Olanzapine long-acting injection: a review of first experiences of post-injection delirium/sedation syndrome in routine clinical practice

Abstract

BackgroundOlanzapine long-acting injection (LAI) for the treatment of schizophrenia was associated with a cluster of symptoms termed post-injection delirium/sedation syndrome (PDSS) in a small percentage (~2%) of patients during clinical trials. The objective of this analysis was to evaluate the rate and clinical characteristics of PDSS since olanzapine LAI entered commercial use.MethodsCases of PDSS were identified from all reported adverse events during worldwide commercial use of olanzapine LAI through to 1 March 2014. Data sources included two ongoing post-marketing safety studies as well as spontaneously reported adverse events from routine clinical practice over a 5-year period (1 March 2009 to 1 March 2014).ResultsA total of 338 PDSS events were identified. Of these, 91% occurred within 1 hour of injection, and 52% of these occurred within 15 minutes. None of the PDSS events in this analysis were fatal, and most resolved within 72 hours. The most common symptoms (occurring in >30% of cases) were sedation (61%), confusion (56%), dysarthria (54%), somnolence (46%), dizziness (45%) and disorientation (35%). Overall, PDSS occurred with approximately 0.07% of injections and in 0.46–1.03% of patients (reporting and incidence rates from spontaneous reports and post-marketing safety studies, respectively).ConclusionsThe PDSS events reported during routine clinical use of olanzapine LAI are generally similar in incidence and presentation to those reported in clinical trials. Caution should be applied when interpreting spontaneously reported rates of adverse events, however, due to potential under-reporting. Implemented risk-minimisation activities may contribute substantially to the identification and appropriate management of patients with PDSS in clinical practice.Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-015-0450-9) contains supplementary material, which is available to authorized users.

An update of safety of clinically used atypical antipsychotics

“…route of administration. In particular, post-injection delirium/sedation syndrome, characterized by sedation (including coma) and/or delirium has been reported in approximately <0.1% of injections [133][134] Patients with cardiac impairment should be carefully monitored for the increasing risk of orthostatic hypotension. Although olanzapine is not recommended in children and adolescents, preliminary clinical data suggest its relative safety and efficacy for the treatment of behavioral disturbances.…”

Delirium with anticholinergic symptoms after a combination of paliperidone and olanzapine pamoate in a patient known to smoke cannabis: an unfortunate coincidence

“…Cases of patients with PDSS have been reported in the literature. Most of them needed only supportive medical care and all recovered in 1.5–72 hours after injection 4 5…”

Postinjection Delirium Syndrome Associated With Olanzapine Long-Acting Injectable

“…5 The occurrence rate seems to be similar in real-world clinical practice according to ongoing studies. 3 Current data regarding occurrence, development, manifestation, treatment, and outcome of PDSS are still limited. In a review article published in CNS Drugs 2015, the authors claim that only one case of PDSS has been mentioned in connection with OLAI since the last clinical trial ended in August 2008, 11 whereas a recent study based on postmarketing safety studies and spontaneous reports found a total of 338 PDSS events between March 1, 2009, and March 1, 2014.…”

“…1 Olanzapine long-acting injectable, or OLAI, has been associated with the potentially serious adverse event termed postinjection delirium/sedation syndrome (PDSS), caused by high serum concentrations of olanzapine resulting from unintended intravascular injection of OLAI. [2][3][4] Signs and symptoms of PDSS are consistent with olanzapine overdose, including sedation (ranging from mild in severity to coma) and/or delirium (including confusion, disorientation, agitation, anxiety, and other cognitive impairment). Further symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension, and seizure.…”

“…Further symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension, and seizure. 3,5 To some extent, the symptoms of PDSS also can mimic neuroleptic malignant syndrome (NMS), serotonin syndrome (SS), and central anticholinergic syndrome (CAS), 3 rare but potentially lifethreatening conditions. 6,7 Here, we report the case of a female patient developing a severe PDSS after an injection with OLAI and discuss two of the differential diagnoses in relation to the management and treatment of PDSS.…”