Link Between Hydroxychloroquine Use and Pemphigus Reports
Author Information
Author(s): Baroukhian Justin, Seiffert-Sinha Kristina, Attwood Kristopher, Sinha Animesh A.
Primary Institution: Department of Dermatology, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, United States
Hypothesis
Can an association between hydroxychloroquine use and the development of pemphigus, previously reported in a single case report, be corroborated using population level data?
Conclusion
The study found a significant association between hydroxychloroquine use and increased reports of pemphigus, especially among females.
Supporting Evidence
- The odds of reporting pemphigus were significantly elevated among individuals exposed to hydroxychloroquine.
- The reporting odds ratio for females was over 100-fold greater than for males.
- The study analyzed data from the FDA Adverse Event Reporting System from Q4 of 2003 to Q2 of 2023.
- Hydroxychloroquine exposure rates were significantly different between females and males.
Takeaway
This study looked at many reports and found that using a drug called hydroxychloroquine might make people more likely to get a skin disease called pemphigus.
Methodology
Observational, retrospective, case-control, pharmacovigilance analysis using the FDA Adverse Event Reporting System.
Potential Biases
Notoriety bias may have influenced reporting rates due to media coverage of hydroxychloroquine during the COVID-19 pandemic.
Limitations
Individual reports in FAERS are not validated by the FDA, and adverse events are believed to be widely underreported.
Participant Demographics
Among the 1,545 reports with hydroxychloroquine exposure, 1,366 (81.12%) were females and 4 (0.24%) were males.
Statistical Information
P-Value
< 0.001
Confidence Interval
95% CI, 260.951-306.148
Statistical Significance
p<0.001
Digital Object Identifier (DOI)
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