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.

Keywords

Adverse events complications FAERS sclerotherapy sclerosant

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