Oseltamivir: cutaneous and neurological adverse effects in children
Insights
Oseltamivir, an influenza antiviral, has limited effectiveness and potential serious adverse events in children, including neurological and behavioral issues. Weigh these risks against its modest benefits for influenza treatment and prevention.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Infectious Diseases
Background:
- Oseltamivir is an antiviral medication used for influenza treatment.
- Limited pediatric safety and efficacy data exist for oseltamivir.
- Concerns have been raised regarding oseltamivir's neurological and behavioral side effects in children.
Purpose of the Study:
- To evaluate the safety and efficacy of oseltamivir in pediatric populations.
- To review reported adverse events associated with oseltamivir use in children.
- To assess the risk-benefit profile of oseltamivir for pediatric influenza management.
Main Methods:
- Review of adverse event reports from regulatory agencies (FDA, EMA).
- Analysis of published literature on oseltamivir's pediatric use.
- Examination of preclinical data from animal studies.
Main Results:
- Oseltamivir demonstrates modest efficacy in influenza prevention and treatment.
- Serious adverse events reported include neurological (delirium, behavioral disorders, hallucinations, convulsions, confusion) and severe cutaneous reactions (Lyell syndrome).
- Neurological toxicity observed in young rats, leading to warnings against use in infants under one year.
Conclusions:
- The benefits of oseltamivir in children appear limited, especially concerning its effectiveness on flu complications.
- Serious adverse effects, including neuropsychiatric events and severe skin reactions, warrant careful consideration.
- The risk-benefit balance of oseltamivir in pediatric populations requires cautious evaluation due to safety concerns and modest efficacy.
Abstract:
(1) Oseltamivir is an antiviral drug used for influenza. It has only been tested in children to a limited extent. (2) A few deaths have been reported in children receiving oseltamivir, in some cases due to neurological causes. All of these deaths occurred in Japan. The European Medicines Agency has described 2 deaths, both attributed to suicide, in adolescents aged 14 and 17 who were taking oseltamivir. Both patients had developed behavioural disorders before their death. (3) According to the US Food and Drug Administration, neuropsychiatric disorders were reported in 32 children (mainly in Japan), and include delirium, behavioural disorders, hallucinations, convulsions and confusion. (4) Disturbing neurological toxicity has been observed in young rats exposed to oseltamivir, leading the American and European agencies to warn against the use of oseltamivir in infants less than one year old. (5) Severe cutaneous adverse effects, including cases of Lyell syndrome, were reported in children taking oseltamivir. (6) In practice, oseltamivir is only modestly effective in the prevention of influenza and treatment of suspected influenza. There is no evidence of an effect on complications of the flu in adults or children at higher risk. The possibility of serious adverse effects should be weighed against the limited benefit of oseltamivir.
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