Are the long-acting intramuscular formulations of risperidone or paliperidone palmitate associated with post-injection delirium/sedation syndrome? An assessment of safety databases.
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.
Ortho-McNeil Janssen Scientific Affairs, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. LAlphs@its.jnj.com
Larry
L
Alphs
Srihari
S
Gopal
Keith
K
Karcher
Justine
J
Kent
Jennifer Kern
JK
Sliwa
Stuart
S
Kushner
Isaac
I
Nuamah
Jaskaran
J
Singh
D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic / Q000592:standards; D016292:Procedural Sedation; D016208:Databases, Factual / Q000592:standards*; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D003693:Delirium / Q000139:chemically induced* / Q000453:epidemiology*; D006801:Humans; D007273:Injections, Intramuscular; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects*; D000068882:Paliperidone Palmitate; D010168:Palmitates / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects*; D013577:Syndrome
D003692:Delayed-Action Preparations; D007555:Isoxazoles; D010168:Palmitates; D018967:Risperidone; D000068882:Paliperidone Palmitate