Disclosures: Rashid Kazerooni, PharmD, MS, BCPS: Merz North America (Products/Services: Yes) (Employment)

Objective: A previously published study showed a 73-fold higher relative odds ratio for overdose with abobotulinumtoxinA versus other botulinum toxin A (BoNT-A) agents. The present analysis has two additional years of data included since the original analysis and additionally will explore for association with medication errors.

Design: BoNT-A cases were included when they were considered the “Primary Suspect” drug. Overdose was defined as incidence of ‘Overdose’ being reported as an adverse event. Setting : The Food and Drug Administration adverse event reporting system (FAERS) was utilized. Participants : The analysis was conducted on data between March 2014 and June 2019.

Interventions: N/A

Main Outcome Measures: The primary outcome was relative rate of ‘Overdose’ compared within the respective agents. This relative rate methodology utilized is a validated methodology for analyzing pharmacovigilance databases. Rates of overdose having a concomitant medication error were also reported. Medication error was defined as having a concomitant report of ‘Product preparation error’ and/or ‘Wrong technique in product usage process’. These two terms are classified as “Medication errors” within the Medical Dictionary for Regulatory Activities system.

Results: A total of 6,432,493 unique adverse events were reported during the study period for all drugs in the FAERS database. Of which, 23,789 were BoNT-A cases. The rate of adverse events involving overdose for abobotulinumtoxinA (14.2%; 342/2,415) was significantly higher than both onabotulinumtoxinA (0.4%; 78/20,113; p < 0.0001) and incobotulinumtoxinA ( < 0.1%; 1/1,261; p < 0.0001). Additionally, a large percentage of abobotulinumtoxinA overdoses (37.1%; 127/342) had concomitant report of a medication error. This phenomenon was not seen with onabotulinumtoxinA (1.3%; 1/78) or incobotulinumtoxinA (0.0%; 0/1) overdoses. Conclusions: The analysis validates earlier findings which showed abobotulinumtoxinA adverse events were significantly associated with overdose versus other BoNT-A agents. Furthermore, the present analysis showed abobotulinumtoxinA overdoses were often associated with medication errors. Future studies should venture to confirm these results.

Level of Evidence: Level III

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/botulinum-toxin-type-a-overdoses-and-associations-with-medication-errors/