SAFETY ALERT: FDA Reports No Increased Risk of Cancer with Angiotensin Receptor Blockers

The FDA announced that it has determined that angiotensin receptor blockers (ARBs) do not increase the risk of developing cancer in patients using the medications. In July 2010, the FDA reported that a safety review of ARBs would be performed after a published meta-analysis of five randomized clinical trials that included 62,000 patients reported a small but statistically significant increase in risk of cancer in patients taking an ARB compared to patients not taking an ARB. To further evaluate the reported link between use of ARBs and cancer, FDA conducted a trial-level meta-analysis of clinical trials in which patients had been randomized to an ARB treatment or a non-ARB treatment. This analysis included 31 trials and approximately 156,000 patients. Based on the review and analysis of all currently available data regarding this potential safety signal, the FDA has concluded that treatment with an ARB medication does not increase the risk of cancer.

This class of medication includes Atacand (candesartan cilexetil; AstraZeneca), Avapro (irbesartan; Bristol-Myers Squibb), Benicar (olmesartan medoxomil; Daiichi Sankyo), Cozaar (losartan potassium; Merck), Diovan (valsartan; Novartis), Micardis (telmisartan; Boehringer Ingelheim), and Teveten (eprosartan; Abbott).

For more information visit www.fda.gov/Drugs/DrugSafety/ucm257516.htm.