| Popis: |
Background Several studies have investigated gender as a risk factor for the occurrence of adverse drug events (ADEs) and found that females are more likely to experience ADEs than male. Today, there is a poor knowledge about gender differences in safety profile of ADEs to hydroxychloroquine (HCQ). Identifying those gender differences in ADEs could reduce the experience of ADEs for patients with HCQ. Therefore, the aim of this explorative study was to investigate whether differences exist in reported ADEs of HCQ for male and female in the database of FDA Adverse Event Reporting System (FAERS). Methods We performed a descriptive gender-related analysis and disproportionality analysis of HCQ safety data, obtained from the FAERS. Reporting odds ratio (ROR) and 95% confidence interval (CI) were calculated to quantify the signals of gender differences for specific drug-event combinations at system organ class (SOC) and preferred term (PT) level. Results Disproportionality analysis indicated that 8 SOCs with 12 ADEs were statistically significantly more reported in female than male, including electrocardiogram Qt prolonged, retinal toxicity, musculoskeletal disorder, hypersensitivity, anaphylactic reaction, among others, and 5 SOCs with 11 ADEs were reported more in male than female, including cardiac failure, renal failure, completed suicidal, photosensitivity reaction. Common adverse events are similar between female and male. However, serious ADEs were more frequently reported in males. Conclusions Therefore, the recognition of gender differences in ADEs may be helpful in prescribing medications, e.g. greater caution should be taken when prescribing HCQ to female with conduction disorder. |
