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Q&A: Neuropsychiatric events reported in children prescribed Tamiflu
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Parental reports have surfaced linking the use of Tamiflu to pediatric neuropsychiatric events, including hallucinations, seizures and behavioral changes.
Although parental reports of these adverse events date back to 2012, the neuropsychiatric events experienced by these children may raise concern in parents, especially with the severity of this year’s influenza season.
Edward Bell, PharmD, BCPS, professor of pharmacy practice at Drake University College of Pharmacy and Blank Children’s Hospital and Clinics, spoke with Infectious Diseases in Children regarding proper use of the drug in pediatric patients and whether this worry is warranted.
Q: What is Tamiflu (oseltamivir phosphate, Roche) used for, and how should it be prescribed for pediatric patients?
A: Tamiflu is an antiviral (anti-influenza) neuraminidase inhibitor. It is FDA-labeled and indicated for treatment of acute, uncomplicated influenza A and B infections in both children and adults who have been asymptomatic for no longer than 48 hours. It is also FDA-labeled for prevention of influenza A and B.
The AAP has recommended additional use for children ill enough with influenza to be hospitalized and children with specific factors that put them at high risk for influenza-related complications. Tamiflu can also be considered for use in otherwise healthy children or children living within high-risk households.
Q: Have neuropsychiatric complications been reported in the past regarding Tamiflu? If there have been reports, what were the symptoms and how severe were they?
A: Earlier data suggested that Tamiflu was associated with neuropsychiatric adverse effects, such as delirium, abnormal behavior or hallucinations. These data were reported mostly from Tamiflu use in Japan, which historically has used more of the drug; however, recently published reviews (Toovey, 2012 and FDA) of these data and cohort studies do not indicate a causal relationship with Tamiflu.
These behaviors can occur in children with influenza, especially early in disease and at symptom onset, when Tamiflu is initiated. This can also occur in children when Tamiflu is not used. Epidemiologic information suggests that the disease pathology of influenza, such as fever, is more likely to be the cause of these effects, not Tamiflu.
Q: Other medications, like Miralax (polyethylene glycol 3350, Bayer), have come under fire for causing neurological changes in the pediatric population. What is the likelihood of a medication causing these symptoms in children?
A: Many medications commonly prescribed in the pediatric population can potentially result in neuropsychiatric adverse effects. Often, these effects are rare, but they can certainly be concerning if they occur in your child or your patient. All drugs have potential adverse effects, and thus, it is always wise to balance the benefits against the risks of using them. For example, Tamiflu given several days or more after symptom onset to an otherwise healthy, low-risk child with influenza that is not severe is unlikely to have much benefit and still has a risk of adverse effects. Additionally, someone — whether it be a family or insurance — must pay for use of the drug.
Q: Are there other options for the treatment of influenza symptoms?
A: Three drugs, which are all neuraminidase inhibitors, can be used to treat influenza. These drugs include Tamiflu, Relenza (zanamivir, GlaxoSmithKline) and Rapivab (peramivir, Biocryst). Relenza is orally inhaled, and Rapivab is administered intravenously. All three medications differ by age indications.
Q: What strategies would you suggest for the prevention of influenza in the pediatric population?
A: Vaccination is the best option for prevention of influenza, in addition to appropriate hand hygiene and avoiding exposure to people who have the disease. Although vaccination is preferred, the neuraminidase inhibitors can be used for prevention in specific children and clinical scenarios.
Q: What would you recommend to pediatricians who are treating a child who may benefit from Tamiflu, but the parents are concerned about recent reports?
A: Tamiflu is best used for children who are significantly ill with influenza. When given as soon as possible after symptoms begin, it can provide significant benefit for these children because it inhibits viral replication, which occurs early in the disease process. It is less useful and has quite possibly no benefit for children who are not severely ill and those who are given the drug long after symptoms begin.
For these children, it may not provide any tangible benefit, but it does increase cost and poses a risk for potential adverse effects, but neuropsychiatric effects are not a significant concern. As with antibiotics, increased use of antiviral influenza drugs when not necessary does increase the likelihood of viral resistance. If overused, these drugs may not be as useful in the future.
Q: What do you suggest for pediatricians who are also concerned about recent reports and are hesitant to prescribe Tamiflu to children who may benefit from the drug?
A: There are no real concerns for neuropsychiatric effects when prescribing Tamiflu. Concerns should be focused on its cost to society, adverse effects and the potential development of viral resistance to these drugs. As with all drugs, judicious and wise use, when appropriate, is best. The benefits of using any drug should outweigh the risks. – by Katherine Bortz
Disclosure: Bell reports no relevant financial disclosures.