MedifocusHealth

Currently, in the United States, several medications are approved by the U.S. Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis and are considered as "first-line" medications. These medications include:

• Biphosphonates
• Raloxifene
• Nasal calcitonin
• Teriparatide

Biphosphonates

• Biphosphonates are a class of medications that are widely used for both the prevention and treatment of osteoporosis.

• Studies have shown that biphosphonates reduce the risk of vertebral and hip fractures by 50% to 60%.

• Examples of oral biphosphonates (taken by mouth as a pill) include:

  • alendronate (Fosamax)
  • risendronate (Actonel)
  • ibandronate (Boniva) - approved as a once-daily oral tablet with a recommended dosage of 2.5 mg ; also approved as a once-monthly oral tablet with a recommended dosage of 150 mg on the same day each month

• Side effects of oral biphosphonates may include:

  • injury to the esophagus
  • osteonecrosis of the jaw - destruction of bone cells in the jaws
  • severe musculoskeletal pain that may occur within days or months after starting a biphosphonate medication
  • eye inflammation

• Oral biphosphonates should be used cautiously in patients with gastroesophageal reflux disease (GERD) or dysphagia (difficulty swallowing) because they increase the risk of damage to the esophagus.

• Ibandronate (Boniva) is approved for administration by the intravenous (IV) route every 3 months. This avoids the gastrointestinal side effects that can occur with the oral biphosphonates.

• Zoledronic acid (Reclast) - approved as a once-a-year intravenous (IV) treatment for women with postmenopausal osteoporosis. For optimal efficacy in reducing the risk of osteoporosis-related fractures, zoledronic acid therapy should be supplemented with daily intake of calcium and vitamin D.

Biphosphonates and Atrial Fibrillation

Atrial fibrillation is a heart rhythm disorder involving the two upper chambers of the heart called the atria that is characterized by a rapid, abnormal heart rate. An article published in the May 3, 2007 issue of the New England Journal of Medicine reported increased rates of serious atrial fibrillation in two different studies of older women with osteoporosis treated with the biphosphonates Reclast and Fosamax. The authors of the article defined "serious" atrial fibrillation as either life-threatening, resulting in hospitalization, or causing disability. In both studies, more women who received one of the biphosphonates reportedly developed serious atrial fibrillation as compared to women who received placebo. In both studies, the rates of all atrial fibrillation (serious plus non-serious) were not significantly different between the groups treated with biphosphonates versus the placebo group.

Subsequent to the publication of this article in 2008, the U.S. Food and Drug Administration (FDA) issued an early communication of an ongoing safety review of a possible association between biphosphonates and the development of atrial fibrillation. Atrial fibrillation is a heart rhythm disorder common in individuals 65 years of age and older - the same age group of many of the patients studied in the New England Journal of Medicine article. Upon initial review, the FDA noted that it is currently unclear how these data on serious atrial fibrillation should be interpreted. Therefore, at the present time, the FDA does not recommend that health care providers or patients should change either their prescribing practices or their use of biphosphonates.