Opana ER Pulled from U.S. Market Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On…
NEW YORK (Reuters Health)—There are insufficient data to make evidence-based decisions regarding the benefits and harms of osteoporosis medications in patients with chronic kidney disease (CKD), according to a systematic review and meta-analysis. “We found low to moderate evidence for the effects of some but not all of the medications, and the evidence was limited…
Glucocorticoids are widely prescribed by rheumatologists, and the effects of daily and cumulative doses of these drugs on bone mineral density (BMD) are important elements of a draft clinical guideline document presented on Nov. 13 at the 2016 ACR/ARHP Annual Meeting in Washington, D.C. Leaders of the ACR guideline project discussed their recommendations at the…
The use of proton pump inhibitors may lead to changes in bone mineral density and an increased risk of developing osteoporosis…
NEW YORK (Reuters Health)—The combination of denosumab and teriparatide improves bone microarchitecture and estimated strength more than either drug alone in women with severe postmenopausal osteoporosis, researchers have found. Dr. Joy Tsai, from Massachusetts General Hospital in Boston, and colleagues conducted a single-site, two-year, open-label, randomized controlled trial involving 94 women aged 45 or older…
SAN FRANCISCO—Post-menopausal women with osteoporosis, previously treated with oral bisphosphonates, had greater increases in bone density when taking denosumab compared with zoledronic acid over a year’s time, according to a study presented at the 2015 ACR/ARHP Annual Meeting. The findings were discussed in the Discovery 2015 plenary session, which focused on new research. In the…
The ACR has continued its advocacy to ensure the safe adoption of biosimilars in the U.S., most recently addressing an FDA public hearing. Also, the FDA has approved tofacitinib for RA, and a clinical trial of romosozumab for patients with osteoporosis met its primary endpoint…
Prior to the widespread use of bisphosphonates for the management of osteoporosis, multiple myeloma and metastatic cancer to the skeletal system, osteonecrosis of the jawbones was an infrequent condition seen after radiation for oral cancers (osteoradionecrosis) and in chronic odontogenic infections.1 Since the mid-2000s, osteonecrosis of the jawbones has been noted to occur as a…
NEW YORK (Reuters Health)—Growth hormone is associated with a decrease in fractures in women with postmenopausal osteoporosis even a decade after treatment ceases, researchers from Sweden report. “We were surprised and pleased to find that the patients had a reduced risk of fracture so many years after the growth hormone treatment was ceased,” Dr. Emily…
Safety The Food and Drug Administration (FDA) has updated the Warnings and Precautions sections of prescribing information for the bisphosphonate agents, including risedronate sodium tablets and combinations with calcium (Actonel/Atelvia), alendronate and combinations with vitamin D (Binosto/Fosamax), ibandronate (Boniva), etidronate (Didronel) and the RANK-ligand inhibitor denosumab (Prolia/Xgeva).1 This information relates to an increased risk for…