In light of concerns raised recently in the media about certain kinds of blood pressure drugs called angiotensin receptor blockers, or ARBs, the FDA is advising patients they should not stop taking their ARB medicine without first talking to their healthcare professional. Untreated high blood pressure can cause stroke, heart attack, heart failure, kidney damage, and other health problems.
About one in three adults in the United States has high blood pressure, a serious condition that can lead to heart and kidney disease and other health problems. ARBs, which are widely used to treat high blood pressure, as well as other blood pressure medicines, can help to control blood pressure in order to help avoid these problems. Brand names of ARBs include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten. A list of medications containing an ARB is available here.
In 2010, FDA conducted a safety review of ARBs after a published meta-analysis, an analysis of several separate studies, reported a small but statistically significant increase in risk of cancer in patients taking an ARB compared to patients not taking an ARB. In July 2011, FDA released a Drug Safety Communication concluding the evidence did not establish that treatment with ARBs increases a patient’s risk of developing cancer. As part of our post-market drug safety review process, FDA will continue to monitor ARBs for emerging safety issues.
With respect to recent media coverage describing disagreements among some FDA staff regarding the safety of ARBs, FDA notes that we encourage robust scientific discussions among our staff and outside experts on a wide range of public health matters, including drug safety. We have internal processes in place to ensure that final decisions are made after all appropriate expertise is brought to bear. When there is disagreement among FDA staff regarding scientific or regulatory issues, we have processes in place to resolve differing scientific opinions.
Two prior Drug Safety Communications:
July 11, 2011: FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs)
The previous "early communication" DSC was from July 2010.
FDA Drug Safety Communication: Ongoing safety review of the angiotensin receptor blockers and cancer