Peripheral neuropathy and Guillain-Barré syndrome risks associated with exposure to systemic fluoroquinolones: A pharmacovigilance analysis

Annals of Epidemiology

Volumn 24, Issue 4, 2014, Pages 279-285

  Ali, Ayad K ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Disproportionality analysis; FAERS; Fluoroquinolones; Guillain Barr syndrome; Peripheral neuropathy; Pharmacovigilance

Indexed keywords

AMOXICILLIN; AZITHROMYCIN; CIPROFLOXACIN; CLINDAMYCIN; CLOXAN; COTRIMOXAZOLE; ERYTHROMYCIN; LEVOFLOXACIN; LINEZOLID; METRONIDAZOLE; MOXIFLOXACIN; NITROFURANTOIN; NORFLOXACIN; OFLOXACIN; QUINOLONE DERIVATIVE; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CONTROLLED STUDY; DISEASE ASSOCIATION; DISPROPORTIONALITY ANALYSIS; DRUG EXPOSURE; DRUG FATALITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EMPIRICAL BAYES GEOMETRIC MEAN; FEMALE; FOOD AND DRUG ADMINISTRATION; GUILLAIN BARRE SYNDROME; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES; MIDDLE AGED; PERIPHERAL NEUROPATHY; PHYSICAL DISABILITY; PRIORITY JOURNAL; RISK ASSESSMENT; RISK FACTOR; SIGNAL DETECTION; STATISTICAL ANALYSIS; STATISTICAL CONCEPTS; UNSPECIFIED SIDE EFFECT; VERY ELDERLY;

DISPROPORTIONALITY ANALYSIS; FAERS; FLUOROQUINOLONES; GUILLAIN-BARRÉ SYNDROME; PERIPHERAL NEUROPATHY; PHARMACOVIGILANCE;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CHILD; CONFIDENCE INTERVALS; DATABASES, FACTUAL; FEMALE; FLUOROQUINOLONES; GUILLAIN-BARRE SYNDROME; HUMANS; MALE; MIDDLE AGED; PERIPHERAL NERVOUS SYSTEM DISEASES; PHARMACOVIGILANCE; RISK ASSESSMENT; UNITED STATES; YOUNG ADULT;

EID: 84895455991     PISSN: 10472797     EISSN: 18732585     Source Type: Journal    
DOI: 10.1016/j.annepidem.2013.12.009     Document Type: Article

References (23)

1. Food and Drug Administration. Ciprofloxacin label revision letter. 14 July 2004. [accessed 29 August 2013]. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo.
2. Food and Drug Administration. Levofloxacin label revision letter. 14 September 2004. [accessed 29 August 2013]. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf.
3. Food and Drug Administration. Moxifloxacin label revision letter. 28 July 2004. [accessed 29 August 2013]. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo.
4. Food and Drug Administration. Norfloxacin label revision letter. 23 July 2004. [accessed 29 August 2013]. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo.
5. Food and Drug Administration. Ofloxacin label revision letter. 15 September 2004. [accessed 29 August 2013]. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo.
6. Food and Drug Administration. FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection. 15 August 2013. [accessed 15 August 2013]. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM365078.%20pdf.
7. Laughlin R.S., Dyck P.J., Melton L.J., Leibson C., Ransom J., Dyck P.J.B. Incidence and prevalence of CIDP and the association of diabetes mellitus. Neurology 2009, 73(1):39-45.
8. Azhary H., Farooq M.U., Bhunushali M., Majid A., Kassab M.Y. Peripheral neuropathy: differential diagnosis and management. Am Fam Physician 2010, 81(7):887-892.
9. Cheng Y.J., Gregg E.W., Kahn H.S., Williams D.E., DeRekeneire N., Narayan K.M. Peripheral insensate neuropathy-a tall problem for US adults?. Am J Epidemiol 2006, 164(9):873-880.
10. National Institute of Neurological Disorders and Stroke. Peripheral neuropathy fact sheet. Updated 19 September 2012. [accessed 4 September 2013]. http://www.ninds.nih.gov/disorders/peripheralneuropathy/detail_peripheralneuropathy.htm.
11. Ali A.K. Pharmacovigilance analysis of adverse event reports for aliskiren hemifumarate, a first-in-class direct renin inhibitor. Ther Clin Risk Manag 2011, 7:337-344.
12. Wysowski D.K., Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Intern Med 2005, 165(12):1363-1369.
13. Rodriguez E.M., Staffa J.A., Graham D.J. The role of databases in drug postmarketing surveillance. Pharmacoepidemiol Drug Saf 2001, 10(5):407-410.
14. Ali A.K., Hartzema A.G. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting. JAsthma Alelrgy 2012, 5:1-9.
15. Harpaz R., DuMouchel W., Shah N.H., Madigan D., Ryan P., Friedman C. Novel data-mining methodologies for adverse drug event discovery and analysis. Clin Pharmacol Ther 2012, 91(6):1010-1021.
16. Almenoff J.S., Pattishall E.N., Gibbs T.G., DuMouchel W., Evans S.J., Yuen N. Novel statistical tools for monitoring the safety of marketed drugs. Clin Pharmacol Ther 2007, 82(2):157-166.
17. Sakaeda T., Tamon A., Kadoyama K., Okuno Y. Data mining of the public version of the FDA Adverse Event Reporting System. Int J Med Sci 2013, 10(7):796-803.
18. DuMouchel W. Bayesian data mining in large frequency tables, with anapplication to the FDA Spontaneous Reporting System. Am Stat 1999, 53(3):177-190.
19. Harpaz R., DuMouchel W., LePendu P., Bauer-Mehren A., Ryan P., Shah N.H. Performance of pharmacovigilance signal-detection algorithms for theFDA adverse event reporting system. Clin Pharmacol Ther 2013, 93(6):539-546.
20. Ali A.K. Pharmacovigilance analysis of adverse psychiatric events and suicidality reported for roflumilast, an add-on COPD therapy. Br J Pharm Res 2013, 3(4):972-982.
21. Srba J., Descikova V., Vlcek J. Adverse drug reactions: analysis of spontaneous reporting system in Europe in 2007-2009. Eur J Clin Pharmacol 2012, 68(7):1057-1063.
22. Wang H.W., Hochberg A.M., Pearson R.K., Hauben M. An experimental investigation of masking in the US FDA adverse event reporting system database. Drug saf 2010, 33(12):1117-1133.
23. Martyn C.N., Hughes R.A.C. Epidemiology of peripheral neuropathy. JNeurol Neurosurg Psychiatry 1997, 62(4):310-318.