Monitoring adverse drug reactions associated with bisphosphonates therapy among Libyan patients treated in public hospitals: the case of osteonecrosis of the jaw
DOI:
https://doi.org/10.54361/ljmr.v14i1.02Keywords:
Bisphosphonates, Adverse drug reaction, Osteonecrosis of the Jaw, Adverse eventsAbstract
This study was carried out to identify ADE, associated with the use of both PO and IV Bps among Libyan patients. The results indicated that significant number of patients have suffered different ADRs when using this group of medicines, for long period of time including BRONJ. The study has introduced BRONJ as being one of the major bisphosphonate-associated risks that causes decline in patients’ quality of life, and emphasized the importance of early detection of signs and symptoms associated with ONJ, thus reducing its incidence among Bps users. The results underlined the importance of investigating the prevalence of BRONJ among Libyan patients undergoing long-term Bps treatment, as has been emphasized by both TUH’ chief maxillofacial surgeon who introduced the two cases of BRONJ in only one month and the oncology clinical pharmacist who together sensed the aggravating risk of the misuse of this group of drugs and stressed the need to develop special protocol to ensure safe treatment.The study also pointed out the importance of multidisciplinary health team, including a dentist and a pharmacist, to ensure safe and effective use of this group of medications. This study therefore opens the door to investigate the adverse consequences that face patients undergoing bisphosphonate treatment. It also introduces all precautionary measures that should be taken into consideration when prescribing and administering bisphosphonates
References
WHO. Safety of Medicines - A Guide to Detecting and Reporting Adverse Drug Reactions(2002) - Why Health Professionals Need to Take Action. Essential Medicines and Health Products Information Portal - A World Health Organization resource. WHO/EDM/QSM/2002.2.
World Health Organization. (2002) The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products. https://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf, accessed October, 2018.
Drake MT, Clarke BL, Khosla S(2008) Bisphosphonates: mechanism of action and role in clinical practice. Mayo Clin Proc. 83(9);1032-1045. DOI: https://doi.org/10.4065/83.9.1032
NIH Consensus Development Panel on Osteoporosis prevention, diagnosis, and therapy (2001) Osteoporosis prevention, diagnosis and therapy. JAMA. 285(6): 785-95. DOI: https://doi.org/10.1001/jama.285.6.785
Greenspan S, Field-Munves E, Tonino R, et al. (2002) Tolerability of once-weekly alendronate in patients with osteoporosis: A randomized, double-blind, placebo-controlled study. Mayo Clin Proc. 77(10):1044-1052. DOI: https://doi.org/10.4065/77.10.1044
Harris ST, Watts NB, Genant HK, et al. (1999) Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: A randomized controlled trial. J Am Med Assoc. 282(14):1344-1352. DOI: https://doi.org/10.1001/jama.282.14.1344
Chesnut CH, Skag A, Christiansen C, et al. (2004) Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res. 19 (8): 1241-1249. DOI: https://doi.org/10.1359/JBMR.040325
Reid IR, Brown JP, Burckhardt P, et al. (2002) Intravenous zoledronic acid in postmenopausal women with low bone mineral density. N Engl J Med.346: 653-661. DOI: https://doi.org/10.1056/NEJMoa011807
MacLean C, Newberry S, Maglione M, et al. (2008) Systematic review: Comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med.148(3):197-213. DOI: https://doi.org/10.7326/0003-4819-148-3-200802050-00198
Reid IR, Miller P, Lyles K, et al. (2005) Comparison of a Single Infusion of Zoledronic Acid with Risedronate for Paget’s Disease. N Engl J Med. 353(9):898-908. DOI: https://doi.org/10.1056/NEJMoa044241
Hewitt RE, Lissina A, Green AE, Slay ES, Price DA, Sewell AK (2005) The bisphosphonate acute phase response: rapid and copious production of proinflammatory cytokines by peripheral blood gd T cells in response to aminobisphosphonates is inhibited by statins. Clin Exp Immunol. 139(1):101-111. DOI: https://doi.org/10.1111/j.1365-2249.2005.02665.x
Fosamax (alendronate) FDA MedWatch Alerts. https://www.drugs.com/fda-alerts/116-46.html. Accessed October 17, 2018.
DK W, JT C (2005) Alendronate and risedronate: Reports of severe bone, joint, and muscle pain.Arch Intern Med. 165(3):346-347.
Maalouf NM, Heller HJ, Odvina CV, Kim PJ, Sakhaee K (2006) Bisphosphonate-induced hypocalcemia: report of 3 cases and review of literature. Endocr Pract. 12(1):48-53. DOI: https://doi.org/10.4158/EP.12.1.48
Mishra A, Wong L, Jonklaas J (2001) Prolonged, symptomatic hypocalcemia with pamidronate administration and subclinical hypoparathyroidism. Endocrine.14: 159-164. DOI: https://doi.org/10.1385/ENDO:14:2:159
Whitson HE, Lobaugh B, Lyles KW(2006) Severe hypocalcemia following bisphosphonate treatment in a patient with Paget’s disease of bone. Bone. 39(4): 954-958. DOI: https://doi.org/10.1016/j.bone.2006.04.032
Body JJ (2001) Dosing regimens and main adverse events of bisphosphonates. Semin Oncol. 4(11S):49-53. DOI: https://doi.org/10.1053/sonc.2001.25426
Reclast, Zometa (zoledronate) dosing, indications, interactions, adverse effects, and more. https://reference.medscape.com/drug/reclast-zometa-zoledronic-acid-342858#4.Accessed October 17, 2018.
Khosla S, Burr D, Cauley J, et al. (2007) Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 22(10): 1479-1491. DOI: https://doi.org/10.1359/jbmr.0707onj
Woo S Bin, Hellstein JW, Kalmar JR (2006) Systematic review: Bisphosphonates and osteonecrosis of the jaws. Ann Intern Med. 144(10): 753-761. DOI: https://doi.org/10.7326/0003-4819-144-10-200605160-00009
Ruggiero SL, Dodson TB, Assael L a, Landesberg R, Marx RE, Mehrotra B(2009) American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaw. J Oral Maxillofac Surg. 35119-130.
Bamias A, Kastritis E, Bamia C, et al. (2005) Osteonecrosis of the jaw in cancer after treatment with bisphosphonates: Incidence and risk factors. J Clin Oncol.23(34): 8580-8587. DOI: https://doi.org/10.1200/JCO.2005.02.8670
Allen MR, Burr DB(2009) The Pathogenesis of Bisphosphonate-Related Osteonecrosis of the Jaw: So Many Hypotheses, So Few Data. J Oral Maxillofac Surg. 67(5):61-70. DOI: https://doi.org/10.1016/j.joms.2009.01.007
Lin K, Chang J (2015) Structure and properties of hydroxyapatite for biomedical applications. In: Hydroxyapatite (HAp) for Biomedical Applications. doi:10.1016/B978178242033000001-8 DOI: https://doi.org/10.1016/B978-1-78242-033-0.00001-8
Lips P, Van Schoor NM (2011) The effect of vitamin D on bone and osteoporosis. Best Pract Res Clin Endocrinol Metab. 25(4):585-589. DOI: https://doi.org/10.1016/j.beem.2011.05.002
Guidance to Support the Safe Use of Long-Term Oral Bisphosphonate Therapy(2015) http://www.awmsg.org/docs/awmsg/medman/Guidance to Support the Safe Use of Long-term Oral Bisphosphonate Therapy.pdf. Accessed October 17, 2018.
Medicines and Healthcare products Regulatory Agency MHRA. Bisphosphonates: use and safety - (2014) GOV.UK. https://www.gov.uk/government/publications/bisphosphonates-use-and-safety/bisphosphonates-use-and-safety. Accessed October 16, 2018.
Bernareggi A, Rainsford KD (2005) Pharmacokinetics of nimesulide. In: Nimesulide - Actions and Uses. pp. 63-120 (publisher: BirkäuserVerlag Basel/Switzerland). DOI: https://doi.org/10.1007/3-7643-7410-1_2
Nimesulide. https://www.drugbank.ca/drugs/DB04743. Accessed October 18, 2018.
Alendronate (Oral Route) Proper Use - Mayo Clinic. https://www.mayoclinic.org/drugs-supplements/alendronate-oral-route/proper-use/drg-20061571. Accessed October 17, 2018.
Drugs.com. Risedronate Dosage Guide with Precautions - Drugs.com.www.drugs.com/dosage/risedronate.html. Accessed October 18, 2018.
BNF - zoledronic acid. http://services2.ascribe.com:8080/bnf/view/page/local_bnf/PHP4689-zometa.htm. Accessed October 18, 2018.
Hortobagyi GN, Lipton A, Chew HK, Gradishar WJ, Sauter NP, Mohanlal RW. Efficacy and safety of continued zoledronic acid every 4 weeks versus every 12 weeks in women with bone metastases from breast cancer: Results of the OPTIMIZE-2 trial (2014) J Clin Oncol. 32 no.18 - suppl. DOI: https://doi.org/10.1200/jco.2014.32.18_suppl.lba9500
Corso A, Varettoni M, Zappasodi P, et al. (2007) A different schedule of zoledronic acid can reduce the risk of the osteonecrosis of the jaw in patients with multiple myeloma. Leukemia. 21: 1545-1548. DOI: https://doi.org/10.1038/sj.leu.2404682
Downloads
Published
Issue
Section
License
Copyright (c) 2020 Ghazi M Benkura, Aisha H Alrrefay, Manal A Hadod, Reem M Hamad, Amal Y Benkorah (Author)
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.