FDA: No Increased Cancer Risk With ARBs



Treatment with angiotensin receptor blockers is not associated with an increased risk of cancer, according to a Food and Drug Administration meta-analysis that the agency called the largest ever to examine a possible association.

"Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer," the agency said in a drug safety communication issued June 2.

There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). They are also available in combination with hydrochlorothiazide and/or amlodipine; valsartan is also available in combination with aliskiren.

In July 2010, the FDA announced it would conduct a safety review of ARBs, after a meta-analysis of five randomized studies that included about 62,000 people found a small but statistically significant increase in the risk of cancer associated with the use of ARBs (Lancet Oncol. 2010:11;627-36).

The FDA subsequently conducted a meta-analysis of 31 studies including nearly 156,000 patients randomized to an ARB (84,461 patients) or a non-ARB comparator (71,355 patients) who were followed for an average of 3 years and 3 months.

That meta-analysis "found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs," the FDA statement said.

The meta-analysis involved studies that included more than 100 patients, that lasted for at least 1 year, and that included cancer or cancer deaths as a prespecified end point or adverse event.

The FDA statement referred to three recently published studies, which also did not suggest an increased risk of cancer associated with the use of an ARB.

Health professionals should report serious adverse events associated with ARBs to the MedWatch program at 800-332-1088 or

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