Bisphosphonate adverse effects, lessons from large databases

Current Opinion in Rheumatology

Volumn 22, Issue 4, 2010, Pages 404-409

  Abrahamsen, Bo ^a,b  

^a GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^b UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

Author keywords

Adverse events; Bisphosphonates; Epidemiology; Osteoporosis

Indexed keywords

ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; RISEDRONIC ACID; ZOLEDRONIC ACID;

ARTHRALGIA; BONE PAIN; CLINICAL TRIAL; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; ESOPHAGUS CANCER; FACE SURGERY; FEMUR SUBTROCHANTERIC FRACTURE; FRAGILITY FRACTURE; GASTROINTESTINAL SYMPTOM; HEART ATRIUM FIBRILLATION; HIP FRACTURE; HUMAN; JAW OSTEONECROSIS; MYALGIA; OSTEOPOROSIS; PATIENT COMPLIANCE; PRIORITY JOURNAL; REVIEW; RISK FACTOR; RISK REDUCTION; SYNOVITIS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BONE DENSITY CONSERVATION AGENTS; DATABASES, FACTUAL; DIPHOSPHONATES; ESOPHAGEAL NEOPLASMS; HUMANS; JAW DISEASES; OSTEONECROSIS; OSTEOPOROSIS;

EID: 77953480361     PISSN: 10408711     EISSN: None     Source Type: Journal    
DOI: 10.1097/BOR.0b013e32833ad677     Document Type: Review

References (35)

1. Brewster W, Gibbs T, Lacroix K, et al. Evolving paradigms in pharmacov-igilance. Curr Drug Saf 2006; 1:127-134.
2. Cadarette SM, Katz JN, Brookhart MA, et al. Comparative gastrointestinal safety of weekly oral bisphosphonates. Osteoporos Int 2009; 20:1735-1747.
3. CartsosVM, Zhu S, Zavras AI. Bisphosphonate use and the risk of adverse jaw outcomes: a medical claims study of 714, 217 people. J Am Dent Assoc 2008; 139:23-30.
4. Pazianas M, Blumentals WA, Miller PD. Lack of association between oral bisphosphonates and osteonecrosis using jaw surgery as a surrogate marker. Osteoporos Int 2008; 19:773-779.
5. Lee P, van der WH, Seibel MJ. Looking beyond low bone mineral density: multiple insufficiency fractures in a woman with postmenopausal osteoporosis on alendronate therapy. J Endocrinol Invest 2007; 30:590-597.
6. Neviaser AS, Lane JM, Lenart BA, et al. Low-energy femoral shaft fractures associated with alendronate use. J Orthop Trauma 2008; 22:346-350.
7. Ing-Lorenzini K, Desmeules J, Plachta O, et al. Low-energy femoral fractures associated with the long-term use of bisphosphonates: a case series from a swiss university hospital. Drug Saf 2009; 32:775-785.
8. Nieves JW, Bilezikian JP, LaneJM, et al. Fragility fractures of the hip and femur: incidence and patient characteristics. Osteoporos Int 2010; 21:399-408.
9. Abrahamsen B, Eiken P, Eastell R. Subtrochanteric and diaphyseal femur fractures in patients treated with alendronate: a register-based national cohort study. J Bone Miner Res 2009; 24:1095-1102.
10. US Food and Drug Administration. Oral Bisphosphonates. Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures. http://www.fda.gov/Saf ety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127. htm. [Accessed 11 April 2010]
11. Wysowski DK. Reports of esophageal cancer with oral bisphosphonate use. N Engl J Med 2009; 360:89-90.
12. Abrahamsen B, Eiken P, Eastell R. More on reports of esophageal cancer with oral bisphosphonate use. N Engl J Med 2009; 360:1789-1790.
13. Vestergaard P, Schwartz K, Pinholt EM, et al. Gastric and Esophagus Events Before and During Treatment of Osteoporosis. Calcif Tissue Int 2010; 86:110-115.
14. Black DM, DelmasPD, Eastell R, et al. Once-yearly zoledronic acid fortreatment of postmenopausal osteoporosis. N Engl J Med 2007; 356:1 809-1822.
15. Cummings SR, Schwartz AV, Black DM. Alendronate and atrial fibrillation. N Engl J Med 2007; 356:1895-1896.
16. Karam R, Camm J, McClung M. Yearly zoledronic acid in postmenopausal osteoporosis. N Engl J Med 2007; 357:712-713.
17. Pazianas M, Compston J, Huang CL. Atrial fibrillation and bisphosphonate therapy. J Bone Miner Res 2010; 25:2-10.
18. Heckbert SR, Li G, Cummings SR, et al. Use of alendronate and risk of incident atrial fibrillation in women. Arch Intern Med 2008; 168:826-831.
19. Sorensen HT, Christensen S, Mehnert F, et al. Use of bisphosphonates among women and risk of atrial fibrillation and flutter: population based case-control study. BMJ 2008; 336:813-816.
20. Abrahamsen B, Eiken P, Brixen K. Atrial fibrillation in fracture patients treated with oral bisphosphonates. J Intern Med 2009; 265:581-592.
21. Grosso A, Douglas I, Hingorani A, et al. Oral bisphosphonates and risk of atrial fibrillation and flutter in women: a self-controlled case-series safety analysis. PLoS One 2009; 4:e4720.
22. US Food and Drug Administration. Review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm079352.htm. [Accessed 11 April 2010]
23. Sedghizadeh PP, Stanley K, Caligiuri M, et al. Oral bisphosphonate use and the prevalence of osteonecrosis of the jaw: an institutional inquiry. J Am Dent Assoc 2009; 140:61-66.
24. Jung TI, Hoffmann F, Glaeske G, Felsenberg D. Disease-specific risk for an osteonecrosis of the jaw under bisphosphonate therapy. J Cancer Res Clin Oncol 2009. [Epub ahead of print]
25. LoJC, O'Ryan FS, Gordon NP et al. Prevalence of Osteonecrosis of the Jaw in Patients With Oral Bisphosphonate Exposure. J Oral Maxillofac Surg 2009. [Epub ahead of print]
26. Liberman UA, Weiss SR, Broll J, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med 1995; 333:1437-1443.
27. Gwynne Jones DP, Savage RL, Highton J. Alendronate-induced synovitis. J Rheumatol 2008; 35:537-538.
28. Bock O, Boerst H, Thomasius FE, et al. Common musculoskeletal adverse effects of oral treatment with once weekly alendronate and risedronate in patients with osteoporosis and ways for their prevention. J Musculoskelet Neuronal Interact 2007; 7:144-148.
29. Courtney AE, Maxwell AP. Chronic kidney disease and bisphosphonate treatment: are prescribing guidelines unnecessarily restrictive? Postgrad Med J 2009; 85:327-330.
30. Toussaint ND, Elder GJ, Kerr PG. Bisphosphonates in chronic kidney disease; balancing potential benefits and adverse effects on bone and soft tissue. Clin J Am Soc Nephrol 2009; 4:221-233.
31. Biswas PN, Wilton LV, Shakir SA. Pharmacovigilance study of alendronate in England. Osteoporos Int 2003; 14:507-514.
32. Phillips E, Knowles S, Weber E, Shear NH. Skin reactions associated with bisphosphonates: a report of 3 cases and an approach to management. J Allergy Clin Immunol 1998; 102:697-698.
33. Musette P, Brandi ML, Cacoub P, et al. Treatment of osteoporosis: recognizing and managing cutaneous adverse reactions and drug-induced hypersensitivity. Osteoporos Int 2010; 21:723-732.
34. French DD, Margo CE. Postmarketing surveillance rates of uveitis and scleritis with bisphosphonates among a national veteran cohort. Retina 2008; 28: 889-893.
35. Zuradelli M, Masci G, Biancofiore G, et al. High incidence of hypocalcemia and serum creatinine increase in patients with bone metastases treated with zoledronic acid. Oncologist 2009; 14:548-556.