FDA Safety Announcement About Bisphosphonates

Most readers who visit my blog have either already stopped taking bisphosphonates for osteoporosis or are seriously contemplating doing so and switching to strontium or something else. ABC News has recently reported on femur fractures occurring in some patients following several years on bisphosphonates. In response to those news reports and the outcry from viewers, on 03/10/2010, the FDA issued a Drug Safety Communication on bisphosphonates and femur fractures. Here is part of that announcement:

"Patients and healthcare professionals may have questions about oral bisphosphonate medications and atypical subtrochanteric femur fractures – fractures in the bone just below the hip joint. Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis in postmenopausal women. Common brand names of medications in this class include Fosamax, Actonel, Boniva, and Reclast."

"Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these medications. At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue." See the entire FDA announcement at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

Report any adverse events with the use of oral bisphosphonates to FDA's MedWatch program:

1-800-332-1088
1-800-FDA-0178 Fax
MedWatch Online2
Regular Mail: Use postage-paid FDA Form 35003
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787