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

Hoffman, Keith B.; Demakas, Andrea; Erdman, Colin B.; Dimbil, Mo; Doraiswamy, P. Murali

doi:10.1136/bmj.f4656

Cited by 33 publications

(21 citation statements)

References 4 publications

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“…4) In 2014, members of the Cochrane Collaboration and others reported that NPAEs were increased in the combined on-and off-treatment periods in oseltamivir prophylaxis studies. 2,26) Against such a background, we provide new information to the on-going controversy regarding NPAEs related to oseltamivir.…”

Section: Discussionmentioning

confidence: 99%

“…4) Several cases of oseltamivir-induced NPAEs have been reported, including mania in a Chinese patient 5) and depressive episodes in Korean patients. 6) However, a number of epidemiological studies, controlled studies, and commentaries indicate that there is no relationship between oseltamivir use and NPAEs.…”

mentioning

confidence: 99%

“…14) Data from the FAERS indicate that certain NPAEs are disproportionately reported after oseltamivir use, especially in Japan. 4) To our knowledge, reports from Asian countries other than Japan were not evaluated in the FAERS database. Furthermore, the effect of age and gender on the relationship between oseltamivir and NPAEs has not yet been evaluated using the FAERS database.…”

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confidence: 99%

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Analysis of Neuropsychiatric Adverse Events in Patients Treated with Oseltamivir in Spontaneous Adverse Event Reports

Ueda

Umetsu

Abe

et al. 2015

Biological & Pharmaceutical Bulletin

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There have been concerns that oseltamivir causes neuropsychiatric adverse events (NPAEs). We analyzed the association of age and gender with NPAEs in patients treated with oseltamivir using a logistic regression model. NPAE data were obtained from the U.S. Food and Drug Administration Adverse Event Reporting System (2004 to 2013). The lower limit of the reporting odds ratio (ROR) 95% confidence interval (CI) of "abnormal behavior" in Japan, Singapore, and Taiwan was ≥1. The effects of the interaction terms for oseltamivir in male patients aged 10-19 years were statistically significant. The adjusted ROR of "abnormal behavior" was 96.4 (95% CI, 77.5-119.9) in male patients aged 10-19 years treated with osletamivir. In female patients, the results of the likelihood ratio test for "abnormal behavior" were not statistically significant. The adjusted NPAE RORs were increased in male and female patients under the age of 20 years. Oseltamivir use could be associated with "abnormal behavior" in males aged 10-19 years. After considering the causality restraints of the current analysis, further epidemiological studies are recommended.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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Analysis of Neuropsychiatric Adverse Events in Patients Treated with Oseltamivir in Spontaneous Adverse Event Reports

Ueda

Umetsu

Abe

et al. 2015

Biological & Pharmaceutical Bulletin

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“…Existing data suggest that these events are more likely secondary to influenza infections than oseltamivir therapy. 53,54 It is currently recommended that patients be monitored closely for behavioral abnormalities.…”

Section: Laninamivirmentioning

confidence: 99%

Antiviral Treatments

Ison

2017

Clinics in Chest Medicine

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Most viral respiratory tract infections are caused by classic respiratory viruses, including influenza, respiratory syncytial virus, human metapneumovirus, parainfluenza, rhinovirus, and adenovirus, whereas other viruses, such as herpes simplex, cytomegalovirus, and measles virus, can opportunistically affect the respiratory tract. The M2 inhibitors, amantadine and rimantadine, were historically effective for the prevention and treatment of influenza A but all circulating strains are currently resistant to these drugs. Neuraminidase inhibitors are the sole approved class of antivirals to treat influenza. Ribavirin, especially when combined with intravenous antibody, reduces morbidity and mortality among immunosuppressed patients.

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“…More serious reactions associated with the central nervous system have included delirium and abnormal behavior leading to injury in patients with influenza who received oseltamivir or peramivir. Primarily reported among children, these neurological events often began abruptly and resolved rapidly [57,58]. The contribution of treatment with neuraminidase inhibitors to these events has yet to be established [59], as some of these adverse events may have been related to the influenza infection rather than its treatment.…”

Section: Parainfluenza Virus None Licensed Human Rhinovirusmentioning

confidence: 99%

Antiviral therapy for respiratory viral infections in immunocompromised patients

Shahani

Ariza-Heredia

Chemaly

2017

Expert Review of Anti-infective Therapy

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Respiratory viruses (influenza, parainfluenza, respiratory syncytial virus, coronavirus, human metapneumovirus, and rhinovirus) represent the most common causes of respiratory viral infections in immunocompromised patients. Also, these infections may be more severe in immunocompromised patients than in the general population. Early diagnosis and treatment of viral infections continue to be of paramount importance in immunocompromised patients; because once viral replication and invasive infections are evident, prognosis can be grave. Areas covered: The purpose of this review is to provide an overview of the main antiviral agents used for the treatment of respiratory viral infections in immunocompromised patients and review of the new agents in the pipeline. Expert commentary: Over the past decade, important diagnostic advances, specifically, the use of rapid molecular testing has helped close the gap between clinical scenarios and pathogen identification and enhanced early diagnosis of viral infections and understanding of the role of prolonged shedding and viral loads. Advancements in novel antiviral therapeutics with high resistance thresholds and effective immunization for preventable infections in immunocompromised patients are needed.

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

Cited by 33 publications

References 4 publications

Analysis of Neuropsychiatric Adverse Events in Patients Treated with Oseltamivir in Spontaneous Adverse Event Reports

Analysis of Neuropsychiatric Adverse Events in Patients Treated with Oseltamivir in Spontaneous Adverse Event Reports

Antiviral Treatments

Antiviral therapy for respiratory viral infections in immunocompromised patients

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