[Alitretinoin (Toctino ®): A French follow-up study of harmacovigilance].

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.
PMID: 31014976 [PubMed - as supplied by publisher]

Source: Therapie - March 30, 2019 Category: Psychiatry & Psychology Authors: Vrignaud L, Simon C, Agier MS, Théophile H, Gras-Champel V, Beau-Salinas F, Lengellé C, Jonville-Béra AP Tags: Therapie Source Type: research