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FDA Drug Safety Podcast for Healthcare Professionals: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs)

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Welcome, my name is Catherine Chew, a pharmacist in the Division of Drug Information.  On June 2, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying the public it has completed a review of the potential risk of cancer associated with the class of medications known as angiotensin receptor blockers, also known as 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 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, 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.

At this time, FDA recommends that Healthcare Professionals:

  1. Know that FDA’s meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident, or new cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs.
  2. Report adverse events involving ARB medications to the MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  Please read the Drug Safety Communication for a list of FDA approved ARBs and background information detailing this communication.  A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety.   If you have drug questions, you can reach us at druginfo@fda.hhs.gov.


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