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Current Drug Safety

Volume 6 Issue 1
ISSN: 1574-8863
eISSN:

 

   All Titles

  Are the Long-Acting Intramuscular Formulations of Risperidone or Paliperidone Palmitate Associated with Post-Injection Delirium/Sedation Syndrome? An Assessment of Safety Databases
  pp.43-45 (3) Authors: Larry Alphs, Srihari Gopal, Keith Karcher, Justine Kent, Jennifer Kern Sliwa, Stuart Kushner, Isaac Nuamah, Jaskaran Singh
   
      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.

 
  Keywords: Risperidone, Paliperidone Palmitate, Post-Injection Delirium/Sedation Syndrome, LAI, SSEs, MedDRA, HLGT, SMQ, hyperlipidemia, schizophrenia, parkinsonism, Placebo, microsphere, drug
  Affiliation: Ortho-McNeil Janssen Scientific Affairs, 1125 Trenton-Harbourton Road, A32501, Titusville, NJ 08560, USA.
 
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