Neuropsychiatric adverse effects of oseltamivir in the FDA Adverse Event Reporting System, 1999-2012

• Published in: BMJ (Online) Vol. 347; no. jul23 3; p. f4656
• Main Authors: Hoffman, Keith B, Demakas, Andrea, Erdman, Colin B, Dimbil, Mo, Doraiswamy, P Murali
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 23.07.2013; BMJ Publishing Group LTD
• Subjects: Adverse Drug Reaction Reporting Systems; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Behavior disorders; Consciousness; Cross-Sectional Studies; Data Mining; Delirium; Dictionaries; Drug Approval; FDA approval; Hallucinations; Humans; Influenza; Marketing; Mental Disorders - chemically induced; Mental Disorders - diagnosis; Mental Disorders - epidemiology; Oseltamivir; Oseltamivir - adverse effects; Oseltamivir - therapeutic use; Product Surveillance, Postmarketing - statistics & numerical data; Substance-Related Disorders - diagnosis; Substance-Related Disorders - epidemiology; Substance-Related Disorders - etiology; United States; United States Food and Drug Administration; United States; United States > US; Japan
• ISSN: 0959-8138; 1756-1833; 1756-1833
• DOI: 10.1136/bmj.f4656

1 2 Cochrane Collaborators, the BMJ, and others, however, contend that many of Roche's data remain unavailable. 3 We examined neuropsychiatric adverse events associated with oseltamivir in the US FDA's Adverse Event Reporting System (FAERS) from October 1999 to August 2012 by using a data mining platform (RxFilterTM; www.AdverseEvents.com 4 ) to generate case report counts and reporting ratios for multiple MedDRA (Medical Dictionary for Regulatory Activities) categories, including those queried in the Roche papers. [...]life threatening" and "death" were listed 188 and 81 times, respectively, in case reports in the largest category searched, "psychiatric disorders (system organ class)". MedDRA terms* Total primary suspect cases† Reporting odds ratio (95% CI) Abnormal behaviour (PT)‡ 980 29.35 (27.43 to 31.40) Psychiatric and behavioural symptoms NEC (HLGT) 1040 15.36 (14.39 to 16.39) Delirium (PT)‡ 317 13.50 (12.05 to 15.12) Hallucination (PT) 477 12.00 (10.93 to 13.17) Perception disturbances (HLT) 597 8.41 (7.74 to 9.14) Delusional disorders, delusional symptoms, perception disturbances (HLTs) 643 8.09 (7.46 to 8.77) Depressed level of consciousness (PT)‡ 211 4.69 (4.09 to 5.38) Deliria (including confusion) (HLGT)‡ 560 3.85 (3.54 to 4.20) Convulsion (PT)‡ 322 2.64 (2.36 to 2.95) Confusional state (PT) 205 2.01 (1.75 to 2.31) Confusion and disorientation (HLT) 262 2.00 (1.77 to 2.26) Psychiatric disorders (SOC) 2527 1.82 (1.74 to 1.90) Cortical dysfunction NEC (HLT) 234 1.82 (1.60 to 2.07) Loss of consciousness (PT)‡ 168 1.58 (1.36 to 1.84) *MedDRA (Medical Dictionary for Regulatory Activities) classes included: PT (preferred term); HLT (high level term); HLGT (high level group term); and SOC (system organ class); NEC=not otherwise classified. †Case counts may reflect multiple neuropsychiatric adverse events in a given subject. ‡Categories included in the referenced Roche papers.