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Antimicrobial safety: focus on fluoroquinolones.
Clin Infect Dis. 2005 Jul 15; 41 Suppl 2:S144-57.CI

Abstract

BACKGROUND/PURPOSE

Infrequent toxicities associated with certain drugs and drug classes have recently gained much attention from different health-care perspectives. To protect the patient, continued surveillance of safety and tolerability data is essential. Data from preclinical testing, phase 1-3 trials, and postmarketing surveillance may be used to objectively assess the risks associated with a specific drug or family of compounds. This review summarizes safety and tolerability data for the quinolones.

MAIN FINDINGS

The most common adverse events associated with the quinolone class involve the gastrointestinal tract (nausea and diarrhea) and central nervous system (CNS) (headache and dizziness). These adverse events are usually mild and do not require discontinuation of therapy. Uncommon and potentially serious quinolone-related adverse events involve the cardiovascular system (rate-corrected electrocardiographic QT interval prolongation), musculoskeletal system (tendinitis and tendon rupture), endocrine system (glucose homeostasis dysregulation), renal system (crystalluria, interstitial nephritis, and acute renal failure), and the CNS (seizures). Severe idiosyncratic adverse events are specific to individual agents that may share some structural congruity, such as the 1-(2,4)-difluorophenyl group shared by trovafloxacin (associated with hepatitis), temafloxacin (associated with hemolytic-uremic syndrome), and tosufloxacin (associated with eosinophilic pneumonitis). Overall, discontinuation rates from clinical trials were <4% for the currently marketed quinolones. Quinolones with higher discontinuation rates, such as trovafloxacin (7.0%) and grepafloxacin (6.4%), are no longer available for general use.

CONCLUSIONS

The currently marketed quinolones are well tolerated, with safety profiles similar to those of other antimicrobial classes. Although adverse effects are unusual, some, including tendinitis and CNS-related effects, are more common with quinolones than with other antimicrobial classes. Rare adverse effects attributed to some members of the quinolone family (e.g., Torsades de Pointes, hepatotoxicity, and dysglycemias) are more likely to occur in select "susceptible" populations. These adverse events can often be circumvented by avoiding exposure to the specific quinolone. In some cases, the therapeutic value offered by a quinolone may outweigh its potential risks.

Authors+Show Affiliations

Division of Infectious Diseases, Department of Clinical Pharmacy Services, Maine Medical Center, Portland, Maine 04102, USA. Owensr@mmc.orgNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

15942881

Citation

Owens, Robert C., and Paul G. Ambrose. "Antimicrobial Safety: Focus On Fluoroquinolones." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 41 Suppl 2, 2005, pp. S144-57.
Owens RC, Ambrose PG. Antimicrobial safety: focus on fluoroquinolones. Clin Infect Dis. 2005;41 Suppl 2:S144-57.
Owens, R. C., & Ambrose, P. G. (2005). Antimicrobial safety: focus on fluoroquinolones. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 41 Suppl 2, S144-57.
Owens RC, Ambrose PG. Antimicrobial Safety: Focus On Fluoroquinolones. Clin Infect Dis. 2005 Jul 15;41 Suppl 2:S144-57. PubMed PMID: 15942881.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antimicrobial safety: focus on fluoroquinolones. AU - Owens,Robert C,Jr AU - Ambrose,Paul G, PY - 2005/6/9/pubmed PY - 2006/9/19/medline PY - 2005/6/9/entrez SP - S144 EP - 57 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 41 Suppl 2 N2 - BACKGROUND/PURPOSE: Infrequent toxicities associated with certain drugs and drug classes have recently gained much attention from different health-care perspectives. To protect the patient, continued surveillance of safety and tolerability data is essential. Data from preclinical testing, phase 1-3 trials, and postmarketing surveillance may be used to objectively assess the risks associated with a specific drug or family of compounds. This review summarizes safety and tolerability data for the quinolones. MAIN FINDINGS: The most common adverse events associated with the quinolone class involve the gastrointestinal tract (nausea and diarrhea) and central nervous system (CNS) (headache and dizziness). These adverse events are usually mild and do not require discontinuation of therapy. Uncommon and potentially serious quinolone-related adverse events involve the cardiovascular system (rate-corrected electrocardiographic QT interval prolongation), musculoskeletal system (tendinitis and tendon rupture), endocrine system (glucose homeostasis dysregulation), renal system (crystalluria, interstitial nephritis, and acute renal failure), and the CNS (seizures). Severe idiosyncratic adverse events are specific to individual agents that may share some structural congruity, such as the 1-(2,4)-difluorophenyl group shared by trovafloxacin (associated with hepatitis), temafloxacin (associated with hemolytic-uremic syndrome), and tosufloxacin (associated with eosinophilic pneumonitis). Overall, discontinuation rates from clinical trials were <4% for the currently marketed quinolones. Quinolones with higher discontinuation rates, such as trovafloxacin (7.0%) and grepafloxacin (6.4%), are no longer available for general use. CONCLUSIONS: The currently marketed quinolones are well tolerated, with safety profiles similar to those of other antimicrobial classes. Although adverse effects are unusual, some, including tendinitis and CNS-related effects, are more common with quinolones than with other antimicrobial classes. Rare adverse effects attributed to some members of the quinolone family (e.g., Torsades de Pointes, hepatotoxicity, and dysglycemias) are more likely to occur in select "susceptible" populations. These adverse events can often be circumvented by avoiding exposure to the specific quinolone. In some cases, the therapeutic value offered by a quinolone may outweigh its potential risks. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/15942881/Antimicrobial_safety:_focus_on_fluoroquinolones_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1086/428055 DB - PRIME DP - Unbound Medicine ER -