About Osteoporosis

FDA has issued an early communication to healthcare professionals about a possible association between bisphosphonate drugs, which are used to treat osteoporosis, and atrial fibrillation. This issuance is part of FDA’s commitment to keep the public informed about ongoing safety reviews of drugs, even when the evidence isn’t conclusive. In this case, the communication is based on two studies of women treated with the bisphosphonates Reclast (zoledronic acid) and Fosamax (alendronate). They were reported in the May 3, 2007 issue of the New England Journal of Medicine. In both studies, more women who received the bisphosphonates developed serious atrial fibrillation than those who received placebos. There was no significant difference between the two groups in the rate of non-serious fibrillation. FDA has reviewed these studies, along with premarket studies and postmarketing reports on bisphosphonate drugs, and at this point, it is not clear how the data on serious atrial fibrillation should be interpreted. Because of this uncertainty, FDA is not recommending that healthcare providers or patients change the prescribing or use of these drugs at this time. FDA is gathering additional data that will allow for an in-depth evaluation of the atrial fibrillation issue for the entire class of bisphosphonates. As soon as the evaluation is finished, which may take up to 12 months, FDA will inform the public about the results and any new recommendations on prescribing or using these …

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