FDA: Blood Pressure Drugs Don't Pose Cancer Threat

U.S. health officials said on Thursday that a class of widely used blood pressure drugs does not increase the risk of cancer.

Last year, a published study reported a small increase in the cancer risk for patients taking medicines called angiotensin receptor blockers (ARBs), and the Food and Drug Administration launched its own yearlong safety review.

ARBs are used to treat high blood pressure and other heart-related conditions, and include Novartis's Diovan, Merck's Cozaar, and Avapro from Bristol-Myers Squibb and Sanofi.

"The FDA has completed its review of controlled trial data on more than 155,000 patients randomized to ARBs or other treatments — the largest evaluation of such data to date — and finds no evidence of an increased risk of cancer in patients who take an ARB," said Mary Ross Southworth, a deputy director for safety in the FDA's Division of Cardiovascular and Renal Drugs.

The FDA's conclusion may provide some relief to the big-name makers of ARBs, though they face a larger threat from generic rivals already beginning to flood the market.

A study published in June 2010 in the Lancet medical journal looked at data from more than 1,000 patients in several long-term clinical trials and found that the rate of new cancer cases was 7.2 percent for patients who took an ARB versus 6 percent for patients who did not.

An earlier analysis of data from several clinical trials showed patients who took ARBs were 1.2 percent more likely to be diagnosed with a new cancer over four years than those who did not.

In its study, the FDA evaluated 31 randomized clinical trials and said its analysis resolved all concerns about the relationship between ARBs and cancer.

ARBs work by blocking receptors for angiotensin II, a hormone that raises blood pressure. Sustained high blood pressure increases the risk of death, heart attacks, stroke, heart failure, and kidney failure.