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

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

Volume: 6 Issue: 1

Author(s): Larry Alphs, Srihari Gopal, Keith Karcher, Justine Kent, Jennifer Kern Sliwa, Stuart Kushner, Isaac Nuamah and Jaskaran Singh

Affiliation:

Keywords: Risperidone, Paliperidone Palmitate, Post-Injection Delirium/Sedation Syndrome, LAI, SSEs, MedDRA, HLGT, SMQ, hyperlipidemia, schizophrenia, parkinsonism, Placebo, microsphere, drug

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.

Cite this article as:

Alphs Larry, Gopal Srihari, Karcher Keith, Kent Justine, Kern Sliwa Jennifer, Kushner Stuart, Nuamah Isaac and Singh Jaskaran, Are the Long-Acting Intramuscular Formulations of Risperidone or Paliperidone Palmitate Associated with Post-Injection Delirium/Sedation Syndrome? An Assessment of Safety Databases, Current Drug Safety 2011; 6 (1) . https://dx.doi.org/10.2174/157488611794480070