FDA: Possible increased risk of thigh bone fracture with bisphosphonates

The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk.

Bisphosphonates inhibit the loss of bone mass in people with osteoporosis. Bisphosphonates have been shown to reduce the rate of osteoporotic fractures -- fractures that can result in pain, hospitalization, and surgery-- in people with osteoporosis. While it is not clear whether bisphosphonates are the cause, atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates. The optimal duration of bisphosphonate use for osteoporosis is unknown, and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years.

The labeling changes and Medication Guide will affect only those bisphosphonates approved for osteoporosis, including oral bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and their generic products, as well as injectable bisphosphonates such as Reclast and Boniva.

Labeling changes and the Medication Guide will not apply to bisphosphonates used for Paget’s disease or cancer/hypercalcemia such as Didronel, Zometa, Skelid, and their generic products.

“The FDA is continuing to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment,” said RADM Sandra Kweder, M.D., deputy director, Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. "In the interim, it’s important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis.”

Today’s warning follows a March 10, 2010, Drug Safety Communication announcing the FDA’s ongoing safety review of bisphosphonate use and the occurrence of atypical femur fractures. The FDA has since reviewed all available data on bisphosphonate use, including data summarized in the American Society for Bone Mineral Research Task Force report. The report recommended additional product labeling, better identification and tracking of patients experiencing these breaks, and more research to determine whether and how these drugs cause the serious but uncommon fractures.

Based on the FDA’s review, the Warnings and Precautions section of all bisphosphonate products for osteoporosis will be revised, and the FDA will require the inclusion of a Medication Guide to better inform patients of the possible increased fracture risk.

The FDA recommends that health care professionals be aware of the possible risk in patients taking bisphosphonates and consider periodic reevaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.

Patients taking bisphosphonates for osteoporosis should not stop using their medication unless told to do so by their health care professional. Those taking bisphosphonates also should report any new thigh or groin pain to their health care provider and be evaluated for a possible femur fracture. Patients and health care professionals should report side effects with the use of bisphosphonates to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling (800) 332-1088.

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Study Results Raise Questions About Vertebroplasty for Patients With Osteoporotic Spinal Compression Fractures

A new study led by Mayo Clinic researchers has found that relief of pain from vertebral compression fractures, as well as improvement in pain-related dysfunction, were similar in patients treated with vertebroplasty and those treated with simulated vertebroplasty without cement injections. The article, "A Randomized Controlled Trial of Vertebroplasty for Osteoporotic Spine Fractures," was released today in the New England Journal of Medicine.

Vertebroplasty is a widely applied procedure in which medical cement is injected into the spine to relieve pain and improve function in patients who have osteoporotic fractures. This study, funded by the National Institutes of Health, was the first of its kind, using a double-blinded research model to examine the impact of vertebroplasty.

"Though the medical community has been using vertebroplasty for many years, there were no research results to prove whether the efficacy of the treatment relates to the cement injections, patient expectations, or other factors," says the study's leader, David Kallmes, M.D., a Mayo Clinic physician who specializes in radiology and neurosurgery.

"The cement is a permanent medical implant, and there is some concern that it places patients at future risk for additional spinal fractures."

Researchers from eight medical centers in the United States, United Kingdom and Australia enrolled a total of 131 patients in the trial. The baseline characteristics of pain and function were similar in the vertebroplasty group containing 68 patients and the control group containing 63 patients. Within days of treatment, both groups showed similar improvements in function and pain. Researchers continue to follow study participants, and one year results will be released at a later date.

"We aren't saying the vertebroplasty doesn't work, because it somehow does," says Dr. Kallmes. "But both sets of patients experienced significant improvements in pain and function a month following the procedure, whether they received cement injections or not. Improvements may be the result of local anesthesia, sedation, patient expectations, or other factors."

"Patients should seek medical advice from their care provider before making a decision about treatment options," Dr. Kallmes advises.

Other centers involved in the research included the University of Washington, Seattle; Nuffield Orthopaedic Centre NHS Trust, Oxford, UK; St. George Hospital, University of New South Wales, Sydney, Australia; Gartnavel General Hospital, Glasgow, UK; Department of Social Medicine, Bristol, UK; Nottingham University Hospital NHS Trust, UK; and Western General Hospital, University of Edinburgh, UK. University of Washington researcher Jerry Jarvik, M.D., coordinated the data gathering and analysis for the project.

Dr. Kallmes says that several related research projects are in progress at Mayo Clinic, including a study of kyphoplasty, which uses a balloon to make space for cement injections, as well as an unblinded trial to measure the impact of local anesthesia on pain.
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FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures

The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.

“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health, FDA. “While the software doesn't fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”

Implantable defibrillators are used to treat patients at risk of experiencing life-threatening heart rhythm abnormalities. Should an abnormality occur, the defibrillator delivers a pulse of energy through a lead, a thin electronic wire, shocking the heart back into normal rhythm.

The Sprint Fidelis lead, the subject of an October 2007 Medtronic recall, was prone to fracture in a small number of patients, potentially causing the lead to deliver unnecessary shocks or not operate at all. Most of the patients with the Sprint Fidelis lead still have the device implanted because of the surgical risk associated with removal, and are being monitored by their health care providers for potential fracture.

Medtronic's new software feature, called the Lead Integrity Alert, issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Medtronic has agreed to actively monitor the performance of the new software feature in actual use, which will allow both the company and FDA to ensure that the device is protecting patients as intended.

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