Adverse drug reactions to fluoroquinolone antibiotics - Analysis of reports received in a tertiary care hospital

J. Jose, P.G.M. Rao, B. Jimmy

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Fluoroquinolones are one among the most commonly prescribed antibiotics in hospital set up. Only few published studies are available which tried to characterize the nature of ADRs to fluoroquinolones encountered in a hospital set up. The present study was aimed at analyzing the pattern of ADRs implicated to fluoroquinolone antibiotics reported spontaneously to the ADR reporting unit of a tertiary care teaching hospital in India. ADRs reported over a period of 4 years and 6 months were analyzed. Evaluation was done for patient demographics, drug and reaction characteristics, predisposing factors, and outcome of reactions. Analysis for causality, severity and preventability was also done. Eighty ADRs associated with fluoroquinolones were notified during the evaluation period, which accounted for 5.4% of the total ADRs reported in the ADR reporting unit and 30.2% of all reports to antibacterials. Type A reactions (58.8%) accounted for majority and more were described to be common (48.8%) in the literature. Levofloxacin (48.8%) occupied the major share of the reactions reported. Pattern of ADRs observed was comparable to that reported in literature. The organ system most commonly affected was skin and appendages (32.5%) and the most frequently reported reaction was skin rash (21.3%). Interestingly, no report of reactions affecting musculoskeletal system was observed while rare reaction like nephrotoxicity was noticed. The proportion of nervous system adverse reactions noticed were higher than that observed with antibacterial agents in general. Drug dechallenge was instituted in majority (73.8%) for management of the reactions, while additional treatment was instituted in 50% of the reactions. More of the reactions were probable (52.5%) in nature on causality assessment and were of moderate (72.5%) severity. Many (23.8%) of the reactions were deemed to be preventable on evaluation. Drug-drug and drug-disease interaction were the most important factors which contributed to preventability. Even though ADRs to fluoroquinolones are considered mainly to be mild in severity, our evaluation revealed considerable number of reactions of moderate severity. The present evaluation has revealed opportunities for interventions especially for the preventable ADRs which will help in promoting safer use of this important group of antibiotics. Cautious use of these agents especially in patients with predisposing factors and proper monitoring is warranted. Spontaneous reporting programs in spite of its limitations are useful in identifying pattern of ADRs in a hospital set up. Similar hospital based evaluation will provide valuable information which would help in promoting safe use of these medications. © 2008 - IOS Press and the authors. All rights reserved.
Original languageEnglish
Pages (from-to)169-180
Number of pages12
JournalInternational Journal of Risk and Safety in Medicine
Volume20
Issue number3
DOIs
Publication statusPublished - 2008
Externally publishedYes

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Fluoroquinolones
Tertiary Healthcare
Drug-Related Side Effects and Adverse Reactions
Tertiary Care Centers
Anti-Bacterial Agents
Causality
Pharmaceutical Preparations
Musculoskeletal System
Levofloxacin
Exanthema
Drug Interactions
Teaching Hospitals
Nervous System
India
Demography
Skin

Cite this

@article{c394b6340a604abe8195e4ed02e31029,
title = "Adverse drug reactions to fluoroquinolone antibiotics - Analysis of reports received in a tertiary care hospital",
abstract = "Fluoroquinolones are one among the most commonly prescribed antibiotics in hospital set up. Only few published studies are available which tried to characterize the nature of ADRs to fluoroquinolones encountered in a hospital set up. The present study was aimed at analyzing the pattern of ADRs implicated to fluoroquinolone antibiotics reported spontaneously to the ADR reporting unit of a tertiary care teaching hospital in India. ADRs reported over a period of 4 years and 6 months were analyzed. Evaluation was done for patient demographics, drug and reaction characteristics, predisposing factors, and outcome of reactions. Analysis for causality, severity and preventability was also done. Eighty ADRs associated with fluoroquinolones were notified during the evaluation period, which accounted for 5.4{\%} of the total ADRs reported in the ADR reporting unit and 30.2{\%} of all reports to antibacterials. Type A reactions (58.8{\%}) accounted for majority and more were described to be common (48.8{\%}) in the literature. Levofloxacin (48.8{\%}) occupied the major share of the reactions reported. Pattern of ADRs observed was comparable to that reported in literature. The organ system most commonly affected was skin and appendages (32.5{\%}) and the most frequently reported reaction was skin rash (21.3{\%}). Interestingly, no report of reactions affecting musculoskeletal system was observed while rare reaction like nephrotoxicity was noticed. The proportion of nervous system adverse reactions noticed were higher than that observed with antibacterial agents in general. Drug dechallenge was instituted in majority (73.8{\%}) for management of the reactions, while additional treatment was instituted in 50{\%} of the reactions. More of the reactions were probable (52.5{\%}) in nature on causality assessment and were of moderate (72.5{\%}) severity. Many (23.8{\%}) of the reactions were deemed to be preventable on evaluation. Drug-drug and drug-disease interaction were the most important factors which contributed to preventability. Even though ADRs to fluoroquinolones are considered mainly to be mild in severity, our evaluation revealed considerable number of reactions of moderate severity. The present evaluation has revealed opportunities for interventions especially for the preventable ADRs which will help in promoting safer use of this important group of antibiotics. Cautious use of these agents especially in patients with predisposing factors and proper monitoring is warranted. Spontaneous reporting programs in spite of its limitations are useful in identifying pattern of ADRs in a hospital set up. Similar hospital based evaluation will provide valuable information which would help in promoting safe use of these medications. {\circledC} 2008 - IOS Press and the authors. All rights reserved.",
author = "J. Jose and P.G.M. Rao and B. Jimmy",
note = "Cited By :8 Export Date: 10 November 2017 CODEN: IJMDE Correspondence Address: Jose, J.; Department of Pharmacy Practice, Shirdi Sai Baba Cancer Hospital, Kasturba Hospital, Manipal, Karnataka, 576 104, India; email: jimmy_jose2001@yahoo.com Chemicals/CAS: ciprofloxacin, 85721-33-1; gatifloxacin, 112811-59-3, 180200-66-2; levofloxacin, 100986-85-4, 138199-71-0; moxifloxacin, 151096-09-2; ofloxacin, 82419-36-1; sparfloxacin, 111542-93-9 References: Alvarez-Requejo, A., Carvajal, A., Begaud, B., Moride, Y., Vega, T., Martin Arias, L.H., Under reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system (1998) Eur. J. Clin. Pharmacol, 54, pp. 483-488; Ball, P., Adverse drug reactions: Implications for the development of fluoroquinolones (2003) J. Antimicrob. Chemother, 51, pp. 21-27; Ball, P., Mandell, L., Niki, Y., Tillotson, G., Comparative tolerability of the newer fluoroquinolone antibacterials (1999) Drug Saf, 21, pp. 407-421; Ball, P., Tillotson, G., Tolerability of fluoroquinolone antibiotics: Past, present and future (1995) Drug Saf, 13, pp. 343-358; Bates, D.W., Leape, L.L., Petrycki, S., Incidence and preventability of adverse drug events in hospitalized adults (1993) J. Gen. Intern. Med, 8, pp. 289-294; Bertino, J., Fish, D., The safety profile of the fluoroquinolones (2000) Clin. Ther, 22, pp. 798-817; Blum, M.D., Graham, D.J., McCloskey, C.A., Temafloxacin syndrome: Review of 95 cases (1994) Clin. Infect. Dis, 18, pp. 946-950; Bristol-Myers Squibb, Tequin (gatifloxacin) prescribing information (revised), Princeton, NJ, 2006; De Sarro, A., De Sarro, G., Adverse reactions to fluoroquinolones. An overview on mechanistic aspects (2001) Curr. Med. Chem, 8, pp. 371-384; Doussau de Bazignan, A., Thiessard, F., Miremont-Salame, G., Conri, C., Haramburu, F., Psychiatric adverse effects of fluoroquinolones: Review of cases from the French pharmacologic surveillance database (2006) Rev. Med. Intern, 27, pp. 448-452; I.R. Edwards, Pharmacological basis of adverse drug reactions, in: Avery's Drug Treatment, N.H.G. Holford and T.M. Speight, eds, Adis International, Auckland, 1997, pp. 261-299; Edwards, I.R., Spontaneous reporting of what? Clinical concerns of drugs (1999) Br. J. Clin. Pharmacol, 48, pp. 138-141; (2005) A guideline on summary of product characteristics, , http://pharmacos.eudra.org/F2/eudralex/vol-2/C/SPCGuidRev0-Dec99.pdf, October; Evans, R.S., Lloyd, J.F., Stoddard, G.J., Neberker, J.R., Samore, M.H., Risk factors for adverse drug events: A 10 year analysis (2005) Ann. Pharmacother, 39, pp. 1161-1168; Field, T.S., Gurwitz, J.H., Avorn, J., McCormick, D., Jain, S., Eckier, M., Risk factors for adverse drug events among nursing home residents (2001) Arch. Intern. Med, 161, pp. 1629-1634; Fish, D.N., Fluoroquinolone adverse effects and drug interactions (2001) Pharmacotherapy, 21, pp. 253S-272S; Fonescue, E.B., Kausbal, R., Landrigan, C.P., McKenna, K.J., Clapp, M.D., Federico, F., Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients (2003) Pediatrics, 111, pp. 722-729; (2005) Approved Drugs Products with Therapeutic Equivalence Evaluations, , Food and Drug Administration Center for Drug Evaluation and Research, 25th edn, US Food and Drug Administration, Bethesda, MD; Galatti, L., Giustini, S.E., Sessa, A., Polimeni, G., Salvo, F., Spina, E., Caputi, A.P., Neuropsychiatric reactions to drugs: An analysis of spontaneous reports from general practitioners in Italy (2005) Pharmacol. Res, 51, pp. 211-216; Gallelli, L., Ferreri, G., Colosimo, M., Pirritano, D., Flocco, M.A., Pelaia, G., Retrospective analysis of adverse drug reactions to bronchodilators observed in two pulmonary divisions of Catanzaro, Italy (2003) Pharmacol. Res, 47, pp. 493-499; Gallelli, L., Ferreri, G., Colosimo, M., Pirritano, D., Guadagnino, L., Pelaia, G., Adverse drug reactions to antibiotics observed in two pulmonology divisions of Catanzaro, Italy, A six year retrospective study (2002) Pharmacol. Res, 46, pp. 395-400; Gandhi, T.K., Weingart, S.N., Borus, J., Seger, A.C., Peterson, J., Burdick, E., Adverse drug events in ambulatory care (2003) N. Eng. J. Med, 348, pp. 1156-1164; Gonzalez-Martin, G., Caroca, C.M., Paris, E., Adverse drug reactions (ADRs) in hospitalized pediatric patients-a prospective study (1998) Int. J. Clin. Pharmacol. Ther, 36, pp. 530-533; Hallgren, J., Tengvall-Linder, M., Persson, M., Wahlgren, C.F., Steven-Johnson syndrome associated with ciprofloxacin: A review of adverse cutaneous events reported in Sweden as associated with this drug (2003) J. Am. Acad. Dermatol, 49, pp. S267-S269; Hartwig, S.C., Siegel, J., Schneider, P.J., Preventability and severity assessment in reporting adverse drug reactions (1992) Am. J. Hosp. Pharm, 49, pp. 2229-2232; Health Canada, Advisory: Health Canada advises diabetic patients not to use the antibiotic Tequin, , www.hc-sc.gc.ca/ahcasc/media/advisories-avis/2006/2006_09_e.html, accessed December 17, 2006; E.F. Hendeshot, Fluoroquinolones, Infect. Dis. Clin. North Am. 9 (1995), 715-730; Kanjanarat, P., Winterstein, A.G., Johns, T.E., Hatton, R.C., Gonzalez-Rothi, R., Segal, R., Nature of preventable adverse drug events in hospitals: A literature review (2003) Am. J. Health Syst. Pharm, 60, pp. 1750-1759; Karande, S.C., Kshirsagar, N.A., Adverse drug reaction monitoring of ciprofloxacin in pediatric practice (1992) Ind. Pediatr, 29, pp. 181-188; Lau, P.M., Stewart, K., Dooley, M.J., Comment: Hospital admissions resulting from preventable adverse drug reactions (2003) Ann. Pharmacother, 37, pp. 303-304; Leone, R., Venegoni, M., Motola, D., Moretti, U., Piazzetta, V., Cocci, A., Resi, D., Conforti, A., Adverse drug reactions related to the use of fluoroquinolone antimicrobials - An analysis of spontaneous reports and fluoroquinolone consumption data from three Italian regions (2003) Drug Saf, 26, pp. 109-120; J.A. Linder, E.S. Huang, M.A. Steinman, R. Gonzales and R.S. Stafford, Fluoroquinolone prescribing in the United States: 1995 to 2002, Am. J. Med. 118 (2005), 259-268; Lomaestro, B.M., Fluoroquinolone induced renal failure (2000) Drug Saf, 22, pp. 479-485; Meyboom, R.H.B., Egberts, A.C.G., Edwards, I.R., Principles of signal detection in pharmacovigilance (1997) Drug Saf, 16, pp. 355-365; Moride, Y., Haramburu, F., Requeyo, A.A., Begaud, B., Underreporting of adverse drug reactions in general practice (1997) Br. J. Clin. Pharmacol, 43, pp. 177-181; Naranjo, C.A., Busto, U., Sellers, E.M., Sandor, P., Ruiz, I., Roberts, E.A., A method for estimating the probability of adverse drug reactions (1981) Clin. Pharmacol. Ther, 30, pp. 239-245; Nicolle, L.E., Fluoroquinolones in the aged (1999) Drugs, 58, pp. 49-51; Owens Jr., R.C., QT prolongation with antimicrobial agents: Understanding the significance (2004) Drugs, 64, pp. 1091-1124; G. Parthasarathi and S. Olsson, Adverse drug reactions, in: A Text Book of Clinical Pharmacy Practice-Essential Concepts and Skills, G. Parthasarathi, K. Nyfort-Hansen and M.C. Nahata, eds, Orient Longman Pvt. Ltd., Chennai, 2004, pp. 86-102; Prod Information, Levaquin (R) tablets, oral solution, injection, Ortho-McNeil Pharmaceuticals, Inc., Raritan, NJ, 2004; Rawlins, M.D., Thompson, J.W., Pathogenesis of adverse drug reactions (1977) Textbook of Adverse Drug Reactions, p. 44. , D.M. Davies, ed, Oxford University Press, Oxford; Reeta, K., Uppal, R., Jhaj, R., Malhotra, S., Bhargava, V.K., Adverse drug reactions to fluoroquinolones in pediatric patients in a tertiary care hospital (2000) Ind. J. Physiol. Pharmacol, 44, pp. 113-114; Regal, B., Finally a pharmacovigilant India (2004) Uppsala Rep, 25, pp. 7-8; Rubinstein, E., History of quinolones and their side effects (2001) Chemotherapy, 47, pp. 3-8; Sachs, B., Riegel, S., Seebeck, J., Beier, R., Schichler, D., Barger, A., Merk, H.F., Erdmann, S., Fluoroquinolone-associated anaphylaxis in spontaneous adverse reaction reports in Germany: Differences in reporting rates between individual fluoroquinolones and occurrence after first ever use (2006) Drug Saf, 29, pp. 1087-1090; Schaeffer, A.J., The expanding role of fluoroquinolones (2002) Am. J. Med, 113, pp. 45S-54S; Schluter, G., Ciprofloxacin: Review of potential toxicological effects (1987) Am. J. Med, 82 (SUPPL. 4A), pp. 91-93; Sprandel, K.A., Rodvold, K.A., Safety and tolerability of fluoroquinolones (2003) Clin. Cornerston, 3 (SUPL.), pp. S29-S36; Stahlmann, R., Lode, H., Fluoroquinolone in the elderly: Safety considerations (2003) Drugs Aging, 20, pp. 289-302; Storm, B.L., What is pharmacoepidemiology? (2000) Pharmacoepidemiology, pp. 3-15. , Wiley, Chichester; Suh, D.C., Woodall, B.S., Shin, S.K., Hermes-De-Santis, E.R., Clinical and economic impact of adverse drug reactions in hospitalized patients (2000) Ann. Pharmacother, 34, pp. 1373-1379; Uppal, R., Jhaj, R., Malhotra, S., Adverse drug reactions to fluoroquinolones at a tertiary care teaching hospital in northern India (1998) J. Assoc. Phys. India, 46, pp. 946-947; Van der Linden, P.D., Sturkenboom, M.C., Herings, R.M., Leufkens, H.G., Stricker, B.H., Fluoroquinolones and risk of Achilles tendon disorders: Case control study (2002) BMJ, 324, pp. 1304-1307; Veehof, L.J.G., Stewart, R.E., Haaijer-Ruskamp, F.M., Meyboom-de Jong, B., The development of polypharmacy. A longitudinal study (2000) Family Practice, 17, pp. 261-267; (2003) WHO Adverse reaction terminology, , WHO-Uppsala Monitoring Center",
year = "2008",
doi = "10.3233/JRS-2008-0441",
language = "English",
volume = "20",
pages = "169--180",
journal = "International Journal of Risk and Safety in Medicine",
issn = "0924-6479",
publisher = "IOS Press",
number = "3",

}

Adverse drug reactions to fluoroquinolone antibiotics - Analysis of reports received in a tertiary care hospital. / Jose, J.; Rao, P.G.M.; Jimmy, B.

In: International Journal of Risk and Safety in Medicine, Vol. 20, No. 3, 2008, p. 169-180.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Adverse drug reactions to fluoroquinolone antibiotics - Analysis of reports received in a tertiary care hospital

AU - Jose, J.

AU - Rao, P.G.M.

AU - Jimmy, B.

N1 - Cited By :8 Export Date: 10 November 2017 CODEN: IJMDE Correspondence Address: Jose, J.; Department of Pharmacy Practice, Shirdi Sai Baba Cancer Hospital, Kasturba Hospital, Manipal, Karnataka, 576 104, India; email: jimmy_jose2001@yahoo.com Chemicals/CAS: ciprofloxacin, 85721-33-1; gatifloxacin, 112811-59-3, 180200-66-2; levofloxacin, 100986-85-4, 138199-71-0; moxifloxacin, 151096-09-2; ofloxacin, 82419-36-1; sparfloxacin, 111542-93-9 References: Alvarez-Requejo, A., Carvajal, A., Begaud, B., Moride, Y., Vega, T., Martin Arias, L.H., Under reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system (1998) Eur. J. Clin. Pharmacol, 54, pp. 483-488; Ball, P., Adverse drug reactions: Implications for the development of fluoroquinolones (2003) J. Antimicrob. Chemother, 51, pp. 21-27; Ball, P., Mandell, L., Niki, Y., Tillotson, G., Comparative tolerability of the newer fluoroquinolone antibacterials (1999) Drug Saf, 21, pp. 407-421; Ball, P., Tillotson, G., Tolerability of fluoroquinolone antibiotics: Past, present and future (1995) Drug Saf, 13, pp. 343-358; Bates, D.W., Leape, L.L., Petrycki, S., Incidence and preventability of adverse drug events in hospitalized adults (1993) J. Gen. Intern. Med, 8, pp. 289-294; Bertino, J., Fish, D., The safety profile of the fluoroquinolones (2000) Clin. Ther, 22, pp. 798-817; Blum, M.D., Graham, D.J., McCloskey, C.A., Temafloxacin syndrome: Review of 95 cases (1994) Clin. Infect. Dis, 18, pp. 946-950; Bristol-Myers Squibb, Tequin (gatifloxacin) prescribing information (revised), Princeton, NJ, 2006; De Sarro, A., De Sarro, G., Adverse reactions to fluoroquinolones. An overview on mechanistic aspects (2001) Curr. Med. Chem, 8, pp. 371-384; Doussau de Bazignan, A., Thiessard, F., Miremont-Salame, G., Conri, C., Haramburu, F., Psychiatric adverse effects of fluoroquinolones: Review of cases from the French pharmacologic surveillance database (2006) Rev. Med. Intern, 27, pp. 448-452; I.R. Edwards, Pharmacological basis of adverse drug reactions, in: Avery's Drug Treatment, N.H.G. Holford and T.M. Speight, eds, Adis International, Auckland, 1997, pp. 261-299; Edwards, I.R., Spontaneous reporting of what? Clinical concerns of drugs (1999) Br. J. Clin. Pharmacol, 48, pp. 138-141; (2005) A guideline on summary of product characteristics, , http://pharmacos.eudra.org/F2/eudralex/vol-2/C/SPCGuidRev0-Dec99.pdf, October; Evans, R.S., Lloyd, J.F., Stoddard, G.J., Neberker, J.R., Samore, M.H., Risk factors for adverse drug events: A 10 year analysis (2005) Ann. Pharmacother, 39, pp. 1161-1168; Field, T.S., Gurwitz, J.H., Avorn, J., McCormick, D., Jain, S., Eckier, M., Risk factors for adverse drug events among nursing home residents (2001) Arch. Intern. Med, 161, pp. 1629-1634; Fish, D.N., Fluoroquinolone adverse effects and drug interactions (2001) Pharmacotherapy, 21, pp. 253S-272S; Fonescue, E.B., Kausbal, R., Landrigan, C.P., McKenna, K.J., Clapp, M.D., Federico, F., Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients (2003) Pediatrics, 111, pp. 722-729; (2005) Approved Drugs Products with Therapeutic Equivalence Evaluations, , Food and Drug Administration Center for Drug Evaluation and Research, 25th edn, US Food and Drug Administration, Bethesda, MD; Galatti, L., Giustini, S.E., Sessa, A., Polimeni, G., Salvo, F., Spina, E., Caputi, A.P., Neuropsychiatric reactions to drugs: An analysis of spontaneous reports from general practitioners in Italy (2005) Pharmacol. Res, 51, pp. 211-216; Gallelli, L., Ferreri, G., Colosimo, M., Pirritano, D., Flocco, M.A., Pelaia, G., Retrospective analysis of adverse drug reactions to bronchodilators observed in two pulmonary divisions of Catanzaro, Italy (2003) Pharmacol. Res, 47, pp. 493-499; Gallelli, L., Ferreri, G., Colosimo, M., Pirritano, D., Guadagnino, L., Pelaia, G., Adverse drug reactions to antibiotics observed in two pulmonology divisions of Catanzaro, Italy, A six year retrospective study (2002) Pharmacol. Res, 46, pp. 395-400; Gandhi, T.K., Weingart, S.N., Borus, J., Seger, A.C., Peterson, J., Burdick, E., Adverse drug events in ambulatory care (2003) N. Eng. J. Med, 348, pp. 1156-1164; Gonzalez-Martin, G., Caroca, C.M., Paris, E., Adverse drug reactions (ADRs) in hospitalized pediatric patients-a prospective study (1998) Int. J. Clin. Pharmacol. Ther, 36, pp. 530-533; Hallgren, J., Tengvall-Linder, M., Persson, M., Wahlgren, C.F., Steven-Johnson syndrome associated with ciprofloxacin: A review of adverse cutaneous events reported in Sweden as associated with this drug (2003) J. Am. Acad. Dermatol, 49, pp. S267-S269; Hartwig, S.C., Siegel, J., Schneider, P.J., Preventability and severity assessment in reporting adverse drug reactions (1992) Am. J. Hosp. Pharm, 49, pp. 2229-2232; Health Canada, Advisory: Health Canada advises diabetic patients not to use the antibiotic Tequin, , www.hc-sc.gc.ca/ahcasc/media/advisories-avis/2006/2006_09_e.html, accessed December 17, 2006; E.F. Hendeshot, Fluoroquinolones, Infect. Dis. Clin. North Am. 9 (1995), 715-730; Kanjanarat, P., Winterstein, A.G., Johns, T.E., Hatton, R.C., Gonzalez-Rothi, R., Segal, R., Nature of preventable adverse drug events in hospitals: A literature review (2003) Am. J. Health Syst. Pharm, 60, pp. 1750-1759; Karande, S.C., Kshirsagar, N.A., Adverse drug reaction monitoring of ciprofloxacin in pediatric practice (1992) Ind. Pediatr, 29, pp. 181-188; Lau, P.M., Stewart, K., Dooley, M.J., Comment: Hospital admissions resulting from preventable adverse drug reactions (2003) Ann. Pharmacother, 37, pp. 303-304; Leone, R., Venegoni, M., Motola, D., Moretti, U., Piazzetta, V., Cocci, A., Resi, D., Conforti, A., Adverse drug reactions related to the use of fluoroquinolone antimicrobials - An analysis of spontaneous reports and fluoroquinolone consumption data from three Italian regions (2003) Drug Saf, 26, pp. 109-120; J.A. Linder, E.S. Huang, M.A. Steinman, R. Gonzales and R.S. Stafford, Fluoroquinolone prescribing in the United States: 1995 to 2002, Am. J. Med. 118 (2005), 259-268; Lomaestro, B.M., Fluoroquinolone induced renal failure (2000) Drug Saf, 22, pp. 479-485; Meyboom, R.H.B., Egberts, A.C.G., Edwards, I.R., Principles of signal detection in pharmacovigilance (1997) Drug Saf, 16, pp. 355-365; Moride, Y., Haramburu, F., Requeyo, A.A., Begaud, B., Underreporting of adverse drug reactions in general practice (1997) Br. J. Clin. Pharmacol, 43, pp. 177-181; Naranjo, C.A., Busto, U., Sellers, E.M., Sandor, P., Ruiz, I., Roberts, E.A., A method for estimating the probability of adverse drug reactions (1981) Clin. Pharmacol. Ther, 30, pp. 239-245; Nicolle, L.E., Fluoroquinolones in the aged (1999) Drugs, 58, pp. 49-51; Owens Jr., R.C., QT prolongation with antimicrobial agents: Understanding the significance (2004) Drugs, 64, pp. 1091-1124; G. Parthasarathi and S. Olsson, Adverse drug reactions, in: A Text Book of Clinical Pharmacy Practice-Essential Concepts and Skills, G. Parthasarathi, K. Nyfort-Hansen and M.C. Nahata, eds, Orient Longman Pvt. Ltd., Chennai, 2004, pp. 86-102; Prod Information, Levaquin (R) tablets, oral solution, injection, Ortho-McNeil Pharmaceuticals, Inc., Raritan, NJ, 2004; Rawlins, M.D., Thompson, J.W., Pathogenesis of adverse drug reactions (1977) Textbook of Adverse Drug Reactions, p. 44. , D.M. Davies, ed, Oxford University Press, Oxford; Reeta, K., Uppal, R., Jhaj, R., Malhotra, S., Bhargava, V.K., Adverse drug reactions to fluoroquinolones in pediatric patients in a tertiary care hospital (2000) Ind. J. Physiol. Pharmacol, 44, pp. 113-114; Regal, B., Finally a pharmacovigilant India (2004) Uppsala Rep, 25, pp. 7-8; Rubinstein, E., History of quinolones and their side effects (2001) Chemotherapy, 47, pp. 3-8; Sachs, B., Riegel, S., Seebeck, J., Beier, R., Schichler, D., Barger, A., Merk, H.F., Erdmann, S., Fluoroquinolone-associated anaphylaxis in spontaneous adverse reaction reports in Germany: Differences in reporting rates between individual fluoroquinolones and occurrence after first ever use (2006) Drug Saf, 29, pp. 1087-1090; Schaeffer, A.J., The expanding role of fluoroquinolones (2002) Am. J. Med, 113, pp. 45S-54S; Schluter, G., Ciprofloxacin: Review of potential toxicological effects (1987) Am. J. Med, 82 (SUPPL. 4A), pp. 91-93; Sprandel, K.A., Rodvold, K.A., Safety and tolerability of fluoroquinolones (2003) Clin. Cornerston, 3 (SUPL.), pp. S29-S36; Stahlmann, R., Lode, H., Fluoroquinolone in the elderly: Safety considerations (2003) Drugs Aging, 20, pp. 289-302; Storm, B.L., What is pharmacoepidemiology? (2000) Pharmacoepidemiology, pp. 3-15. , Wiley, Chichester; Suh, D.C., Woodall, B.S., Shin, S.K., Hermes-De-Santis, E.R., Clinical and economic impact of adverse drug reactions in hospitalized patients (2000) Ann. Pharmacother, 34, pp. 1373-1379; Uppal, R., Jhaj, R., Malhotra, S., Adverse drug reactions to fluoroquinolones at a tertiary care teaching hospital in northern India (1998) J. Assoc. Phys. India, 46, pp. 946-947; Van der Linden, P.D., Sturkenboom, M.C., Herings, R.M., Leufkens, H.G., Stricker, B.H., Fluoroquinolones and risk of Achilles tendon disorders: Case control study (2002) BMJ, 324, pp. 1304-1307; Veehof, L.J.G., Stewart, R.E., Haaijer-Ruskamp, F.M., Meyboom-de Jong, B., The development of polypharmacy. A longitudinal study (2000) Family Practice, 17, pp. 261-267; (2003) WHO Adverse reaction terminology, , WHO-Uppsala Monitoring Center

PY - 2008

Y1 - 2008

N2 - Fluoroquinolones are one among the most commonly prescribed antibiotics in hospital set up. Only few published studies are available which tried to characterize the nature of ADRs to fluoroquinolones encountered in a hospital set up. The present study was aimed at analyzing the pattern of ADRs implicated to fluoroquinolone antibiotics reported spontaneously to the ADR reporting unit of a tertiary care teaching hospital in India. ADRs reported over a period of 4 years and 6 months were analyzed. Evaluation was done for patient demographics, drug and reaction characteristics, predisposing factors, and outcome of reactions. Analysis for causality, severity and preventability was also done. Eighty ADRs associated with fluoroquinolones were notified during the evaluation period, which accounted for 5.4% of the total ADRs reported in the ADR reporting unit and 30.2% of all reports to antibacterials. Type A reactions (58.8%) accounted for majority and more were described to be common (48.8%) in the literature. Levofloxacin (48.8%) occupied the major share of the reactions reported. Pattern of ADRs observed was comparable to that reported in literature. The organ system most commonly affected was skin and appendages (32.5%) and the most frequently reported reaction was skin rash (21.3%). Interestingly, no report of reactions affecting musculoskeletal system was observed while rare reaction like nephrotoxicity was noticed. The proportion of nervous system adverse reactions noticed were higher than that observed with antibacterial agents in general. Drug dechallenge was instituted in majority (73.8%) for management of the reactions, while additional treatment was instituted in 50% of the reactions. More of the reactions were probable (52.5%) in nature on causality assessment and were of moderate (72.5%) severity. Many (23.8%) of the reactions were deemed to be preventable on evaluation. Drug-drug and drug-disease interaction were the most important factors which contributed to preventability. Even though ADRs to fluoroquinolones are considered mainly to be mild in severity, our evaluation revealed considerable number of reactions of moderate severity. The present evaluation has revealed opportunities for interventions especially for the preventable ADRs which will help in promoting safer use of this important group of antibiotics. Cautious use of these agents especially in patients with predisposing factors and proper monitoring is warranted. Spontaneous reporting programs in spite of its limitations are useful in identifying pattern of ADRs in a hospital set up. Similar hospital based evaluation will provide valuable information which would help in promoting safe use of these medications. © 2008 - IOS Press and the authors. All rights reserved.

AB - Fluoroquinolones are one among the most commonly prescribed antibiotics in hospital set up. Only few published studies are available which tried to characterize the nature of ADRs to fluoroquinolones encountered in a hospital set up. The present study was aimed at analyzing the pattern of ADRs implicated to fluoroquinolone antibiotics reported spontaneously to the ADR reporting unit of a tertiary care teaching hospital in India. ADRs reported over a period of 4 years and 6 months were analyzed. Evaluation was done for patient demographics, drug and reaction characteristics, predisposing factors, and outcome of reactions. Analysis for causality, severity and preventability was also done. Eighty ADRs associated with fluoroquinolones were notified during the evaluation period, which accounted for 5.4% of the total ADRs reported in the ADR reporting unit and 30.2% of all reports to antibacterials. Type A reactions (58.8%) accounted for majority and more were described to be common (48.8%) in the literature. Levofloxacin (48.8%) occupied the major share of the reactions reported. Pattern of ADRs observed was comparable to that reported in literature. The organ system most commonly affected was skin and appendages (32.5%) and the most frequently reported reaction was skin rash (21.3%). Interestingly, no report of reactions affecting musculoskeletal system was observed while rare reaction like nephrotoxicity was noticed. The proportion of nervous system adverse reactions noticed were higher than that observed with antibacterial agents in general. Drug dechallenge was instituted in majority (73.8%) for management of the reactions, while additional treatment was instituted in 50% of the reactions. More of the reactions were probable (52.5%) in nature on causality assessment and were of moderate (72.5%) severity. Many (23.8%) of the reactions were deemed to be preventable on evaluation. Drug-drug and drug-disease interaction were the most important factors which contributed to preventability. Even though ADRs to fluoroquinolones are considered mainly to be mild in severity, our evaluation revealed considerable number of reactions of moderate severity. The present evaluation has revealed opportunities for interventions especially for the preventable ADRs which will help in promoting safer use of this important group of antibiotics. Cautious use of these agents especially in patients with predisposing factors and proper monitoring is warranted. Spontaneous reporting programs in spite of its limitations are useful in identifying pattern of ADRs in a hospital set up. Similar hospital based evaluation will provide valuable information which would help in promoting safe use of these medications. © 2008 - IOS Press and the authors. All rights reserved.

U2 - 10.3233/JRS-2008-0441

DO - 10.3233/JRS-2008-0441

M3 - Article

VL - 20

SP - 169

EP - 180

JO - International Journal of Risk and Safety in Medicine

JF - International Journal of Risk and Safety in Medicine

SN - 0924-6479

IS - 3

ER -