PMID- 33480840
OWN - NLM
STAT- MEDLINE
DCOM- 20210617
LR  - 20210617
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 59
IP  - 5
DP  - 2021 May
TI  - Signal detection of botulinum toxin type A (BoNT/A) using the Korea Adverse Event 
      Reporting System Database, 1999 - 2016.
PG  - 386-397
LID - 10.5414/CP203776 [doi]
AB  - 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.
FAU - Lee, Sang-Eun
AU  - Lee SE
FAU - Lee, Seon Hee
AU  - Lee SH
FAU - Shin, Ju-Young
AU  - Shin JY
LA  - eng
PT  - Journal Article
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Botulinum Toxins, Type A/adverse effects
MH  - Databases, Factual
MH  - *Drug-Related Side Effects and Adverse Reactions/diagnosis/epidemiology
MH  - Female
MH  - Humans
MH  - Odds Ratio
MH  - Republic of Korea
EDAT- 2021/01/23 06:00
MHDA- 2021/06/22 06:00
CRDT- 2021/01/22 12:14
PHST- 2021/04/14 00:00 [accepted]
PHST- 2021/01/23 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2021/01/22 12:14 [entrez]
AID - 187636 [pii]
AID - 10.5414/CP203776 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2021 May;59(5):386-397. doi: 10.5414/CP203776.