Sage Journals: Discover world-class research

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

Get full access to this article

View all access options for this article.

References

Watson

Mansour

. Cosmetic sclerotherapy. J Vasc Surg Venous Lymphat Disord 2017; 5(3): 437–445. DOI: 10.1016/j.jvsv.2017.02.002.

American Society of Plastic Surgeons . Plastic Surgery Statistics Report 2020. Available at: https://www.plasticsurgery.org/documents/News/Statistics/2020/plastic-surgery-statistics-full-report-2020.pdf (2020, accessed 17 August 2021).

Gibson

Gunderson

. Liquid and foam sclerotherapy for spider and varicose veins. Surg Clin North Am 2018; 98(2): 415–429. DOI: 10.1016/j.suc.2017.11.010.

Yiannakopoulou

. Safety concerns for sclerotherapy of telangiectases, reticular and varicose veins. Pharmacology 2016; 98(1–2): 62–69. DOI: 10.1159/000445436.

U.S. Federal Drug Administration . Federal Drug Administration Adverse Event Reporting System Database. Available at: https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/33a0f68e-845c-48e2-bc81-8141c6aaf772/state/analysis (2021, accessed 15 January 2022).

Gupta

Carviel

MacLeod

, et al. Assessing finasteride-associated sexual dysfunction using the FAERS database. J Eur Acad Dermatol Venereol 2017; 31(6): 1069–1075. DOI: 10.1111/jdv.14223.

Mozzicato

. MedDRA. Pharm Med 2009; 23: 65–75. DOI: 10.1007/BF03256752.

Gillet

for the Guideline Group . Complications and side effects: European guidelines for sclerotherapy in chronic venous disorders. Phlebology 2014; 29(1 suppl): 34–38. DOI: 10.1177/0268355514526532.

Myers

Jolley

. Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins. Eur J Vasc Endovasc Surg 2008; 36(5): 602–605. DOI: 10.1016/j.ejvs.2008.06.026.

10.

Goldman

Weiss

. Phlebology and treatment of leg veins. In: Bolognia

Schaffer

Cerroni

(eds) Dermatology. 4th ed. New York: Elsevier; 2018, pp. 2610–2626.

11.

Meseeha

Attia

. Esophageal Varices. Available at: https://www.ncbi.nlm.nih.gov/books/NBK448078/ (2021, accessed 17 August 2021).

12.

Bush

Derrick

Manjoney

. Major neurological events following foam sclerotherapy. Phlebology 2008; 23(4): 189–192. DOI: 10.1258/phleb.2007.007073.

13.

King

O'Byrne

Vasquez

et al. and VANISH-1 Investigator Group . Treatment of truncal incompetence and varicose veins with a single administration of a new polidocanol endovenous microfoam preparation improves symptoms and appearance. Eur J Vasc Endovasc Surg 2015; 50(6): 784–793. DOI: 10.1016/j.ejvs.2015.06.111.

14.

Todd

3rd Wright

and VANISH-2 Investigator Group . The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence. Phlebology 2014; 29(9): 608–618. DOI: 10.1177/0268355513497709.

15.

Davies

Watkins

Oliver

, et al. Adverse neurological events after sodium tetradecyl sulfate foam sclerotherapy - A prospective, observational study of 8056 treatments. Phlebology 2021; 37(2): 97–104. DOI: 10.1177/02683555211051490.

16.

Sawaya

Champlain

Cohen

, et al. Barriers to reporting: Limitations of the maude database. Dermatol Surg 2021; 47(3): 424–425. DOI: 10.1097/DSS.0000000000002832.

17.

Hazell

Shakir

. Under-reporting of adverse drug reactions: A systematic review. Drug Saf 2006; 29: 385–396. DOI: 10.2165/00002018-200629050-00003.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.09 MB

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