* Warning * October 13, 2010, the U.S. Food and Drug Administration (FDA) reported that it is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels approved to treat osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast (and their generic products). A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription. BACKGROUND: Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates. RECOMMENDATIONS: Patients should continue to take their medication unless told to stop by their healthcare professional. FDA recommends that healthcare professionals should discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture. See the FDA Drug Safety Communication below for additional information. * Safety Alert * Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors The U.S. Food and Drug Administration (FDA) is revising the prescription and over- the-counter (OTC) labels for a class of drugs called proton pump inhibitors to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications. Proton pump inhibitors work by reducing the amount of acid in the stomach. Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimovo are available by prescription to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prilosec OTC, Zegerid OTC, and Prevacid 24HR are sold over-the- counter (OTC) for the treatment of frequent heartburn. The new safety information is based on FDAs review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with proton pump inhibitor use. Some studies found that those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more (see Data Summary section). The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over- the-counter), as a precaution, the “Drug Facts“ label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. Healthcare professionals and users of proton pump inhibitors should be aware of the possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors, and weigh the known benefits against the potential risks when deciding to use them. Health Care Guideline: Diagnosis and Treatment of OsteoporosisSixth Edition September 2008I ICSINSTITUTE FOR CLINICAL SYSTEMS IMPROVEMENTThe information contained in this ICSI Health Care Guideline is intended primarily for health profes- sionals and the following expert audiences: physicians, nurses, and other health care professional and provider organizations; health plans, health systems, health care organizations, hospitals and integrated health care delivery systems; health care teaching institutions; health care information technology departments; medical specialty and professional societies; researchers; federal, state and local government health care policy makers and specialists; and employee benefit managers. This ICSI Health Care Guideline should not be construed as medical advice or medical opinion related to any specific facts or circumstances. If you are not one of the expert audiences listed above you are urged to consult a health care professional regarding your own situation and any specific medical questions you may have. In addition, you should seek assistance from a health care professional in interpreting this ICSI Health Care Guideline and applying it in your individual case. This ICSI Health Care Guideline is designed to assist clinicians by providing an analytical framework for t