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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FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women

The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis.

People with osteoporosis at high risk for fracture include those that have had an osteoporotic fracture, or have multiple risk factors for fracture; or those who have failed or are intolerant to other available osteoporosis therapy. Prolia works to decrease the destruction of bone and increase bone mass and strength. An injection of Prolia is recommended once every six months.

“Due to its prevalence, osteoporosis is a serious concern to public health,” said Julie Beitz, M.D., director of the FDA’s Office of Drug Evaluation III. “The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.”

The safety and efficacy of Prolia in the treatment of postmenopausal osteoporosis was demonstrated in a three-year, randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the study, Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

The most common side effects reported with Prolia include back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcaemia (low calcium levels in the blood), serious infections, including infections of the skin, and dermatologic reactions such as dermatitis, rashes, and eczema.

Prolia causes significant suppression of bone turnover and this suppression may contribute to the occurrence of osteonecrosis of the jaw, a severe bone disease that affects the jaw, atypical fractures, and delayed fracture healing.

Prolia was approved with a risk evaluation and mitigation strategy (REMS) that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of the drug.

Prolia is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks, Calif.-based Amgen Inc.

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Vertebroplasty for Patients With Osteoporosis Provides Effective Pain Relief

/PRNewswire/ -- Patient selection is key for vertebroplasty--a minimally invasive treatment performed by interventional radiologists in individuals with painful osteoporotic vertebral compression fractures that fail to respond to conventional medical therapy--to be effective and successful, according to a study of more than 1,500 persons who were followed over seven years. Additionally, collaboration between an interventional radiologist and other medical experts in treating a patient is imperative, say researchers at the Society of Interventional Radiology's 35th Annual Scientific Meeting in Tampa, Fla.

"Vertebroplasty puts lives and vertebrae back together," said Giovanni C. Anselmetti, M.D., interventional radiologist at the Institute for Cancer Research and Treatment in Turin, Italy. Before treatment, many osteoporotic patients are in constant pain and cannot manage everyday activities. Vertebroplasty, a minimally invasive treatment performed by interventional radiologists under imaging guidance, stabilizes collapsed vertebrae with the injection of medical-grade bone cement into the spine. The treatment provides pain relief and improves one's quality of life--if given to appropriately selected candidates in whom conventional medical treatment has failed (such as analgesics or narcotic drugs that provide minimal or no pain release or doses that are intolerable), he further explained. "Our long-term follow-up confirmed this: pain relief and quality of life significantly improved with vertebroplasty," said Anselmetti.

Osteoporosis, the most common type of bone disease, is characterized by low bone mass and structural deterioration of the bone, resulting in an increased susceptibility to fractures. Osteoporosis affects 10 million Americans and is responsible for 700,000 vertebral fractures each year. Multiple vertebral fractures can result in chronic pain and disability, loss of independence, stooped posture and compression of the lungs and stomach.

"Vertebroplasty dramatically improves back pain within hours of the procedure, provides long-term pain relief and has a low complication rate, as demonstrated in multiple studies," said Anselmetti. Vertebroplasty provides pain relief from the complications of osteoporosis (vertebral fractures) but not the disease that caused it (osteoporosis), said Anselmetti. "For the best results, collaboration between physicians is mandatory. All osteoporotic patients need to be followed by an interventional radiologist, who determines which patients are appropriate candidates to receive vertebroplasty treatment, and an experienced medical expert (in this study, a rheumatologist) to ensure continued treatment for osteoporosis," he said.

Anselmetti illustrated a typical case: an 80-year-old Italian woman, who was diagnosed last year with two painful osteoporotic vertebral collapses, underwent medical treatment for osteoporosis (with the drug teriparatide) and was still in pain when she was prescribed an external brace. After there was evidence of two new fractures (verified by MR imaging), she received vertebroplasty, experiencing "complete pain regression, no need for the brace and a dramatic Lazarus-like ability to perform daily activities," he noted.

Researchers studied 2,251 osteoporotic patients (1,811 women; average age, 65) suffering from back-pain for vertebral collapses (MRI confirmed) who underwent a clinical interview; their medical treatment, pain grade, quality of life and extent of vertebral fracture were reviewed. Vertebroplasty was performed in 1,542 patients (1,302 women; average age, 73) when optimal medical treatment (such as biphosphonates, teriparatide, analgesics and back brace) did not help relieve pain or improve quality of life for patients over a three-month period. After vertebroplasty, patients continued to receive medical treatment with a rheumatologist. Because interventional radiologists use high-quality, image-guiding systems (such as digital flat-panel fluoroscopy with built-in rotational image acquisition), treatment time is decreased, making for a safer procedure, added Anselmetti.

In 1,494 patients (96.9 percent), the average pretreatment pain score on the 11-point visual analog scale was 8.2+/-1.8, and it dropped "significantly" to an average of 1.1+/-1.6 after vertebroplasty treatment, said Anselmetti. A patient's ability to manage everyday life--such as washing, dressing or standing--was measured by the commonly used Oswestry Disability Questionnaire, which was completed by patients before and after vertebroplasty. The ODQ scores changed from an average of 68.7+/-7.6 percent to 18.5+/-8.2 percent. Long-term follow-up (average, 31.2 months) in 1,017 patients (857 women; average age, 72) showed the VAS significantly dropping from 7.9+/-1.5 to 1.3+/-1.7. Of the 757 patients wearing a back brace before vertebroplasty, 683 could stop wearing one after treatment.

Anselmetti said that additional studies need to be performed, such as a large randomized trial comparing conventional medical treatment to medical treatment plus vertebroplasty. In Europe, this is difficult, as patients with chronic back pain for vertebral osteoporotic fractures prefer to be treated by vertebroplasty--and not randomized into a medical treatment-only group. "Patients who are in so much pain ask if they can be considered for vertebroplasty treatment," said the co-author of "Percutaneous Vertebroplasty (PV) in the Osteoporotic Patients: Optimal Indications and Patient Selection to Improve Clinical Outcome: Personal Experience in 1,542 Patients Over Seven Years' Experience."

More information about the Society of Interventional Radiology, interventional radiologists and vertebroplasty can be found online at www.SIRweb.org.

Abstract 16: "Percutaneous Vertebroplasty (PV) in the Osteoporotic Patients: Optimal Indications and Patient Selection to Improve Clinical Outcome: Personal Experience in 1,542 Patients Over Seven Years' Experience," G.C. Anselmetti, A. Manca, G. Chiara, G. Iussich and D. Regge, all at the Institute for Cancer Research and Treatment, Candiolo, Italy; and G. Isaia, University of Turin, Turin, Italy, SIR 35th Annual Scientific Meeting March 13-18, 2010, Tampa, Fla. This abstract can be found at www.SIRmeeting.org.

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Staying One Step Ahead of Osteoporosis

/PRNewswire-USNewswire/ -- Facts about osteoporosis are staggering. 75 million baby boomers are approaching the age where the disease is tightening its grip on their bones. Osteoporosis (http://orthoinfo.aaos.org/topic.cfm?topic=A00232) also contributes to an estimated 1.5 million bone fractures in the United States annually. According to new information presented today at the 2009 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) (http://www.aaos.org/), new steps to manage bone health and increase communication, will significantly help reduce the rate of fractures and increase the quality of life for the aging population.

"Decreasing the rate of hip fractures saves lives, prevents loss of function, and decreases costs," said Tad Funahashi, MD, regional chief of orthopedic surgery and assistant area medical director for Kaiser Permanente Southern California, and clinical professor of orthopaedic surgery at the University of California Irvine's College of Medicine. "If we screen for osteoporosis at the earliest onset of the disease," said Dr. Funahashi, "we can implement treatment and help to decrease the rate of hip fractures by 45 percent." Hip Fractures and Osteoporosis Study 474 (http://www3.aaos.org/education/anmeet/anmt2009/podium/podium.cfm?Pevent=474)

Osteoporosis is also a huge problem in other parts of the world. In another study, Leonid Kandel, MD, an orthopaedic surgeon at Hadassah-Hebrew University Medical Center in Jerusalem, Israel, looked at improving the diagnosis rate of osteoporosis in post menopausal women, who fracture the distal radius bone, which is located in the lower arm, near the wrist. Dr. Kandel says these fractures are often the first clinical symptom of osteoporosis, yet only 15 to 25 percent of these women are referred for a bone density test by a family physician after the fracture.

"It is important that patients understand the connection between their current problem, the fracture, and the possibility that the underlying cause is osteoporosis." Dr. Kandel also suggests that there should be a stronger connection and better communication between the hospital and the community. He feels this will increase the number of patients who are diagnosed and treated for the disease. Osteoporosis in Women after Distal Radius Fracture Study 475 (http://www3.aaos.org/education/anmeet/anmt2009/podium/podium.cfm?Pevent=475)

Francesco Pegreffi, MD, an orthopaedic surgeon in the Department of Shoulder and Elbow Surgery at Cervesi Hospital, Cattolica, Italy, along with Lorena Belletti, MD, and Professor Maria Teresa Mascia, in the Department of Rheumatology, University of Modena, Italy, studied a group of patients, 80 percent women and 20 percent men, who were affected by rheumatoid arthritis and under Vitamin D supplementation. "We wanted to analyze the correlation between a person's age, sex, how long they had rheumatoid arthritis, whether they were taking Vitamin D supplements and whether they had fragility fractures due to osteoporosis," said Dr. Pegreffi.

"We found that women affected by rheumatoid arthritis for more than three years were osteoporotic and had a fracture risk significantly higher than those without the disease. Also, Vitamin D therapy is not enough to prevent further bone loss and fragility fractures in these patients." Men in the study faired much better. Those with rheumatoid arthritis did not have a significant risk of fracture. Risk Factors in Osteoporotic Patients Study 477 (http://www3.aaos.org/education/anmeet/anmt2009/podium/podium.cfm?Pevent=477)

Fractures, especially in adults, maybe a tip off or early warning sign, that osteoporosis could be an issue. Many of these are painful fractures of the hip, spine, wrist, arm and leg, which often occur as a result of a fall or even a simple household task. One in two women and one in five men older than 65 years old, will sustain bone fractures caused by osteoporosis.

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Problems with Boniva, Actonel & Fosamax

Many are taking Fosamax, Boniva and other similar drugs designed to stave off osteoporosis. Here's two articles we encourage you to read:

Fosamax, Boniva & Actonel Linked To Jaw Bone Disorders

http://injury-law.freeadvice.com/drug-toxic_chemicals/fosamax-linked-to-jaw-bone-disorders.htm

Merck Braces for Flood of Fosamax Lawsuits
Osteoporosis Medication Can Destroy Patients' Jawbones

http://www.consumeraffairs.com/news04/2007/02/fosamax.html