Main Article Content
Tuberculosis, Inpatients, Adverse Drug Reaction Reporting Systems, Drug Toxicity, Iran
Background: Tuberculosis has been one of the common diseases of human communities. Besides of disease-related complications, there are serious adverse reactions due to Anti-tuberculosis (Anti-TB) drug therapy.
Objectives: To assess the rate of Adverse Drug Reactions (ADRs) induced by Anti-TB drugs in the infectious disease department for a period of one year. To detect serious and preventable recognized ADRs.
Methods: All patients admitted to the infectious disease department at Imam tertiary teaching hospital in Iran who received Anti-TB drugs from July 2001 to July 2002 entered the study. These patients were monitored for ADRs during hospital stay. The ADRs were then classified based on patients and reactions factors. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire, respectively.
Results: During the study period, 83 patients received Anti-TB drugs; of them 44 developed at least one ADR. Total number of 81 ADRs was detected in this study. ADRs were recognized as the major cause of hospital admission in 11 (13.3%) patients. The most frequent system-organ class affected by ADRs was Liver and biliary system (37%). Hepatitis was observed in 21 (25.3%) patients leading to death in two patients.
Conclusion: Anti-TB drugs could cause significant adverse effects both in quantity and severity leading to hospitalization, prolonged hospital stay and even death. More attention is needed to prevent these reactions.
2. Kopanoff DE, Snider DE, Caras GJ. Isoniazid-related hepatitis. Am Rev Respir Dis 1978:117:991-1001.
3. Burman WJ. Reves RR.. Hepatotoxicity from Rifampin plus Pyrazinamide. Lessons for Policymakers and Messages for Care Providers. Am J Respir Crit Care Med 2001; 164: 1112-3.
4. British Thoracic and Tuberculosis Association: Short course chemotherapy in pulmonary tuberculosis. Lancet 1975; 119-24.
5. Tanaja DP, Kaur D. Study on hepatotoxicity and other side effects of antituberculosis drugs. J Indian Med Assoc 1990; 88:278-80.
6. Snider DE, Long MW, Cross FS, Farer LS. Six months Isoniazid and Rifampin therapy for pulmonary tuberculosis: report of a United States Public Health Service cooperative trial. Am Rev Respir Dis 1984; 77:233-42.
7. Sharma SK., Balamurgan A., Saha PK., Pandey RM. Mehra NK. Evaluation of clinical and immunogenetic risk factors for the development of hepatotoxicity during Antituberculosis treatment. Am J Respir Crit Care Med. 2002;166:916-9.
8. World Health Organization. Uppsala Monitoring Center. Safety monitoring of medicinal products, guidelines for setting up and running pharmacovigilance center, Geneva, 1996.
9. Naranjo CA., Busto U., Sellers EM. A method for estimating the probability of Adverse Drug Reactions. Clin Pharmacother 1981; 30:239-45.
10. Hartwig SC., Siegel J., Schneider PJ. Preventability and severity assessment in reporting Adverse Drug Reactions. Am J Hosp Pharm, 1992; 49:2229-32.
11. Schumock GT, Thornton JP. Focusing on the preventability of Adverse Drug Reactions. Hosp Pharm. 1992; 27:538.
12. Yee D, Valiquette C, Pelletier M, Parisien I, Rocher I, Menzies D. Incidence of Serious Side Effects from First-Line Antituberculosis Drugs among Patients Treated for Active Tuberculosis. Am J Resp Crit Care Med. 2003. 167: 1472-7.
13. Gholami K., Shalviri G. Factors associated with preventability, predictability and severity of ADRs. Ann Pharmacother 1999; 33:236-40.
14. Gholami K, Parsa S, Shalviri G, Sharifzadeh M, Assasi N. Anti-infectives-induced adverse drug reactions in hospitalized patients. Pharmacoepidemiol Drug Safe 2005; 14:501-6.
15. Kays MB. Tuberculosis. In: Koda-Kimble MA, Young LY, Kradijan WA, Guglielmo JB, Allfredge BK, Corelli RL. Applied Therapeutics, The Clinical Use of Drugs. Eighth Edition 2005. Lippincott Williams and Wilkins. p.71-83.