Regulators in the USA have cleared the use of angiotensin receptor blockers almost a year after a meta-analysis was published in The Lancet Oncology that linked the high blood pressure drugs to an increased risk of cancer.
The US Food and Drug Administration began a safety review of ARBs last July after a meta-analysis found a small increased risk of cancer in patients taking the drugs. The vast bulk of the patients in the studies were taking Boehringer Ingelheim's Micardis (telmisartan) and the company vehemently rejected the claims.
The FDA is backing the German drugmaker's stance, having evaluated 31 clinical trials on more than 155,000 patients randomised to ARBs or other treatments. This was the largest evaluation of such data to date, says Mary Ross Southworth, deputy director for safety in the Division of Cardiovascular and Renal Drugs in the agency’s Center for Drug Evaluation and Research and it found "no evidence of an increased risk of cancer in patients who take an ARB".
As well as Micardis, other ARBs that were reviewed included AstraZeneca's Atacand (candesartan), Bristol-Myers Squibb/Sanofi's Avapro (irbesartan), Daiichi Sankyo's Benicar (olmesartan), Merck & Co's Cozaar (losartan) and Novartis' Diovan (valsartan), plus several combination drug products.
The FDA concluded by saying that "any concern about a relationship between ARB use and development of cancer has been resolved by this analysis".