Adverse Events Associated With Botox as Reported in a Food and Drug Administration Database

Background Botulinum toxin treatment is the most frequently performed noninvasive cosmetic procedure performed in the USA. Because of its widespread use, an analysis of the adverse event (AE) profile of Botox injections is needed. Methods The FDA Adverse Event Report System was queried using an onli...

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Bibliographic Details
Published in:Aesthetic plastic surgery 2021-06, Vol.45 (3), p.1201-1209
Main Authors: Ahsanuddin, Salma, Roy, Savannah, Nasser, Wissam, Povolotskiy, Roman, Paskhover, Boris
Format: Article
Language:English
Subjects:
Botulinum toxin
Botulinum Toxins, Type A - adverse effects
Botulism
Dysphagia
Humans
Injections
Medicine
Medicine & Public Health
Neuromuscular Agents - adverse effects
Original Article
Otorhinolaryngology
Paresis
Plastic Surgery
United States - epidemiology
United States Food and Drug Administration
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Summary:Background Botulinum toxin treatment is the most frequently performed noninvasive cosmetic procedure performed in the USA. Because of its widespread use, an analysis of the adverse event (AE) profile of Botox injections is needed. Methods The FDA Adverse Event Report System was queried using an online web-based tool to determine the top 15 adverse events reported for four Botox brand names: Botox/Botox Cosmetic, Dysport, and Xeomin. The proportional reporting ratios (PRR) and relative odds ratios (ROR) were determined. A literature review was performed for eight AEs of clinical significance: eyelid/eyebrow ptosis, asthenia, muscular weakness, facial paresis, dysphagia, botulism, and death. Results Botox/Botox Cosmetic had 38367 AEs. Dysport had 3582 AEs. Xeomin had 1405 AEs. All drugs with reported cases of eyelid and eyebrow ptosis had significant PRR and ROR values. The PRR and ROR values for asthenia were not significant in any of the drugs and only reached significance for Dysport for muscular weakness and dysphagia. Both Botox/Botox Cosmetic and Dysport had elevated PRRs and RORs for facial paresis and botulism. While all drugs had at least one reported case of death related to Botox injection use, none of the PRR or ROR values were significant. Conclusion Known AEs for Botox injection use include eyelid/brow ptosis and muscular weakness. Feared but rare complications of Botox injection use include dysphagia, botulism, and possibly death, owing to systemic spread of the toxin. This is the first study to analyze the AE data reported to the FDA on Botox injection use. EBM Level III
ISSN:0364-216X
1432-5241
1432-5241
DOI:10.1007/s00266-020-02027-z