AI Article Synopsis
- Alitretinoin, a retinoid for severe hand eczema, has a similar side effect profile to isotretinoin but shows a higher incidence of serious psychiatric disorders.
- In a study analyzing adverse drug reactions (ADRs) from 2012 to 2016, 52 serious and 88 non-serious unexpected ADRs were reported, including new cases like myocardial infarction and pancreatitis.
- Due to these findings, particularly the significant rate of psychiatric issues and pregnancy exposures, the French National Agency for Medicines has restricted initial prescriptions of alitretinoin.
Article Abstract
Introduction: The adverse reaction profile of alitretinoin, a retinoid indicated in severe topical corticosteroid-refractory chronic hand eczema, is similar to that of other oral retinoids, especially isotretinoin. The objective of this study was to detect new adverse effects (not listed) of alitretinoin and to estimate the number of pregnancies exposed.
Material And Methods: All cases of ADR reported in France with alitretinoin between October 1st, 2012 and February 29th, 2016 were analysed.
Results: During the 41 months of follow-up, 52 cases of serious adverse drug reaction (ADR) and 88 cases of non-serious and unexpected ADR were notified. The most frequent serious ADRs were psychiatric, neurological and dermatological. Psychiatric disorders, mainly depression and suicidal ideation represented 23% of serious ADRs. New adverse drug reactions were detected: myocardial infarction, pancreatitis and digestive haemorrhage. Three pregnancies exposed during the teratogenic risk period, were registered.
Discussion And Conclusion: The safety profile of alitretinoin matches that of other retinoids. However, the rate of psychiatric disorders appears to be high. Otherwise, the risk of myocardial infarction in patients with cardiovascular risk factor should be considered as a safety concern. It could be explained by the hyperlipemic effects of alitretinoin and studies suggest a cardiovascular risk with retinoids through their effects on lipids (class effect), especially for patients with others cardiovascular risk factors. Pancreatitis and digestive hemorrhage are described with isotretinoin. The rate of reporting of pregnancy induced by a non-compliance with the Pregnancy Prevention Program is near the rate observed with isotretinoin. The high incidence of serious ADR and the non-application of pregnancy prevention program lead the French National Agency for Medicines to limit the first prescription of alitretinoin to dermatologists.
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| http://dx.doi.org/10.1016/j.therap.2019.02.006 | DOI Listing |
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