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Melasma secondary to drugs: a real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS)
Yaxin Qu1, Shuxin Wang1, Hanzhang Xie2
1Department of Dermatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5, Beixiange, Xicheng District, Beijing, 100053, China.
Background:
Melasma is a common hyperpigmentation disorder that causes significant distress to patients. In the real world, it is closely associated with various medications, making the timely identification and discontinuation of causative drugs an important aspect of clinical management. This study investigates the relationship between melasma and drug exposure based on data from the FDA Adverse Event Reporting System (FAERS) database.
Methods:
This study includes reports from the first quarter of 2004 to the second quarter of 2024, focusing on cases related to melasma. We employed four statistical methods to analyze the association between suspected drugs and adverse events related to melasma.
Results:
Within a specific timeframe, we extracted a total of 408 adverse reaction reports related to melasma. The result shows that a higher number of cases in female patients compared to male patients. The United States had the highest number of reported cases. We identified 22 drugs that were notably associated with melasma. Among these, the contraceptive "Ethinylestradiol and norethindrone" demonstrated the strongest signal of association.
Conclusions:
Melasma is associated with exposure to various medications, with a notable proportion of cases coincided with contraceptive use. The mechanisms involved include hormonal disturbances and oxidative stress.
Insights
Melasma, a skin hyperpigmentation, is linked to certain medications, particularly contraceptives. Identifying and stopping these drugs is key for managing melasma and reducing patient distress.
Area of Science:
- Dermatology
- Pharmacovigilance
- Clinical Medicine
Background:
- Melasma is a prevalent hyperpigmentation disorder causing patient distress.
- Association with medications necessitates identification and discontinuation of causative drugs.
- This study explores melasma-drug exposure links using FDA Adverse Event Reporting System (FAERS) data.
Purpose of the Study:
- To investigate the association between melasma and drug exposure.
- To identify specific drugs linked to melasma development.
- To inform clinical management by highlighting potential causative agents.
Main Methods:
- Analysis of FAERS database reports from Q1 2004 to Q2 2024.
- Focus on adverse event reports related to melasma.
- Utilized four statistical methods to assess drug-event associations.
Main Results:
- Extracted 408 melasma-related adverse reaction reports.
- Melasma cases predominantly reported in female patients, with the highest incidence in the United States.
- Identified 22 drugs associated with melasma, notably 'Ethinylestradiol and norethindrone' contraceptive.
Conclusions:
- Melasma is associated with various medications, including contraceptives.
- Hormonal disturbances and oxidative stress are implicated mechanisms.
- Drug-induced melasma requires careful clinical consideration and management.
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