Botulinum Toxin Type A Overdoses: Analysis of the FDA Adverse Event Reporting System Database
- 158 Downloads
Published literature on overdoses related to botulinum toxin A (BtxA) agents is scarce.
The aim of this study was to assess the BtxA drug class’ respective agents for associations with overdose.
United States Food and Drug Administration (FDA) adverse event reporting system (FAERS) database was utilized to search for overdoses. The analysis was conducted on data between second quarter 2014 and third quarter 2017. BtxA cases were included when they were considered the “Primary Suspect” drug. Overdose was defined as presence of ‘overdose’ being reported as an adverse event. Primary outcome was incidence of ‘overdose’ compared within the respective agents. Additionally, a disproportionality analysis was conducted utilizing reporting odds ratio (ROR) versus onabotulinumtoxinA as a referent while controlling for confounding variables.
A total of 3,837,406 unique adverse events were reported during the study period for all drugs in the FAERS database. Of which, 13,078 were BtxA cases. The rate of adverse events involving overdose for abobotulinumtoxinA (20.2%; 215/1065) was significantly higher than both onabotulinumtoxinA (0.4%; 48/11,323; p < 0.0001) and incobotulinumtoxinA (0.1%; 1/690; p < 0.0001). In the regression analysis, abobotulinumtoxinA (ROR 73.26; 95% CI 51.17–104.90) had a significant association with overdose, whereas incobotulinumtoxinA (ROR 0.73; 95% CI 0.10–5.36) did not, versus the referent onabotulinumtoxinA.
The present analysis showed adverse events of abobotulinumtoxinA were significantly associated with overdose versus the other two BtxA agents. Overdose can be difficult to research, particularly for in-clinic administered drugs. Future studies should venture to confirm these results in new and novel ways.
Compliance with ethical standards
Conflict of interest
Dr. Rashid Kazerooni conducted this analysis as part of an independent graduate research project with the University of Wyoming. Dr Kazerooni was also an employee of Merz North America, Inc. at the time this analysis was conducted. Dr. Kazerooni’s graduate program was partially funded by Merz North America, Inc. via a tuition reimbursement employee benefit program. The comments in the manuscript do not necessarily reflect the views of Merz North America, Inc. Dr. Edward P. Armstrong has nothing to disclose.
The present study was not funded by extramural sources.
- 3.Allergan, Inc. Botox® (onabotulinumtoxinA) prescribing information. 2018. https://www.allergan.com/assets/pdf/botox_pi.pdf. Accessed 10 Mar 2018.
- 4.Allergan, Inc. Botox Cosmetic® (onabotulinumtoxinA) prescribing information. 2018. https://www.allergan.com/assets/pdf/botox_cosmetic_pi.pdf. Accessed 10 Mar 2018.
- 5.Ipsen Biopharm Ltd. Dysport® (abobotulinumtoxinA) prescribing information. 2018. https://www.dysport.com/docs/pdfs/Dysport_Full_Prescribing_Information.pdf. Accessed 10 Mar 2018.
- 6.Merz North America, Inc. Xeomin® (incobotulinumtoxinA) prescribing information. 2018. http://www.xeomin.com/wp-content/uploads/xeomin-full-prescribing-information.pdf. Accessed 10 Mar 2018.
- 8.US Food and Drug Administration (FDA). 2018. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm. Accessed 10 Mar 2018.
- 10.US FDA. FDA adverse event reporting system (FAERS): Latest quarterly data files. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm. Accessed 10 Mar 2018.
- 11.MedDRA. https://www.meddra.org/. Accessed 10 Mar 2018.
- 22.Kane MA, Gold MH, Coleman WP 3rd, Jones DH, Tanghetti EA, Alster TS, Rohrer TE, Burgess CM, Shamban AT, Finn E. A Randomized, double-blind trial to investigate the equivalence of incobotulinumtoxinA and onabotulinumtoxinA for glabellar frown lines. Dermatol Surg. 2015;41(11):1310–9.CrossRefGoogle Scholar
- 23.Sattler G, Callander MJ, Grablowitz D, Walker T, Bee EK, Rzany B, Flynn TC, Carruthers A. Noninferiority of incobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabellar frown lines. Dermatol Surg. 2010;36(Suppl 4):2146–54.CrossRefGoogle Scholar
- 27.Weber J. Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. Adv Inflamm Res. 1984;6:1–7.Google Scholar
- 30.Allergan press release. 2018. https://www.allergan.com/news/news/thomson-reuters/allergan-reports-solid-finish-to-2017. Accessed 5 Jun 2018.
- 31.US FDA. FDA adverse event reporting system (FAERS) public dashboard. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm. Accessed 10 Mar 2018.