FDA launches safety review of ARBs

After a recent study suggested that the angiotensin receptor blockers--including Novartis' Diovan and Merck's Cozaar--carry an increased risk of cancer, the FDA has decided to follow up on that research with a review of its own.

The agency says it's putting ARBs under a safety review, with plans to sift the available data and find ways "to better assess a possible link between use of ARBs and cancer." The FDA emphasizes that its review is ongoing and that it hasn't come to any conclusions yet. "At this time, FDA believes that the benefits of these medicines continue to outweigh their potential risks," the agency says in a statement.

The original study was a meta-analysis that combined cancer-related data from several clinical trials; researchers found "a small increased risk" of new cancers in patients who used ARBs. The studies weren't designed to assess the cancer risk of these drugs.

What's more, the ARB data mostly came from patients taking Boehringer-Ingelheim's Micardis, rather than a broad spectrum of drugs in that class. The FDA is planning to go back to the drawing board with the study data.

- get the FDA announcement
- see the coverage from Reuters