Le Moigne M, Bulteau S, Grall-Bronnec Marie, Gerardin M, Fournier Jean-Pascal, Jonville-Bera A P, Jolliet Pascale, Dreno Brigitte, Victorri-Vigneau C
a Dermato-Oncology Unit , University Hospital Hôtel-Dieu , Nantes , France.
b Addictology and Psychiatry Department , 'Behavioral Addictions/Complex Affective Disorders' Clinical Investigation Unit , Nantes , France.
Expert Opin Drug Saf. 2017 Sep;16(9):989-995. doi: 10.1080/14740338.2017.1344641. Epub 2017 Jul 12.
The link between isotretinoin, treatment of a severe form of acne, and psychiatric disorders remains controversial, as acne itself could explain the occurrence of psychiatric disorders. This study aims at assessing the disproportionality of psychiatric adverse events reported with isotretinoin in the French National PharmacoVigilance Database, compared with other systemic acne treatments and systemic retinoids.
Data were extracted from the French National PharmacoVigilance Database for systemic acne treatments, systemic retinoids and drugs used as comparators. Each report was subjected to double-blind analysis by two psychiatric experts. A disproportionality analysis was performed, calculating the number of psychiatric ADRs divided by the total number of notifications for each drug of interest.
Concerning acne systemic treatments: all 71 reports of severe psychiatric disorders involved isotretinoin, the highest proportion of mild/moderate psychiatric adverse events was reported with isotretinoin (14.1%). Among systemic retinoids, the highest proportion of severe and mild/moderate psychiatric events occurred with isotretinoin and alitretinoin.
Our study raises the hypothesis that psychiatric disorders associated with isotretinoin are related to a class effect of retinoids, as a signal emerges for alitretinoin. Complementary studies are necessary to estimate the risk and further determine at-risk populations.
异维A酸（一种用于治疗重度痤疮的药物）与精神障碍之间的联系仍存在争议，因为痤疮本身可能解释精神障碍的发生。本研究旨在评估在法国国家药物警戒数据库中，与其他全身性痤疮治疗药物和全身性维甲酸类药物相比，异维A酸报告的精神科不良事件的不成比例性。
从法国国家药物警戒数据库中提取全身性痤疮治疗药物、全身性维甲酸类药物及用作对照的药物的数据。每份报告由两名精神科专家进行双盲分析。进行了不成比例性分析，计算每种相关药物精神科药品不良反应（ADR）的数量除以通知总数。
关于全身性痤疮治疗药物：所有71例重度精神障碍报告均涉及异维A酸，异维A酸报告的轻度/中度精神科不良事件比例最高（14.1%）。在全身性维甲酸类药物中，异维A酸和阿维A发生的重度和轻度/中度精神事件比例最高。
我们的研究提出了一种假设，即与异维A酸相关的精神障碍与维甲酸类药物的类效应有关，因为阿维A也出现了相关信号。需要进行补充研究以评估风险并进一步确定高危人群。
