New Evidence Challenges Longstanding Label Warning for Tamiflu

Oseltamivir (Tamiflu; Roche) has been key in fighting influenza for more than 20 years, with clear benefits in reducing symptom duration and complications when started promptly. However, since its approval, the drug’s label has had a warning about potential neuropsychiatric adverse effects in pediatric patients, such as hallucinations, confusion, or odd behavior. These warnings came mostly from the first reports following the initial rollout of the treatment, particularly from Japan, and have made caregivers and clinicians hesitant to administer it.

Image Credit: Studio F. | stock.adobe.com

A large-scale study published in JAMA Neurology shows strong proof that challenges these concerns. Using information from over 692,000 children ages 5 to 17 years who were part of Tennessee Medicaid from July 2016 through June 2020, researchers compared neuropsychiatric outcomes in children with confirmed influenza who were either given or not given oseltamivir (Tamiflu; Roche). The findings found that influenza itself may increase the risk of neuropsychiatric events. Children who were given the antiviral had about half the risk of these problems compared with those who were untreated.¹

A summary of the findings published by Drugs.com backs up the idea that oseltamivir is safe for pediatric use and may even provide protection against flu-related neuropsychiatric events.² The findings suggested that earlier treatment initiation and cutting down on virus load may explain the benefits.

This updated evidence has significant implications for clinical decision-making. For many years, some clinicians and caregivers avoided prescribing or administering oseltamivir out of fear of neuropsychiatric effects. Now, strong, real-world data shows these fears are unsupported. Now, prescribing and administering antiviral drugs, mainly those at high risk, may begin to shift toward greater use.

Optimizing Pediatric Antiviral Therapy

Pharmacists play a key role in linking new research to real-world medical use. Even though the American Academy of Pediatrics (AAP) advises treating all pediatric patients in hospitals and those at high risk of flu issues, not many follow this advice. A study of 787 doctors across 5 fields in 7 United States children’s hospitals, done between March and June 2024, showed that oseltamivir was advised less than half the time (49.5%) for children in hospitals with the flu.³ When doctors knew the current guidelines, 62.0% suggested using it compared with just 42.4% who were unaware of the guidelines.³

The survey showed that clinicians did not often give oseltamivir to patients who were ill for a long period of time or had non-respiratory symptoms, even if they fit the AAP's treatment guidelines.³ Infectious disease specialists were most likely to recommend oseltamivir but hospitals were the least likely. Clinicians stated that "most respondents (87.4%) believed a randomized trial of oseltamivir (Tamiflu; Roche) in hospitalized children was moderately to extremely important," with hospital duration seen as the most key outcome to assess.³

This evidence points out many key opportunities for pharmacist help. Pharmacists can provide targeted education to health care groups to fill in what they don't know about current guidelines. Pharmacists can work against wrong ideas in care that cause too little prescribing in unusual cases. By using their skill in medication safety and dosing accuracy, pharmacists can ensure appropriate administration, mainly of liquid types for younger children.

Equitable access is still a key concern. A study from Vanderbilt University Medical Center shows that antiviral care is largely underused in young children, mainly those under 2 years old, even though they have a high risk of severe flu outcomes.⁴ Pharmacists can help by facilitating insurance approvals, offering patient resources, and working with doctors to make sure treatment is timely.

Conclusion

The new evidence about the safety of oseltamivir for children questions past fears. They show how prompt use of this drug can guard against flu-related neuropsychiatric events. Pharmacists, as medication experts and frontline patient educators, have an essential role in disseminating this information, reinforcing clinical guidelines, and ensuring that pediatric patients, particularly those at highest risk, receive timely, appropriate therapy. As flu season nears, using this new information each day can yield better results and cut down on avoidable complications in children.

References

1. Antoon JW, Williams DJ, Bruce J, Sekmen M, Zhu Y, Grijalva CG. Influenza With and Without Oseltamivir Treatment and Neuropsychiatric Events Among Children and Adolescents. JAMA Neurology. Published online August 4, 2025. doi:10.1001/jamaneurol.2025.1995

2. https://www.facebook.com/Drugscom. Tamiflu Safe For Children, Study Concludes MedNews. Drugs.com. Published 2025. https://www.drugs.com/news/tamiflu-safe-children-study-concludes-126143.html

3. Center for Infectious Disease Research and Policy. Umn.edu. Published April 28, 2025. Accessed August 11, 2025. https://www.cidrap.umn.edu/influenza-general/clinicians-often-dont-adhere-pediatric-tamiflu-guidelines-analysis-finds

4. Pasley J. Study finds antiviral treatment is largely underused in children with influenza. VUMC News. Published November 13, 2023. https://news.vumc.org/2023/11/13/study-finds-antiviral-treatment-is-largely-underused-in-children-with-influenza/