One year after an analysis of five studies involving some 60,000 patients found links between angiotensin receptor blockers and an increased risk of cancer, the FDA has now decided that these meds - which are used to control high blood pressure, do not pose such a risk.
The study, which was published in The Lancet Oncology and prompted the FDA review, found that 7.2 percent of patients on an ARB were diagnosed with cancer compared with 6 percent on a placebo, which was deemed statistically significant. Put another way: one extra cancer case would occur for every 105 people taking the meds for about four years (back story).
Most of the patients were taking Boehringer Ingelheim’s Micardis, a $1.5 billion seller, prompting an angry rebuttal from the drugmaker. Other ARBs that were studied included Merck’s Cozaar, which is now generic; Novartis’ Diovan; Avapro, which is sold by Bristol-Myers Squibb and Sanofi-Aventis; and Daiichi Sankyo’s Benicar.
In reaching its decision, the FDA says it evaluated 31 randomized clinical trials that compared patients taking an ARB to patients not taking an ARB. This amounted to reviewing more than 155,000 patients, which the agency called the "largest evaluation of such data to date." Here is the FDA statement.