Analysis of adverse events with sclerosants reported to the United States Food and Drug Administration

Abstract

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.

Sclerotherapy of lower limb veins: Indications, contraindications and treatment strategies to prevent complications – A consensus document of the International Union of Phlebology-2023

“…By contrast, no cases of VTE or death from VTE with the use of STS were reported to this database. 13 The total number of procedures performed in this time period (1970–2021) is unknown, and hence, the absolute frequency of serious adverse events cannot be accurately estimated.…”

“…184 There were 7 reports of stroke and 3 reports of TIA recorded in the FAERS database between 1998 and 2021. 13 Most patients have no prior history of TIA or stroke and the most common risk factor is a PFO. Stroke in most cases has been confirmed by ischaemic changes on brain imaging.…”

“…65,165,197,198 In a recent review of the FAERS database of FDA, death from cardiac arrest was the most common cause of death following a serious adverse reaction to POL reported in eight patients. 13 Other cardiac causes of death from POL administration included three cases of atrioventricular block and two cases of ventricular tachycardia. 13 By contrast, no cardiac causes of death were reported following the administration of STS.…”

“…The absolute frequency of these significant adverse reactions is possibly very low given that the total number of sclerotherapy procedures performed in the same period (1970–2021) is unknown but likely to be very high. 13…”

Skin necrosis following sclerotherapy. Part 2: Risk minimisation and management strategies

“…This sludge was previously isolated by our group and shown to be a complex of apolipoprotein B and fibrinogen. 16 In a recent review of serious adverse events of sclerotherapy reported to the Federal Adverse Event Reporting System (FAERS) database of the U.S. Food and Drug Administration (FDA) in a 51 year period (1970–2021), 17 STS recorded 34 cases of skin necrosis. By contrast, POL had 0 reports of injection site necrosis or skin ulcers, despite having an overall higher number of adverse events reported at 863 cases compared to 312 cases for STS.…”