Neuropsychiatric adverse effects of oseltamivir in the FDA adverse event reporting system, 1999-2012

BMJ (Online)

Volumn 347, Issue 7918, 2013, Pages

  Hoffman, Keith B ^a   Demakas, Andrea ^a   Erdman, Colin B ^a   Dimbil, Mo ^a   Doraiswamy, P Murali ^b  

^a AdverseEvents   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

OSELTAMIVIR;

BEHAVIOR DISORDER; CASE CONTROL STUDY; COMORBIDITY; DELIRIUM; DRUG APPROVAL; DRUG LABELING; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HALLUCINATION; HUMAN; LETTER; MEDICAL LITERATURE; MENTAL DISEASE; PERCEPTION DISORDER; PRIORITY JOURNAL; PSYCHOPATHY; SYMPTOM;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTIVIRAL AGENTS; CROSS-SECTIONAL STUDIES; DATA MINING; DRUG APPROVAL; HUMANS; MENTAL DISORDERS; OSELTAMIVIR; PRODUCT SURVEILLANCE, POSTMARKETING; SUBSTANCE-RELATED DISORDERS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84880904079     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.f4656     Document Type: Letter

References (6)

1. Toovey S, Prinssen EP, Rayner C.R., Thakrar BT, Dutkowski R, Koerner A, et al Post-marketing assessment of neuropsychiatric adverse events in influenza patients treated with oseltamivir: an updated review. Adv Ther 2012;29:826-48.
2. Greene SK, Li L, Shay D.K., Fry AM, Lee GM, Jacobsen SJ, et al Risk of adverse events following oseltamivir treatment in influenza outpatients, Vaccine Safety Datalink Project, 2007-2010. Pharmacoepidemiol Drug Saf 2013;22:335-44.
3. Open Data Campaign. Tamiflu correspondence with Roche. www.bmj.com/tamiflu/roche.
4. Hoffman KB, Overstreet BM, Doraiswamy PM Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events. Drugs and Therapy Studies (in press)
5. US Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) (formerly AERS). www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default. htm.
6. Szarfman A, Tonning J, Doraiswamy PM Pharmacovigilance in the 21st century: new systematic tools for an old problem. Pharmacotherapy 2004;24:1099-144.