{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,13]],"date-time":"2025-10-13T19:10:38Z","timestamp":1760382638152},"reference-count":44,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2012,11,5]],"date-time":"2012-11-05T00:00:00Z","timestamp":1352073600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2013,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>An association between the influenza antiviral medication oseltamivir and neuropsychiatric events has been suggested by post\u2010marketing case reports in Japan. This possible association was not supported by cohort studies in the U.S. conducted prior to the 2009 influenza A (H1N1) pandemic, when usage rates were comparatively low. We assessed oseltamivir safety before and during the pandemic using biologically plausible risk intervals, particularly focusing on psychiatric events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Outpatients with influenza episodes from January 2007 through June 2010 were identified using diagnosis codes and positive tests at eight health care systems (sites) in the Vaccine Safety Datalink Project. Oseltamivir\u2010treated and untreated patients were matched according to calendar week, age, sex, site, and propensity for treatment. Within this matched cohort, conditional logistic regression models were used to estimate the risk of four neuropsychiatric and five other adverse events (AEs) during pre\u2010specified risk intervals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 27\u2009684 matched pairs, no associations were identified between oseltamivir treatment and any pre\u2010defined AE. The absolute risks of incident psychiatric events in the 1\u20137 day risk interval were 0.126% for oseltamivir\u2010treated and 0.105% for untreated patients (odds ratio\u2009=\u20091.21, 95% confidence interval [CI]: 0.74, 1.97; risk difference\u2009=\u20090.022%, 95% CI: \u22120.035%, 0.078%); the most common diagnosis was unspecified anxiety state. Results were similar for 1\u201314 and 1\u20132 day risk intervals and for pediatric\/adolescent subgroups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Consistent with prior U.S. cohort studies, no evidence was identified for an increased risk of neuropsychiatric or other AEs following oseltamivir treatment. Safety should be prospectively monitored to inform antiviral medication usage recommendations. Copyright \u00a9 2012 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3363","type":"journal-article","created":{"date-parts":[[2012,11,5]],"date-time":"2012-11-05T14:01:10Z","timestamp":1352124070000},"page":"335-344","source":"Crossref","is-referenced-by-count":17,"title":["Risk of adverse events following oseltamivir treatment in influenza outpatients, Vaccine Safety Datalink Project, 2007\u20132010"],"prefix":"10.1002","volume":"22","author":[{"given":"Sharon K.","family":"Greene","sequence":"first","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lingling","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David K.","family":"Shay","sequence":"additional","affiliation":[{"name":"Influenza Division Centers for Disease Control and Prevention  Atlanta Georgia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alicia M.","family":"Fry","sequence":"additional","affiliation":[{"name":"Influenza Division Centers for Disease Control and Prevention  Atlanta Georgia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Grace M.","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"},{"name":"Division of Infectious Diseases and Department of Laboratory Medicine Children's Hospital Boston  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven J.","family":"Jacobsen","sequence":"additional","affiliation":[{"name":"Department of Research and Evaluation Kaiser Permanente Southern California  Pasadena California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roger","family":"Baxter","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Vaccine Study Center  Oakland California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie A.","family":"Irving","sequence":"additional","affiliation":[{"name":"Epidemiology Research Center Marshfield Clinic Research Foundation  Marshfield Wisconsin USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael L.","family":"Jackson","sequence":"additional","affiliation":[{"name":"Group Health Research Institute  Seattle Washington USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allison L.","family":"Naleway","sequence":"additional","affiliation":[{"name":"Kaiser Permanente Northwest Center for Health Research  Portland Oregon USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James D.","family":"Nordin","sequence":"additional","affiliation":[{"name":"HealthPartners Research Foundation  Minneapolis Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Komal J.","family":"Narwaney","sequence":"additional","affiliation":[{"name":"Institute for Health Research Kaiser Permanente Colorado  Denver Colorado USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tracy A.","family":"Lieu","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"},{"name":"Division of General Pediatrics Children's Hospital Boston  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,11,5]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"Genentech USA Inc.Tamiflu (oseltamivir phosphate) capsules and for oral suspension [Package insert]. 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