title: Safety evaluation of laninamivir octanoate hydrate through analysis of adverse events reported during early post-marketing phase vigilance.
abstract: BACKGROUND
  Abnormal behavior and delirium are common in children with influenza. While abnormal behavior and delirium are considered to be associated with influenza encephalopathy, an increased risk of such neuropsychiatric symptoms in patients receiving neuraminidase inhibitor treatment is suspected. Laninamivir octanoate hydrate, recently approved in Japan, is a long-acting neuraminidase inhibitor. It is important to establish a safety profile for laninamivir early, based on post-marketing experiences.
  
  
  METHODS
  Spontaneous safety reports collected in the early post-marketing phase vigilance were analyzed. Adverse events of interest such as abnormal behavior/delirium, dizziness/vertigo, respiratory disorders, shock/syncope, and any other serious events were intensively reviewed by the Safety Evaluation Committee.
  
  
  RESULTS
  Abnormal behavior/delirium was a frequently reported event. Almost all the reported cases were considered to be due to influenza and not laninamivir. There were 32 cases of abnormal behavior/delirium that could lead to dangerous accidents, and these were observed more frequently in males and teenagers. Syncope probably related to the act of inhalation per se of laninamivir was reported during this survey.
  
  
  CONCLUSIONS
  This safety review revealed that the safety profile of laninamivir for abnormal behavior/delirium and syncope was similar to that of other neuraminidase inhibitors. As stated in the labeling, teenage patients inhaling laninamivir should remain under constant parental supervision for at least 2 days and should be closely monitored for behavioral changes to prevent serious accidents associated with abnormal behavior/delirium. Furthermore, to avoid syncope because of inhalation, patients should be instructed to inhale in a relaxed sitting position.
authors: Department of Pediatrics, Kawasaki Medical School, Okayama, Japan.
authors: Takashi
authors: T
authors: Nakano
authors: Akihisa
authors: A
authors: Okumura
authors: Takuya
authors: T
authors: Tanabe
authors: Shimpei
authors: S
authors: Niwa
authors: Masato
authors: M
authors: Fukushima
authors: Rie
authors: R
authors: Yonemochi
authors: Hisano
authors: H
authors: Eda
authors: Hiroyuki
authors: H
authors: Tsutsumi
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D003693:Delirium / Q000139:chemically induced; D005260:Female; D006146:Guanidines; D006801:Humans; D007251:Influenza, Human / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011714:Pyrans; D012794:Sialic Acids; D013575:Syncope / Q000139:chemically induced; D053243:Zanamivir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000998:Antiviral Agents; D006146:Guanidines; D011714:Pyrans; D012794:Sialic Acids; C546918:laninamivir; D053243:Zanamivir