FDA calls 'all clear' on bone meds

Bone drugs Reclast [1] and Fosamax can step out from under a safety cloud, because the FDA came, saw and found nothing. The agency had been reviewing the two meds--sold by Novartis and Merck, respectively--for possible links to atrial fibrillation.

You'll recall that last year, the New England Journal of Medicine article fingered Reclast and Fosamax for an increased rate of serious atrial fibrillation in older women. The FDA took a quick look at the studies and found that one involving Reclast showed an increase in the heart rhythm problem. So the agency asked drugmakers for more data, and after checking it all out, now says it hasn't observed a link between bisphosphonates--the class of meds that includes Reclast and Fosamax--and atrial fibrillation.

FDA sifted through data on 19,687 patients treated with bisphosphonates and another 18,358 on placebo. Atrial fibrillation raised its head only a few times within each study, with most studies reporting two or fewer events.

Still, the FDA says it may call for additional studies, and it's continuing to monitor post-market reports. FYI, the bisphosphonate class also includes Boniva from Roche and GlaxoSmithKline, Actonel from P&G and Sanofi-Aventis, and the Novartis med Zometa [2].

- see the CNBC story [3]
- read the article [4] in the Wall Street Journal

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Safety questions on Fosamax, Actos, et al. [5]