PMID- 35475524
OWN - NLM
STAT- MEDLINE
DCOM- 20220803
LR  - 20221005
IS  - 1346-8138 (Electronic)
IS  - 0385-2407 (Print)
IS  - 0385-2407 (Linking)
VI  - 49
IP  - 8
DP  - 2022 Aug
TI  - Severe cutaneous adverse reactions associated with systemic ivermectin: A 
      pharmacovigilance analysis.
PG  - 769-774
LID - 10.1111/1346-8138.16398 [doi]
AB  - Despite poor evidence, the antiparasitic ivermectin has been advocated as a 
      potential COVID-19 therapy. This has led to a rise in calls to poison-control 
      centers by people self-medicating with ivermectin, which is sold over the counter 
      for veterinary uses. We aimed to investigate the association between severe 
      cutaneous adverse reactions (SCARs) and ivermectin. Postmarketing data from the 
      FDA Adverse Event Reporting System (FAERS), gathered between 2014 and 2021, was 
      employed to detect disproportional signals of SCARs following systemic ivermectin 
      therapy. The reporting odds ratio (ROR) was used to quantify the strength of 
      association, while adjusting for age, sex, and region. The search yielded 517 
      reports of systemic ivermectin (median age 54 years, 46.8% female), of which 25 
      (4.8%), 81 (15.7%), and 411 (79.5%) were classified as SCARs, nonsevere cutaneous 
      adverse events (AEs), or noncutaneous AEs, respectively. The regional 
      distribution differed between SCAR reports (32.0% from Africa and 12.0% from 
      North America) compared with other AEs, which originated from North America in 
      over half of cases. The most common SCARs were toxic epidermal necrolysis (seven 
      cases), Stevens-Johnson syndrome (seven cases), and drug reaction with 
      eosinophilia and systemic symptoms (four cases). Five SCAR cases (20.0%) resulted 
      in death and 12 (48.0%) lead to hospitalization. There was a strong safety signal 
      for any SCAR (adjusted ROR 3.34, 95% confidence interval [CI] 2.17-5.12) and 
      toxidermias (adjusted ROR 7.08, 95% CI 4.23-11.84). This study suggests that 
      ivermectin is associated with SCARs on rare occasions. Dermatologists should be 
      aware of this given the increase in ivermectin misuse.
CI  - (c) 2022 The Authors. The Journal of Dermatology published by John Wiley & Sons 
      Australia, Ltd on behalf of Japanese Dermatological Association.
FAU - Bomze, David
AU  - Bomze D
AUID- ORCID: 0000-0003-2958-7055
AD  - Division of Dermatology, Tel Aviv Sourasky Medical Center and Sackler Faculty of 
      Medicine, Tel Aviv, Israel.
FAU - Sprecher, Eli
AU  - Sprecher E
AD  - Division of Dermatology, Tel Aviv Sourasky Medical Center and Sackler Faculty of 
      Medicine, Tel Aviv, Israel.
FAU - Geller, Shamir
AU  - Geller S
AUID- ORCID: 0000-0003-1206-1057
AD  - Division of Dermatology, Tel Aviv Sourasky Medical Center and Sackler Faculty of 
      Medicine, Tel Aviv, Israel.
LA  - eng
PT  - Journal Article
DEP - 20220427
PL  - England
TA  - J Dermatol
JT  - The Journal of dermatology
JID - 7600545
RN  - 70288-86-7 (Ivermectin)
SB  - IM
MH  - *COVID-19
MH  - Cicatrix
MH  - Female
MH  - Humans
MH  - Ivermectin/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Pharmacovigilance
MH  - *Stevens-Johnson Syndrome
PMC - PMC9111106
OTO - NOTNLM
OT  - FDA adverse event reporting system
OT  - Stevens-Johnson syndrome
OT  - ivermectin
OT  - severe cutaneous adverse event
OT  - toxic epidermal necrolysis
COIS- The authors report no conflict of interest.
EDAT- 2022/04/28 06:00
MHDA- 2022/08/04 06:00
PMCR- 2022/04/27
CRDT- 2022/04/27 08:42
PHST- 2022/03/27 00:00 [revised]
PHST- 2021/12/18 00:00 [received]
PHST- 2022/03/29 00:00 [accepted]
PHST- 2022/04/28 06:00 [pubmed]
PHST- 2022/08/04 06:00 [medline]
PHST- 2022/04/27 08:42 [entrez]
PHST- 2022/04/27 00:00 [pmc-release]
AID - JDE16398 [pii]
AID - 10.1111/1346-8138.16398 [doi]
PST - ppublish
SO  - J Dermatol. 2022 Aug;49(8):769-774. doi: 10.1111/1346-8138.16398. Epub 2022 Apr 
      27.