Oral isotretinoin associated with psychiatric symptoms
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Oral isotretinoin associated with psychiatric symptoms Oral isotretinoin [Roaccutan] for the treatment of severe acne is associated with pysychiatric symptoms, according to a Danish Health and Medicines Authority (DHMA) study, although reporting is in line with current information on psychiatric ADRs in the summary of product characteristics (SmPC). There were 276 reports related to isotretinoin in the DHMA’s adverse reaction database between 1985 and 2012. Of these reports, 120 covered a total of 174 psychiatric adverse reactions. Depression was the most frequently reported adverse reaction (80 cases) followed by anxiety (10) and aggression (8). Overall, the types of psychiatric adverse reactions reported in the Danish database were in line with those described in the SmPC. Most psychiatric reports (62%) were from individuals aged 15–25 years, matching the peak age group for users of the drug. The report concludes that "information on psychiatric adverse reactions in the summary of product characteristics is still deemed adequate", adding that doctors should carefully assess treatment in patients with a history of depression. Danish Health and Medicines Authority. Isotretinoin (Roaccutan etc.) for the treatment of severe acne, and adverse reaction reports related to psychiatric symptoms. Danish Pharmacovigilance Update 3: 2-4, No. 5, 24 May 2012. 803075095 Available from: URL: http://laegemiddelstyrelsen.dk
0114-9954/10/1414-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 11 Aug 2012 No. 1414
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