FDA Safety Review on Fosamax and Other Bisphosphonates

Safety Review on Bisphosphonates including Fosamax and Fosamax Plus D

Below is a list of osteoporosis drugs, common drug treatment for osteoporosis. These drugs do not prevent osteoporosis and in my opinion are not the best treatment for osteoporosis.

According to this information from the FDA released March 2008 these warnings affect all bisphosphonate drugs, commonly used for osteoporosis treatment: Fosamax, Fossamax Plus D, Didronel, Boniva, Aredia, Actonel, Actonel W/Calcium, Skelid, Reclast, Zometa.*

“Publications in a recent issue of The New England Journal of Medicine have raised the question about the association of atrial fibrillation with the use of bisphosphonates.

“FDA has reviewed some safety data and requested additional data to further evaluate the risk of atrial fibrillation in patients who take bisphosphonates.

“An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine describe increased rates of serious atrial fibrillation (defined by the authors as life-threatening or resulting in hospitalization or disability) in two different studies of older women with osteoporosis treated with the bisphosponates, Reclast and Fosamax. In both studies, more women who received one of the bisphosponates (Reclast-1.3% or Fosamax-1.5%) reportedly developed serious atrial fibrillation as compared to women who received placebo (Reclast study-0.5%, Fosamax study-1.0%). In both studies, the rates of all atrial fibrillation (serious plus nonserious) were not significantly different between groups treated with bisphosphonate versus placebo.”

“What does FDA know about this concern?”

“The FDA reviewed spontaneous post-marketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosponate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, the FDA evaluated the possible association between atrial fibrillation and the use of Reclast. Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.”

“Atrial fibrillation is a heart rhythm disorder common in individuals 65 years old and older, the same age range of many of the patients studied in the article published in The New England Journal of Medicine. Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.”

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Bisphosponates are risky and can be dangerous, and there is no guarantee these treatments can help improve your bone density dexa scores. There are better, more natural osteoporosis treatments available, learn more right here at Bone Density Blog.

* These names are registered trademarks of the manufacturers. Alendronate (Fosamax®, Fosamax Plus D® Fosamax, Fossamax Plus D, Didronel, Boniva, Aredia, Actonel, Actonel W/Calcium, Skelid, Reclast, Zometa.