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Signal detection of botulinum toxin type A (BoNT/A) using the Korea Adverse Event Reporting System Database,
Insights
Adverse event reports for botulinum toxin (BTX) have increased, particularly in females. Safety signals like "medicine ineffective" suggest potential off-label use requiring surveillance.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Medical Informatics
Background:
- Botulinum toxin (BTX) is widely used for cosmetic and therapeutic purposes.
- Monitoring adverse events (AEs) is crucial for patient safety.
- The Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD) collects AEs.
Purpose of the Study:
- To detect potential safety signals of AEs following BTX treatment.
- To analyze AE reports submitted to the KIDS-KD database from 1999 to 2016.
- To compare detected safety signals with existing drug labels.
Main Methods:
- Analysis of 5,896 AE reports from the KIDS-KD database (1999-2016).
- Disproportionality analysis using proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC).
- Comparison of identified safety signals with US and Korean BTX drug labels.
Main Results:
- 1,413 out of 103,785 drug-AE pairs were attributed to BTX.
- Disproportionality analysis identified 44 preferred terms (PTs) as safety signals.
- Seven unlabeled PTs were detected, including "medicine ineffective" and "depression" with adjusted RORs of 21.60 and 6.02, respectively.
Conclusions:
- AE reports for BTX have increased, predominantly from female patients.
- Identified safety signals, such as "medicine ineffective" and "concentration impaired," may indicate off-label use.
- Long-term surveillance is recommended, especially for female patients receiving BTX injections.
Objective:
To detect signals of potential adverse events (AEs) after botulinum toxin (BTX) treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD).
Materials And Methods:
The individual case safety reports (ICSRs) submitted to KIDS-KD from 1999 to 2016 were analyzed. To detect safety signals, disproportionality analysis was introduced, and the three indices (proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC)) were calculated based on the reported preferred terms (WHO-ART, preferred term (PT)). The signals detected were compared with drug labels from Korea and the USA.
Results:
A total of 5,896 AE reports were collected in January 1999 - December 2016 in the Korea Adverse Event Reporting System (KAERS) databases. Among the total of 103,785 drug-AE pairs, 1,413 were attributed to BTX. The disproportionality analysis produced 44 PTs as safety signals and detected 7 unlabeled PTs that were not listed on the labels. After matching for age and sex (1 : 2), the adjusted ROR of ineffective medicine and depression in BTX was 21.60 (95% confidence interval (CI), 19.12 - 24.41) and 6.02 (95% CI, 3.41 - 10.64) respectively.
Conclusion:
The number of AE reports after BTX has increased, the majority of which were from females. Safety signals such as "medicine ineffective" and "concentration impaired" may be due to increasing off-label use, which warrants long-term surveillance, especially among females after BTX injection.
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