The safety of oseltamivir in patients with influenza: analysis of healthcare claims data from six influenza seasons.
BACKGROUND
Recently, neuropsychiatric events associated with oseltamivir treatment have been reported, mainly in pediatric patients in Japan.


OBJECTIVE
To explore the influence of oseltamivir treatment on central nervous system (CNS)-related and neuropsychiatric events in adults, children, and adolescents with influenza.


METHODS
A retrospective cohort study using propensity-matched data for 6 influenza seasons (2000-2006).


METHODS
Claims data were obtained from the Thomson Healthcare MarketScan Research Database.


METHODS
Patients of all ages and in subgroups aged 12 years or younger, 13-17 years, and 18-49 years diagnosed with influenza.


METHODS
Claims for CNS and neuropsychiatric events within 14 and 30 days following influenza diagnosis were compared between patients prescribed oseltamivir and those not prescribed antiviral treatment.


RESULTS
Data for 40,704 patients prescribed oseltamivir (9599 aged 12 years or younger; 4615, 13-17 years; and 16,910, 18-49 years) and 40,704 matched controls (9599 aged 12 years or younger; 4621, 13-17 years; and 16,898, 18-49 years) were analyzed. None of the CNS-related and neuropsychiatric events was more likely to occur in patients prescribed oseltamivir. Overall, CNS-related or neuropsychiatric events (odds ratio [OR] 0.76; 95% confidence intervals [CI]: 0.68, 0.84), psychiatric events (OR 0.82; 95% CI: 0.70, 0.96), and disturbances of consciousness (OR 0.61; 95% CI: 0.48, 0.76) within 14 days after influenza diagnosis were all less likely in patients given oseltamivir. Findings were similar within the 30-day post-index time window and across all age groups.


CONCLUSIONS
No increase in CNS-related and neuropsychiatric events was observed in adults, children, or adolescents with influenza who were prescribed oseltamivir in this study.
Blumentals
William A
WA
Medical Data Analytics, Roche Laboratories, Nutley, New Jersey, USA. william.blumentals@roche.com
Song
Xue
X
D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001921:Brain / Q000187:drug effects; D016022:Case-Control Studies; D002493:Central Nervous System Diseases / Q000139:chemically induced / Q000453:epidemiology*; D002648:Child; D015331:Cohort Studies; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007251:Influenza, Human / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D007348:Insurance, Health; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced / Q000453:epidemiology*; D008875:Middle Aged; D016017:Odds Ratio; D053139:Oseltamivir / Q000008:administration & dosage / Q000009:adverse effects*; D011336:Probability; D012042:Registries; D012189:Retrospective Studies; D012720:Severity of Illness Index; D017678:Sex Distribution
D000998:Antiviral Agents; D053139:Oseltamivir