FDA to Look Into Possible Cancer Risk With ARBs


July 16, 2010

July 16, 2010 (Bethesda, Maryland) — The US FDA has become the latest regulatory agency to say it will investigate a possible link between angiotensin-receptor blockers (ARBs) and cancer, in a safety alert for human medical products issued yesterday [1]. The move follows a meta-analysis reported in Lancet Oncology last month, which found a modest, but significant, increased risk of primarily lung cancer associated with the use of these antihypertensive agents.

The week after this paper was published, the European Medicines Agency (EMA) announced it would review the possible risk of cancer in patients taking ARBs, based on this. But many hypertension doctors are unhappy about the meta-analysis, citing many flaws, as reported by heartwire ; they also fear it will stop patients from taking their much-needed medication.

In its safety alert, the FDA says it has "not concluded that ARBs increase the risk of cancer. The agency is reviewing information related to this safety concern and will update the public when additional information is available. FDA believes the benefits of ARBs continue to outweigh their potential risks."