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Psychiatric disorders, acne and systemic retinoids: comparison of risks
M Le Moigne1, S Bulteau2, Marie Grall-Bronnec2,3
1a Dermato-Oncology Unit , University Hospital Hôtel-Dieu , Nantes , France.
Expert Opinion on Drug Safety
|June 29, 2017
Summary
Isotretinoin, used for severe acne, may be linked to psychiatric disorders as a class effect of retinoids, not just acne itself. Further research is needed to confirm risks and identify vulnerable populations.
Area of Science:
- Dermatology
- Psychiatry
- Pharmacovigilance
Background:
- The association between isotretinoin for severe acne and psychiatric disorders is debated, as acne itself may cause psychiatric issues.
- This study investigates psychiatric adverse events linked to isotretinoin compared to other acne treatments.
Purpose of the Study:
- To assess the disproportionality of psychiatric adverse events reported with isotretinoin.
- To compare isotretinoin's psychiatric adverse event profile with other systemic acne treatments and retinoids.
Main Methods:
- Data from the French National PharmacoVigilance Database were analyzed.
- Psychiatric adverse drug reactions (ADRs) were assessed using double-blind analysis by experts.
- Disproportionality analysis was conducted to quantify the risk of psychiatric ADRs for each drug.
Main Results:
- All 71 reports of severe psychiatric disorders were associated with isotretinoin among systemic acne treatments.
- Isotretinoin showed the highest proportion of mild/moderate psychiatric adverse events (14.1%).
- Isotretinoin and alitretinoin had the highest proportion of severe and mild/moderate psychiatric events among systemic retinoids.
Conclusions:
- Psychiatric disorders linked to isotretinoin may be a class effect of retinoids, with a signal also noted for alitretinoin.
- Further studies are required to quantify the risk and identify at-risk populations.
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