Despite lack of in-depth review, FDA says bisphosphonate use should continue
Agency unclear on how to interpret serious atrial fibrillation data
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On October 1, 2007, the United States Food and Drug Administration (FDA) released its conclusion from an initial review of bisphosphonate drugs. Despite a New England Journal of Medicine article published on May 3, 2007 that raised safety concerns about the drugs, the FDA said doctors and patients should continue their use of the drugs.
The May 2007 article questioned the association of atrial fibrillation, a heart rhythm disorder, with bisphosphonate drugs, which are used primarily to increase bone mass and reduce risks of fracture in osteoporosis patients.
Bisphosphonate drugs include:
The FDA reviewed reports of this association, but did not identify a class of patients who are at an increased risk of developing the heart rhythm disorder. The agency found most cases of atrial fibrillation occurred more than one month after the administration of the drug.
The FDA said it is unclear how to interpret the data on serious atrial fibrillation associated with the drugs. The FDA added it does not believe doctors or patients should change prescribing practices or the use of bisphosphonates. The agency is, however, seeking additional data to perform an in-depth evaluation of the safety issue for the entire class of bisphosphonates.
Source: “Early communication of ongoing safety review,” United States Food and Drug Administration Press Release, October 1, 2007.
