectional study using the FDA Adverse Event Reporting System database.

After the July 2018 valsartan recall, the number of valsartan-associated cancer reports suddenly and transiently increased (in July and August). Compared with negative controls (amoxicillin and sertraline, neither associated with cancer), odds of cancer reports…

Reviewing Author

Karol E. Watson, MD, PhD, FACC

Disclosures

Consultant/Advisory BoardBoehringer Ingelheim; Amgen; Novartis; Lilly; Amarin

Speaker’s BureauBoehringer Ingelheim

Grant/Research SupportNIH

Editorial BoardsCirculation (Associate Editor)