Botulinum Toxin Type A Overdoses: Analysis of the FDA Adverse Event Reporting System Database.

Botulinum Toxin Type A Overdoses: Analysis of the FDA Adverse Event Reporting System Database.

Kazerooni, Rashid;Armstrong, Edward P;
Clinical drug investigation 2018 Vol. 38 pp. 867-872
379
kazerooni2018botulinumclinical

Abstract

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.

Citation

ID: 50212
Ref Key: kazerooni2018botulinumclinical
Use this key to autocite in SciMatic or Thesis Manager

References

Blockchain Verification

Account:
NFT Contract Address:
0x95644003c57E6F55A65596E3D9Eac6813e3566dA
Article ID:
50212
Unique Identifier:
10.1007/s40261-018-0668-7
Network:
Scimatic Chain (ID: 481)
Loading...
Blockchain Readiness Checklist
Authors
Abstract
Journal Name
Year
Title
5/5
Creates 1,000,000 NFT tokens for this article
Token Features:
  • ERC-1155 Standard NFT
  • 1 Million Supply per Article
  • Transferable via MetaMask
  • Permanent Blockchain Record
Blockchain QR Code
Scan with Saymatik Web3.0 Wallet

Saymatik Web3.0 Wallet