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FDA Date: 6/1/11
FDA Drug Safety Communication for Angiotensin Receptor Blockers
No Increase in Risk of Cancer With Certain Blood Pressure Drugs--Angiotensin Receptor Blockers (ARBs)
FDA has completed a review of the potential risk of cancer associated with the class of medications known as angiotensin receptor blockers (ARBs). FDA has concluded that treatment with an ARB medication does not increase a patient's risk of developing cancer.
In July 2010, FDA communicated its intent to conduct a safety review of ARBs after a published meta-analysis of 5 randomized clinical trials reported a small but statistically significant increase in risk of cancer in patients taking an ARB compared twith 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, far more than the approximately 62,000 in the published analysis. FDA's more comprehensive meta analysis did not show an increased risk of cancer in the patients taking an ARB medication.
Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer.