Are the Long-Acting Intramuscular Formulations of Risperidone or Paliperidone Palmitate Associated with Post-Injection Delirium/Sedation Syndrome? An Assessment of Safety Databases

Larry Alphs,Stuart Kushner,Justine Kent,Srihari Gopal,Isaac Nuamah,Jaskaran Singh,Keith Karcher,Jennifer Kern Sliwa

doi:10.2174/157488611794480070

Abstract

Long-acting injectable (LAI) formulations of antipsychotics are valuable treatment alternatives for patients with psychotic disorders, and understanding their safe use is critical. Post-injection delirium/sedation syndrome (PDSS) has been reported following treatment with one atypical antipsychotic LAI. Clinical databases of risperidone LAI and paliperidone palmitate were explored to identify if cases of PDSS had been observed.No cases of PDSS were identified in 15 completed trials of 3,164 subjects (approximately 115,000 injections) or the postmarketing safety database of risperidone LAI. Only one case of PDSS was identified among 10 completed trials (3,817 subjects, 33,906 injections) of paliperidone palmitate—that case having been reported in a patient randomized to treatment with placebo. Examination of these prospective databases finds no evidence that risperidone LAI and paliperidone palmitate are associated with PDSS and suggest that findings seen with another antipsychotic LAI are not generalizable.

Highlights

Long-acting injectable (LAI) formulations of antipsychotic agents offer advantages to the use of orally administered agents in patients with schizophrenia who have difficulties with compliance and are at risk for relapse [1]
These analyses were performed to determine whether cases of post-injection delirium/sedation syndrome (PDSS) or symptoms consistent with antipsychotic overdose have been reported for risperidone LAI and paliperidone palmitate
No reports or signals of PDSS were identified in subjects treated with either risperidone LAI or paliperidone palmitate

Summary

Introduction

Long-acting injectable (LAI) formulations of antipsychotic agents offer advantages to the use of orally administered agents in patients with schizophrenia who have difficulties with compliance and are at risk for relapse [1]. While these formulations are generally well-tolerated, a review by Citrome [2] and other reports [3,4,5,6,7] indicated a potential for patients to experience a constellation of neurologic symptoms following administration of one atypical antipsychotic LAI that are consistent with overdose and are referred to as post-injection delirium/sedation syndrome (PDSS). These analyses were performed to determine whether cases of PDSS or symptoms consistent with antipsychotic overdose have been reported for risperidone LAI and paliperidone palmitate. EVALUATION OF PDSS WITH RISPERIDONE LAI AND PALIPERIDONE PALMITATE

Results

Conclusion