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Quantitative Fundus Autofluorescence for the Evaluation of Retinal Diseases
Published on: March 11, 2016
Unveiling the hidden ocular risks of isotretinoin: a comprehensive FAERS-Based analysis
Tao Tao1,2,3, Guo Lei Du4, Zhi-Jie Zhang5
1Chongqing Key Laboratory of Development and Utilization of Genuine Medicinal Materials in Three Gorges Reservoir Area, Chongqing Three Gorges Medical College, China.
Objective:
While extensive research has been conducted on isotretinoin's systemic side effects, studies focusing on its ocular side effects remain limited and often lack substantial sample sizes. To address this gap, we conducted a comprehensive investigation of isotretinoin-related ocular toxicity using data from the FAERS spanning 2004 to 2024.
Methods:
After excluding duplicate and incomplete records from the FAERS database, we identified 760 eye-related adverse event reports from a total of 45,258 isotretinoin-related entries. We employed the Reporting Odds Ratio (ROR) method to assess the risk of ocular problems. Additionally, we examined the onset timing of eye toxicity.
Results:
Among the 760 reports analyzed, dry eye emerged as the most frequently reported condition (n = 222), although it did not exhibit the strongest association. The ROR was observed for night blindness (ROR = 35.8, 95% CI = 29.66-43.21), indicating a significant risk. This finding underscores the need to focus on isotretinoin's impact on the retina and fundus, especially since night blindness and vision loss can manifest as early as the first day of treatment.
Conclusion:
These findings prompt new recommendations for safety monitoring by clinicians. However, additional clinical and fundamental research is essential to substantiate these observations and further elucidate the effects of isotretinoin on ocular health.
Insights
Isotretinoin use is linked to significant ocular risks, particularly night blindness, which can occur early in treatment. This study highlights the need for increased clinical monitoring of isotretinoin
Area of Science:
- Ophthalmology
- Pharmacovigilance
- Dermatology
Background:
- Extensive research exists on isotretinoin's systemic side effects.
- Studies on isotretinoin's ocular side effects are limited and often lack large sample sizes.
Purpose of the Study:
- To investigate isotretinoin-related ocular toxicity.
- To assess the risk and onset timing of eye-related adverse events associated with isotretinoin.
Main Methods:
- Utilized data from the FDA Adverse Event Reporting System (FAERS) from 2004 to 2024.
- Analyzed 760 eye-related adverse event reports from 45,258 isotretinoin entries.
- Employed the Reporting Odds Ratio (ROR) method to assess ocular risks.
Main Results:
- Dry eye was the most frequently reported condition (n=222), but not the most strongly associated.
- Night blindness showed a significant association (ROR=35.8), indicating a high risk.
- Ocular toxicity, including night blindness and vision loss, can manifest early in treatment.
Conclusions:
- Findings suggest a significant risk of ocular toxicity with isotretinoin, particularly affecting vision.
- New safety monitoring recommendations for clinicians are prompted by these results.
- Further clinical and fundamental research is needed to fully understand isotretinoin's ocular effects.
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