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arznei-telegramm 2013; 44: 22-3

 


Injection site abscess due to depot neuroleptic paliperidone (XEPLION): A 24-year-old female patient with schizophrenia receives a monthly intramuscular injection of the depot neuroleptic paliperidone palmitate (XEPLION). Within 16 months an abscess-type reaction at the injection site developed a total of three times. After abscess incision, there was delayed healing with an absence of microbial detection (NETZWERK Report 16.287). Irritation at the injection site has already been observed in animal studies at all of the dosage levels tested. Abscesses at the injection site occurred in long-term studies with rats and dogs (EMA: European Public Assessment Report [EPAR] XEPLION, as at March 2011). Since then the European Medicines Agency (EMA) has documented a number of reports of serious injection site reactions, including five reports of abscess formation (European database of suspected adverse drug reaction reports on XEPLION, as at Dec. 2012; can be found at http://www.adrreports.eu). Paliperidone is the active metabolite of risperidone; serious injection site reactions such as abscess, necrosis, cyst, etc., have also become known during use of the depot risperidone formulation RISPERDAL CONSTA since market launch. A few patients required a surgical procedure (Janssen-Cilag: SPC of RISPERDAL CONSTA, as at Jan. 2012). The product information currently available on the website of the European Medicines Agency EMA now indicates subcutaneous abscess as uncommon (0.1% to below 1%) and abscess, cyst and cellulitis at the injection site as rare (0.01% to below 0.1%) adverse effects with XEPLION (EMA: Product Information XEPLION, Feb. 2013). The supplier Janssen-Cilag will not be updating the German SPC until 1st March 2013 (letter dated 13 Feb. 2013). We advise against paliperidone depot. According to EPAR, two out of three comparative studies failed to demonstrate non-inferiority of the drug compared with risperidone depot, whose own therapeutic value is disputed (a-t 2004; 35: 44 and 2011; 42: 38). -Ed.



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