ADVERSE DRUG REACTIONS ASSOCIATED WITH THE USE OF RIBAVIRIN IN THE TREATMENT OF SEVERE ACUTE RESPIRATORY SYNDROME (SARS)
Main Article Content
Keywords
SARS, ribavirin, ADR surveillance, hemolytic anemia, hypocalcemia, hypomagnesemia
Abstract
Background
Health Canada’s Special Access Programme (SAP) provided access to nonmarketed formulations of ribavirin (oral and parenteral) to physicians treating patients with probable or suspect SARS from March 14, 2003 to April 26, 2003.
Objectives
To report on an active surveillance programme employed to monitor adverse drug reactions associated with the use of ribavirin in the treatment of SARS.
Methods
A series of notices were sent to hospitals requiring the submission of any and all ADRs associated with the use of ribavirin in the treatment of SARS. The ADRs were coded using ADR terminology of the World Health Organization Collaborating Centre for International Drug Monitoring (WHO-ART). Causality assessments were performed using the assessment algorithm of the WHO.
Results
The SAP authorized access to ribavirin for a total of 246 patients at hospitals in Ontario and British Columbia. A total of 126 ADR reports were received. Hypocalcemia and hypomagnesemia were the most common ADRs reported with 55 and 59 reports respectively. Hemolytic anemia was reported as an ADR in 41 patients and transfusions were reported in 12 cases. Decreased hemoglobin was reported as an ADR in 34 patients and transfusions were reported in 8 cases.
Discussion
The population of patients treated with ribavirin was known and permitted an accurate understanding of the incidence of ADRs. Health care officials are challenged to develop the capacity to ensure that the use of a drug in a novel disease is carried out in a controlled setting to maximize the integrity of data collection and patient protection.
References
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45. Knowles SR, Phillips EJ, Dresser L, Matukas L.Common adverse events associated with the use of ribavirin for severe acute respiratory syndrome in Canada. Clin Infect Dis 2003;37:1139-42.
46. Leong H-N, Ang B, Earnest A, Teoh C, Xu W, Leo Y-S. Investigational use of ribavirin in the treatment of severe acute respiratory syndrome, Singapore, 2003. Trop Med Int Health 2004;9:932-927.
47. Peiris JS, Chu CM, Cheng VC, et al. Clinical progression and viral load in a community outbreak of coronavirus-associated SARS
pneumonia: a prospective study. Lancet 2003;361:1767-72.
48. Wu KL, Lu SN, Changchien CS, et al. Sequential changes of serum aminotransferase levels in patients with severe acute respiratory syndrome. Am J Trop Med Hyg 2004;71:125-128.
49. Loutfy MR, Blatt LM, Siminovitch KA, et al. Interferon alfacon-1 plus corticosteroids in severe acute respiratory syndrome. JAMA 2003;290:3222-3228.
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51. Muller MP, McGeer A, Straus SE, Hawryluck L, Gold WL. Clinical trials and novel pathogens: lessons learned from SARS. Emerg Infect Dis 2004;10:389-94.
52. van Vonderen MG, Bos JC, Prins JM, Wertheim- van Dillen P, Speelman P. Ribavirin in the treatment of severe acute respiratory syndrome (SARS). Neth J Med 2003;61:238-41.
53. Zhaori G. Antiviral treatment of SARS: Can we draw any conclusions? CMAJ 2003;169:1165-1166.
54. Chen Z, Nakamura T. Statistical evidence for the usefulness of Chinese medicine in the treatment of SARS. Phytother Res 2004;18:592-4.
2003;348:2030-1.
2. World Health Organization. WHO issues a global alert about cases of atypical pneumonia. (March 12 2003), http://www.who.int/mediacentre/releases/2003/pr2
2/en/ (May 1, 2003).
3. World Health Organization. Severe Acute Respiratory Syndrome (SARS) - multi-country outbreak. (March 15, 2003)
http://www.who.int/csr/don/2003_03_15/en/ (April 23, 2003).
4. Centers for Disease Control and Prevention.Outbreak of severe acute respiratory syndrome — Worldwide, 2003. MMWR Morb Mortal Wkly Report 2003;52:226-8.
5. Centers for Disease Control and Prevention.Severe acute respiratory syndrome (SARS) and coronavirus testing — United States, 2003. MMWR Morb Mortal Wkly Report 2003;52:297-302.
6. Government of Hong Kong Special Administrative Region Department of Health. Letter to health care professionals on infection control measures for medical clinics in the community. (March 24,2003) http://www.info.gov.hk/dh/ (May 1, 2003).
7. Government of Hong Kong Special Administrative Region Department of Health. HA guideline on the management of severe acute respiratory syndrome
(SARS). (March 27, 2003).
8. Toronto Public Health. Diagnosis and management of cases of “SARS” in Toronto. (Draft dated March 15, 2003).
9. World Health Organization. Severe acute respiratory syndrome (SARS). (March 21, 2003) http://www.who.int/wer/pdf/2003/wer7812.pdf (May 1, 2003).
10. Peiris JSM, Lai ST, Poon LLM, et al. Coronavirus as a possible cause of severe acute respiratory syndrome. Lancet 2003;361:1319-25.
11. Ksiazek TG, Erdman D, Goldsmith C, et al. A novel coronavirus associated with severe acute respiratory syndrome. New Engl J Med
2003;348:1948-51.
12. Drosten C, Günther S, Preiser W, et al. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. New Engl J Med 2003;348:1967-76.
13. Marra MA, Jones SJM, Astell CR, et al. The genome sequence of SARS-associated coronavirus. Science 2003;300:1399-404.
14. Rota PA, Oberste S, Monroe SS, et al. Characterization of a novel coronavirus associated with severe acute respiratory syndrome. Science 2003;300:1394-9.
15. Centers for Disease Control and Prevention.Severe acute respiratory syndrome: Diagnosis/Evaluation. (April 20, 2003)
http://www.who.int/csr/sars/guidelines/en/ (May 2, 2003).
16. World Health Organization. Use of laboratory methods for SARS diagnosis. (May 1, 2003) http://www.who.int/csr/sars/guidelines/en/ (May 2, 2003).
17. Tsang KW, Ho PL, Ooi GC, et al. A cluster of cases of severe acute respiratory syndrome in Hong Kong. New Engl J Med 2003;348:1977-85.
18. Lee N, Hui D, Wu A, et al. A major outbreak of severe acute respiratory syndrome in Hong Kong. New Engl J Med 2003;348:1986-94.
19. Chan-Yeung M, Yu WC. Outbreak of severe acute respiratory syndrome in Hong Kong Special Administrative Region: case report. BMJ 2003;326:850-2.
20. Hsu L-Y, Cheng-Chuan L, Green JA, et al. Severe acute respiratory syndrome (SARS) in Singapore: clinical features of index patients and initial contacts. Emerg Infect Dis 2003:9:713-717.
21. Poutanen SM, Low DE, Henry B, et al. Identification of severe acute respiratory syndrome in Canada. New Engl J Med 2003;348:1995-2005.
22. Booth CM, Matukas LM, Tomlinson GE, et al. Clinical features and short-term outcomes of 144 patients with SARS in the Greater Toronto Area. JAMA 2003;289:2801-9.
23. Avendano M, Derkach P, Swan S. Clinical course and management of SARS in health care workers in Toronto: a case series. CMAJ 2003;168:1649-60.
24. Tsang K, Zhong NS. SARS: pharmacotherapy. Respirology 2003;8:25-30.
25. Sung JJY, Wu A, Joynt GM, et al. Severe acute respiratory syndrome: report of treatment and outcome after a major outbreak. Thorax 2004;59:414-420.
26. Ho JC, Ooi GC, Mok TY, et al. High dose pulse versus nonpulse corticosteroid regimens in severe acute respiratory syndrome. Am J Resp Crit Care 2003;168:1449-56.
27. Health Canada. Management of Severe Acute Respiratory Syndrome (SARS): interim recommendations for health care providers. (March 29, 2003) http://www.hc-sc.gc.ca/pphb- dgspsp/sars-sras/pdf/sarsclinicalmanagement-29-03-03v10a_e.pdf (April 1, 2003).
28. So LK, Lau AC, Yam LY, et al. Development of a standard treatment protocol for severe acute respiratory syndrome. Lancet 2003;361:1615-7.
29. Canadian Pharmacists Association. Rebetron. Compendium of Pharmaceuticals and Specialties. 38th Ed. 2003:1434-1437.
30. Canadian Pharmacists Association. Pegetron.Compendium of Pharmaceuticals and Specialties. 38th Ed. 2003:1265-9.
31. Canadian Pharmacists Association. Virazole. Compendium of Pharmaceuticals and Specialties. 38th Ed. 2003:1848.
32. Sidwell RW, Huffman JH, Khare GP, et al. Broad- spectrum antiviral activity of Virazole: 1-- ribofuranosyl-1,2,4-triazole-3-carboxamide. Science 1972;177:705-6.
33. Micromedex Thomson Healthcare. Ribavirin Systemic. United States Pharmacopeia Dispensory Information – Volume 1, 22nd Ed., 2002:2526-9.
34. Koren G, King S, Knowles S, Phillips E. Ribavirin in the treatment of SARS: A new trick for an old drug? CMAJ 2003;168:1289-92.
35. McCormick JB, King IJ, Webb PA, et al. Lassa fever. Effective therapy with ribavirin. N Engl J Med 1986;314:20-6.
36. Huggins JW, Hsiang CM, Cosgriff TM, et al. Prospective, double-blind, concurrent, placebo- controlled clinical trial or intravenous ribavirin therapy of hermorrhagic fever with renal syndrome. J Infect Dis 1991;164:1119-27.
37. Health Canada. Severe acute respiratory syndrome (SARS): Case definitions. (April 2, 2003) http://www.hc-sc.gc.ca/pphb-dgspsp/sars- sras/pdf/sars-casedef-0402_e.pdf (May 2, 2003).
38. World Health Organization Collaborating Centre for International Drug Monitoring. Adverse Reaction Terminology. (September 27, 1997)
http://www.who-umc.org/ (May 2, 2003).
39. World Health Organization Collaborating Centre for International Drug Monitoring. Causality assessment of suspected adverse reactions. (September 27, 1997) http://www.who-umc.org/ (May 2, 2003).
40. Naylor D, Basrur S, Bergeron MG, et al. Learning from SARS. Renewal of public health in Canada. Ottawa: Health Canada, 2003.
41. Edwards, IR. Spontaneous reporting-of what? Clinical concerns about drugs. Br. J Clin Pharmaco 1999;48:138-141.
42. Dunn N, Mann RD. Prescription-event and other forms of epidemiological monitoring of side- effects in the UK. Clin Exp Allergy 1999;29:217-239.
43. Health Canada. Guidelines for reporting adverse reactions to marketed drugs. (July 2001) http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-pt/industry_guidelines_e.html (March 28, 2003).
44. Pockros PJ, Reindollar R, McHutchinson J, et al.The safety and tolerability of daily infergen plus ribavirin in the treatment of naïve chronic hepatitis C patients. J Viral Hepatitis 2003;10:55-60.
45. Knowles SR, Phillips EJ, Dresser L, Matukas L.Common adverse events associated with the use of ribavirin for severe acute respiratory syndrome in Canada. Clin Infect Dis 2003;37:1139-42.
46. Leong H-N, Ang B, Earnest A, Teoh C, Xu W, Leo Y-S. Investigational use of ribavirin in the treatment of severe acute respiratory syndrome, Singapore, 2003. Trop Med Int Health 2004;9:932-927.
47. Peiris JS, Chu CM, Cheng VC, et al. Clinical progression and viral load in a community outbreak of coronavirus-associated SARS
pneumonia: a prospective study. Lancet 2003;361:1767-72.
48. Wu KL, Lu SN, Changchien CS, et al. Sequential changes of serum aminotransferase levels in patients with severe acute respiratory syndrome. Am J Trop Med Hyg 2004;71:125-128.
49. Loutfy MR, Blatt LM, Siminovitch KA, et al. Interferon alfacon-1 plus corticosteroids in severe acute respiratory syndrome. JAMA 2003;290:3222-3228.
50. Health Canada. Management of Severe Acute Respiratory Syndrome (SARS) in adults: Interim guidance for health care providers. (July 2003) http://www.hc-sc.gc.ca/pphb-dgspsp/sars- sras/pdf/sars-clin-guide-20030703_e.pdf (July 2003).
51. Muller MP, McGeer A, Straus SE, Hawryluck L, Gold WL. Clinical trials and novel pathogens: lessons learned from SARS. Emerg Infect Dis 2004;10:389-94.
52. van Vonderen MG, Bos JC, Prins JM, Wertheim- van Dillen P, Speelman P. Ribavirin in the treatment of severe acute respiratory syndrome (SARS). Neth J Med 2003;61:238-41.
53. Zhaori G. Antiviral treatment of SARS: Can we draw any conclusions? CMAJ 2003;169:1165-1166.
54. Chen Z, Nakamura T. Statistical evidence for the usefulness of Chinese medicine in the treatment of SARS. Phytother Res 2004;18:592-4.
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ADVERSE DRUG REACTIONS ASSOCIATED WITH THE USE OF RIBAVIRIN IN THE TREATMENT OF SEVERE ACUTE RESPIRATORY SYNDROME (SARS). (2018). Journal of Population Therapeutics and Clinical Pharmacology, 12(1). https://jptcp.com/index.php/jptcp/article/view/79
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How to Cite
ADVERSE DRUG REACTIONS ASSOCIATED WITH THE USE OF RIBAVIRIN IN THE TREATMENT OF SEVERE ACUTE RESPIRATORY SYNDROME (SARS). (2018). Journal of Population Therapeutics and Clinical Pharmacology, 12(1). https://jptcp.com/index.php/jptcp/article/view/79