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drug adverse effects of fluoroquinolones

Adverse effects: 1) hypoglycemia* (generally within 1st 3 days) [9,25] 2) hyperglycemia (generally after 3 days) [9] 3) tendonitis & tendon rupture, esp Achilles tendon rupture [2,3,6] - older age, lower BMI & glucocorticoid use increases risk [6] 4) QT prolongation [4] 5) retinal detachment [5] a) may occur within 5 days b) HR=4.5 [5]; RR=1.5; number needed to harm - 2500 [5] c) no increased risk with oral fluoroquinolones [11,19] 6) acute kidney injury (absolute risk is small) [7] - acute interstitial nephritis [23] 7) peripheral neuropathy from systemic fluoroquinolones - permanent nerve damage may occur [8,10] - oral fluoroquinolones are associated with a 1.5-2 fold increase in risk for polyneuropathy [12,28] - 1 additional case per 150,000 10-day fluoroquinolone courses [28] 8) oral fluoroquinolones are not associated with increased risk for serious arrhythmia, compared with penicillin [13] 9) central nervous system excitatory changes - seizures [17], hallucinations [16] 10) potentially permanent side effects of the tendons, muscles, joints, nerves, & central nervous system can occur together in the same patient [16] 11) 2-fold increased risk of miscarriage [18] 12) risk of aortic aneurysm vs amoxicillin - RR = 1.7, absolute risk = 0.0082%/treatment episode [24] - no increased risk of aortic aneurysm or aortic dissection [19] - risk for aortic aneurysm & aortic dissection (RR=2-3) [26] - risk is marginal at best [29] - risk of aortic aneurysm for adults > 35 years of age is 7.5 cases per 10,000 fills vs 4.6 per 10,000 fills for comparable antibiotic [30] 13) fluoroquinolones may exacerbate myasthenia gravis [20] 14) increased risk for pseudotumor cerebri 5-fold within 15 days of oral fluoroquinolone [21] 18) increased risk of carpal tunnel syndrome (RR=1.34) [22] 19) mental health issues [25] - agitation, inattention, delirium, disorientation, memory impairment, nervousness 20) hypersensitivity: cross-reactivity among fluoroquinolones uncommon [31] * may cause severe hypoglycemia when used in combination with sulfonylureas, repaglinide (Prandin) & other hypoglycemic agents * serious side effects generally outweigh the benefits for patients with sinusitis, bronchitis, & uncomplicated urinary tract infections [15]

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DRUGS: fluoroquinolone FORM: drug adverse effects fluoroquinolone

References

  1. Prescriber's Letter 13(1): 2006 Glucose abnormalities and fluoroquinolones Detail-Document#: 220109 (subscription needed) http://www.prescribersletter.com
  2. FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone
  3. Prescriber's Letter 15(8): 2008 Fluoroquinolones and Risk of Tendinitis and Tendon Rupture Detail-Document#: 240802 (subscription needed) http://www.prescribersletter.com
  4. Geriatric Review Syllabus, 7th edition Parada JT et al (eds) American Geriatrics Society, 2010
  5. Etminan M e al Oral Fluoroquinolones and the Risk of Retinal Detachment JAMA. 2012;307(13):1414-1419 PMID: 22474205 http://jama.ama-assn.org/content/307/13/1414.short
  6. Wise BL et al. Impact of age, sex, obesity, and steroid use on quinolone- associated tendon disorders. Am J Med 2012 Dec; 125:1228.e23. PMID: 23026288
  7. Bird ST et al. Risk of acute kidney injury associated with the use of fluoroquinolones. CMAJ 2013 Jul 9; 185:E475 PMID: 23734036 http://www.cmaj.ca/content/185/10/E475?ijkey=719ce2e015f88fb295f33da8cfe395060fb60430&keytype2=tf_ipsecsha
  8. FDA MedWatch. August 15, 2013 Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm365302.htm
  9. Chou HW et al Risk of Severe Dysglycemia Among Diabetic Patients Receiving Levofloxacin, Ciprofloxacin, or Moxifloxacin in Taiwan. Clin Infect Dis. August 14, 2013 PMID: 23948133 http://cid.oxfordjournals.org/content/early/2013/07/23/cid.cit439.abstract
  10. Prescriber's Letter 20(10): 2013 Adverse Reactions with Systemic Quinolones Detail-Document#: 291004 (subscription needed) http://www.prescribersletter.com
  11. Pasternak B et al Association Between Oral Fluoroquinolone Use and Retinal Detachment. JAMA. 2013;310(20):2184-2190. PMID: 24281462 http://jama.jamanetwork.com/article.aspx?articleid=1785461 - Brett AS Oral Fluoroquinolone Use and Retinal Detachment Reconciling Conflicting Findings in Observational Research. JAMA. 2013;310(20):2151-2153 PMID: 24281459 http://jama.jamanetwork.com/article.aspx?articleid=1785435
  12. Etminan M et al. Oral fluoroquinolone use and risk of peripheral neuropathy: A pharmacoepidemiologic study. Neurology 2014 Aug 22 PMID: 25150290
  13. Inghammar M et al Oral fluoroquinolone use and serious arrhythmia: bi-national cohort study. BMJ 2016;352:i843 PMID: 26920666 http://www.bmj.com/content/352/bmj.i843
  14. Raguideau F et al. Association between oral fluoroquinolone use and retinal detachment. JAMA Ophthalmol 2016 Apr; 134:415 PMID: 26967005
  15. FDA Safety Watch. May 12, 2016 Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500665.htm
  16. FDA Safety Communication. July 26, 2016 Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm513065.htm
  17. Medications Can Cause Seizures Prescriber's Letter 10(3):16 2003 Detail-Document#: 190320 (subscription needed) http://www.prescribersletter.com
  18. Muanda FT, Sheehy O, Berard A Use of antibiotics during pregnancy and risk of spontaneous abortion. CMAJ 2017 May 1;189:E625-33 PMID: 28461374 http://www.cmaj.ca/content/189/17/E625.full.pdf+html
  19. Brooks M FDA: Fluoroquinolones Not Linked to Retinal Detachment Medscape - May 11, 2017 http://www.medscape.com/viewarticle/879889 - FDA Drug Safety Communication. May 12, 2017 FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm
  20. Lowes R FDA Approves Delafloxacin (Baxdela) for Skin Infections Medscape - Jun 19, 2017. http://www.medscape.com/viewarticle/881827
  21. Sodhi M, Sheldon CA, Carleton B, Etminan M. Oral fluoroquinolones and risk of secondary pseudotumor cerebri syndrome: Nested case-control study. Neurology 2017 Jul 28 PMID: 28754842 http://www.neurology.org/content/89/8/792
  22. Cheng JZ, Sodhi M, Etminan M, Carleton BC. Fluoroquinolone Use and Risk of Carpal Tunnel Syndrome: A Pharmacoepidemiologic Study. Clin Infect Dis. 2017 Apr 24. PMID: 28444196
  23. Farid S, Mahmood M, Abu Saleh OM et al. Clinical manifestations and outcomes of fluoroquinolone- related acute interstitial nephritis. Mayo Clin Proc. 2018 Jan;93(1):25-31 PMID: 29157532 http://www.mayoclinicproceedings.org/article/S0025-6196(17)30695-X/fulltext
  24. Pasternak B, Inghammar M, Svanstrom H. Fluoroquinolone use and risk of aortic aneurysm and dissection: nationwide cohort study BMJ 2018;360:k678 http://www.bmj.com/content/360/bmj.k678
  25. FDA Safety Alert. July 10, 2018 Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm - FDA News Release, July 10, 2018 FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612995.htm
  26. Walker M FDA Warns on Aortic Aneurysms With Fluoroquinolones. Adds to already long list of issues with popular antibiotic class. MedPage Today. Dec 20, 2018 https://www.medpagetoday.com/publichealthpolicy/fdageneral/77060 - FDA Safety Alert. Dec 20, 2018 Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm628960.htm
  27. Lewis T, Cook J. Fluoroquinolones and tendinopathy: a guide for athletes and sports clinicians and a systematic review of the literature. J Athl Train. 2014 May-Jun;49(3):422-7. Review. PMID: 24762232 Free PMC Article
  28. Morales D, Pacurariu A, Slattery J et al. Association between peripheral neuropathy and exposure to oral fluoroquinolone or amoxicillin-clavulanate therapy. JAMA Neurol 2019 Jul; 76:827 PMID: 31034074 https://jamanetwork.com/journals/jamaneurology/fullarticle/2731583
  29. Gopalakrishnan C et al. Association of fluoroquinolones with the risk of aortic aneurysm or aortic dissection. JAMA Intern Med 2020 Sep 8; [e-pub] PMID: 32897307 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2770379 - Dong Y-H et al. Association of infections and use of fluoroquinolones with the risk of aortic aneurysm or aortic dissection. JAMA Intern Med 2020 Sep 8; [e-pub]. PMID: 32897358 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2770378
  30. Newton ER, Akerman AW, Strassle PD et al Association of Fluoroquinolone Use With Short-term Risk of Development of Aortic Aneurysm. JAMA Surg. Published online January 6, 2021 PMID: 33404647 https://jamanetwork.com/journals/jamasurgery/fullarticle/2774747
  31. Shah S et al. In-class cross-reactivity among hospitalized patients with hypersensitivity reactions to fluoroquinolones. Antimicrob Agents Chemother 2023 May 8; [e-pub]. PMID: 37154772 https://journals.asm.org/doi/10.1128/aac.00374-23 - Adams KK, Shah S. Health system evaluation of fluoroquinolone hypersensitivity: An assessment of cross-reactivity. J Antimicrob Chemother 2023 May 10; [e-pub] PMID: 37161664 https://academic.oup.com/jac/advance-article-abstract/doi/10.1093/jac/dkad136/7158810