Posted by on June 4, 2010 - 3:02pm

A recent publication from the National Osteoporosis Foundation reported that many women with postmenopausal osteoporosis underestimate their risk for fractures.  This is particularly alarming when it is coupled with new information released from the Food and Drug Administration (FDA) that found potential increased risk of fracture of the hip, wrist and spine if you take certain drugs for heartburn, acid reflux, or ulcers.

The drugs under study belong to a class of medications called proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach.   They are available as prescriptions and as over-the-counter medications.  These drugs treat conditions like gastroesophageal reflux disease (GERD),  heartburn and ulcers of the stomach and small intestines.

Prescription PPIs include:    Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex and Vimovo. The over-the-counter PPIs are:   Prilosec OTC and Zegerid OTC (omeprazole), and Prevacid 24R (lansoprazole).

According to the FDA, consumers should:

  • NOT stop taking your PPI unless told to by your health professionals.  They are an effective treatment for many GI disorders.
  • Be aware that an increased risk of fractures of the hip, wrist, and spine have been reported in some studies with the greatest increased risk for these fractures among those who receive high doses of these medications or use them for a year or longer.
  • Read labels and follow instructions carefully and talk to your health provider if you have questions.
  • Be aware that the over-the-counter PPIs should only be used as directed for 14 days for the treatment of frequent heartburn.   If your heartburn persists, talk to your health professional.   No more than three 14-day treatment courses should be used per year.
  • Report any side effects from the use of PPIs to the FDA MedWatch Adverse Reporting Program.

To read the full FDA article click here.  Osteoporosis affects 8 million women and 2 million men in the U.S.

Posted by on March 11, 2010 - 10:23am

The FDA recently issued the following communication report:     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.

Based on published case reports of atypical subtrochanteric femur fractures occurring in women with osteoporosis using bisphosphonates, FDA, in June 2008, requested information from all bisphosphonate drug manufacturers regarding this potential safety signal. All available case reports and clinical trial data were requested. FDA's review of these data did not show an increase in this risk in women using these medications.
In addition, FDA reviewed a December 2008 article in the Journal of Bone and Mineral Research by Abrahamsen et al1, that analyzed data from two large observational studies in patients with osteoporosis. The authors concluded that atypical subtrochanteric femur fractures had many similar features in common with classical osteoporotic hip fractures, including patient age, gender, and trauma mechanism. The data showed that patients taking bisphosphonates and those not taking bisphosphonates had similar numbers of atypical subtrochanteric femur fractures relative to classical osteoporotic hip fractures.

The FDA will continue to review new information as it becomes available and will update the public once the agency's review is complete.

Healthcare professionals should continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should not stop taking their medication unless told to do so by their healthcare professional. Patients should talk to their healthcare professional about any concerns they have with these medications.

Additional Information for Patients

If you currently take an oral bisphosphonate you should:

* Not stop taking your medication unless told to do so by your healthcare professional.
* Talk to your healthcare professional if you develop new hip or thigh pain or have any concerns with your medications.
* Report any side effects with your bisphosphonate medication to FDA's MedWatch program.

Additional Information for Healthcare Professionals

FDA recommends that healthcare professionals should:

* Be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.
* Continue to follow the recommendations in the drug label when prescribing oral bisphosphonates.
* Discuss with patients the known benefits and potential risks with using oral bisphosphonates.
* Report any adverse events with the use of oral bisphosphonates to FDA's MedWatch program.


1. Abrahamsen B., Eiken P., Eastell R. Subtrochanteric and Diaphyseal Femur Fractures in Patients Treated With Alendronate: A Register-Based National Cohort Study. J Bone Miner Res. 2009 Jun;24(6):1095-102.