PMID- 35442845
OWN - NLM
STAT- MEDLINE
DCOM- 20220706
LR  - 20220706
IS  - 1758-1125 (Electronic)
IS  - 0268-3555 (Linking)
VI  - 37
IP  - 6
DP  - 2022 Jul
TI  - Analysis of adverse events with sclerosants reported to the United States Food 
      and Drug Administration.
PG  - 452-459
LID - 10.1177/02683555221088373 [doi]
AB  - OBJECTIVES: To analyze adverse events (AEs) related to sclerosants reported 
      through the Federal Adverse Event Reporting System (FAERS). METHODS: We queried 
      the FAERS database for all cases associated with sclerosants. Reports were 
      analyzed and stratified based on severity of cases and patient death. RESULTS: A 
      total of 1215 cases with 3124 reactions were identified among 4 sclerosants. 
      "General disorder and administration site conditions" reaction group was 
      prevalent in all sclerosants. For polidocanol, deep vein thrombosis and pulmonary 
      embolism were the most common severe reactions while cardiac arrest was frequent 
      in death cases. Anaphylaxis was common in fatalities of sodium tetradecyl 
      sulfate. Ethanolamine oleate was associated with procedural errors, while 
      morrhuate sodium resulted in few cases. CONCLUSION: Our analysis supports 
      previous studies concerning common local symptoms, but also reveals serious and 
      death associated reaction profiles specific to individual sclerosants. 
      Practitioners should be knowledgeable on both non-lethal and fatal AEs for each 
      sclerosant. The multitude of reports concerning serious reactions and deaths we 
      report herein provide a cautionary reminder to venous practitioners and patients 
      that sclerotherapy is not a trivial procedure.
FAU - Nguyen, Christopher N
AU  - Nguyen CN
AUID- ORCID: 0000-0002-1743-445X
AD  - School of Medicine, 3989Baylor College of Medicine, Houston, TX, USA.
FAU - Nguyen, Quoc-Bao D
AU  - Nguyen QD
AD  - Department of Dermatology, 4002The University of Texas MD Anderson Cancer Center, 
      Houston, TX, USA.
AD  - Department of Dermatology, 12339UTHealth McGovern Medical School, Houston, TX, 
      USA.
FAU - Silapunt, Sirunya
AU  - Silapunt S
AD  - Department of Dermatology, 12339UTHealth McGovern Medical School, Houston, TX, 
      USA.
LA  - eng
PT  - Journal Article
DEP - 20220420
PL  - England
TA  - Phlebology
JT  - Phlebology
JID - 9012921
RN  - 0 (Sclerosing Solutions)
RN  - 0AWH8BFG9A (Polidocanol)
RN  - Q1SUG5KBD6 (Sodium Tetradecyl Sulfate)
SB  - IM
MH  - Humans
MH  - Polidocanol/adverse effects
MH  - *Sclerosing Solutions
MH  - Sclerotherapy/adverse effects/methods
MH  - *Sodium Tetradecyl Sulfate
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - Adverse events
OT  - FAERS
OT  - complications
OT  - sclerosant
OT  - sclerotherapy
EDAT- 2022/04/21 06:00
MHDA- 2022/07/07 06:00
CRDT- 2022/04/20 17:12
PHST- 2022/04/21 06:00 [pubmed]
PHST- 2022/07/07 06:00 [medline]
PHST- 2022/04/20 17:12 [entrez]
AID - 10.1177/02683555221088373 [doi]
PST - ppublish
SO  - Phlebology. 2022 Jul;37(6):452-459. doi: 10.1177/02683555221088373. Epub 2022 Apr 
      20.