FDA MedWatch- Bisphosphonates-Update To The Early Communication Issued Regarding Atrial Fibrillation With Bisphosphonates

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Wed, 12 Nov 2008 11:50:24 -0600 (CST)

Title: FDA MedWatch- Bisphosphonates-Update To The Early Communication Issued Regarding Atrial Fibrillation With Bisphosphonates

	Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D)

Etidronate (Didronel)

Ibandronate (Boniva)

Pamidronate (Aredia)

Risedronate (Actonel, Actonel W/Calcium)

Tiludronate (Skelid)

Zoledronic acid (Reclast, Zometa)

Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals 

FDA issued an update about the Agency's review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Update of Safety Review Follow-up to the October 1, 2007, Early Communication about the Ongoing Safety Review of Bisphosphonates, regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#bisphosphonates2

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