| ACTONEL | FDA | 2010-3-10 | ACTONEL-FDA-2010-3-10 | 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.
FDA's review of these data did not show an increase in this risk in women using these medications.
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.
This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs.
Healthcare professionals should continue to follow the recommendations in the drug label when prescribing oral bisphosphonates.
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| ACTONEL | FDA | 2008-1-7 | ACTONEL-FDA-2008-1-7 | FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates.
Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.
The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates.
Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution.
The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.
Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.
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| ACTONEL | FDA | 2008-1-7 | ACTONEL-FDA-2008-1-7 | Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals [Posted 11/12/2008] FDA issued an update to the Agency's review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug.
Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget�(TM)s disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer.
FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years.
The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events.
Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed.
Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation.
Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication.
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| ACTONEL | FDA | 2007-10-1 | ACTONEL-FDA-2007-10-1 | FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates.
Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget�(TM)s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.
FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation.
In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast.
Most cases of atrial fibrillation occurred more than a month after drug infusion.
Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.
Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted.
Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.
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