A bisphosphonate - It helps make healthy bone and to slow bone loss in patients with Paget's disease... more
FDA Alerts
Special Alerts:
[Posted 01/07/2008] 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. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates and http://www.fda.gov/cder/drug/infopage/bisphosphonates/default.htm.
[Posted 10/01/2007] 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’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 (zoledronic acid). 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. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Bisphosphonates and http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm.
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Osteoporosis
Prevention of osteoporosis in postmenopausal women with risk factors for development of osteoporosis. Risk factors include premature ovarian failure; family history of osteoporosis; a small, slim body frame; cigarette smoking; excessive alcohol use; low dietary calcium intake; sedentary lifestyle; or Caucasian or Asian race.
Treatment of osteoporosis in postmenopausal women.
Prevention of corticosteroid-induced osteoporosis in patients initiating therapy with corticosteroids (daily dosage ≥7.5 mg of prednisone).
Treatment of corticosteroid-induced osteoporosis in patients receiving corticosteroids (daily dosage ≥7.5 mg of prednisone).
American College of Rheumatology considers patients receiving ≥5 mg of prednisone daily for ≥3 months at risk for bone loss. Recommends bisphosphonate therapy for all long-term corticosteroid-treated men, premenopausal women (with caution), and postmenopausal women with or without hormone replacement therapy (combined estrogen and progestin therapy).
Paget’s Disease of Bone
Treatment of Paget's disease of bone (osteitis deformans) in patients with serum alkaline phosphatase concentrations at least twice ULN or who are symptomatic or at risk for future complications.
Dosage and Administration
General
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Use adjunctively with other measures (e.g., weight-bearing exercise, reduction in smoking and alcohol use) to retard further bone loss.
Supplemental calcium and vitamin D recommended if daily dietary intake is inadequate, particularly in patients with Paget’s disease of bone or receiving corticosteroids.
Administration
Administer orally with a full glass (180–240 mL) of plain water at least 30 minutes before the first food or beverage of the day.
Administer in an upright position (sitting or standing). Avoid lying down for at least 30 minutes following administration. (See GI Effects under Cautions.)
Do not suck or chew tablets; potential for oropharyngeal irritation. (See GI Effects under Cautions.)
Do not administer at the same time as other beverages, foods, or mineral supplements containing calcium, aluminum, or magnesium. (See Antacids or Mineral Supplements Containing Divalent Cations under Interactions.)
If a weekly dose is missed, administer the missed dose the morning after it is remembered, followed by resumption of the regular weekly schedule. Do not take 2 risedronate sodium 35-mg tablets on the same day.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Available as risedronate sodium; dosage expressed in terms of the salt.
Continue risedronate as long as patient continues to receive corticosteroid therapy.
Paget’s Disease of Bone
Oral
30 mg once daily for 2 months.
Consider retreatment (same dosage and duration) after a 2-month posttreatment evaluation period if relapse occurs or if initial treatment failed to normalize serum alkaline phosphatase concentrations.
Prescribing Limits
Adults
Paget’s Disease of Bone
Oral
Safety and efficacy not established for >1 course of retreatment.
Special Populations
Hepatic Impairment
Dosage adjustments are not necessary.
Renal Impairment
Dosage adjustments are not necessary in patients with mild to moderate impairment (Clcr ≥30 mL/minute). Use is not recommended in patients with severe impairment (Clcr <30 mL/minute).
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