Is Tamiflu (Oseltamivir) safe for pediatrics?

From the Guidelines

Tamiflu (oseltamivir) is generally safe for pediatric use when prescribed appropriately, as it is FDA-approved for treating and preventing influenza in children as young as 2 weeks old. For treatment, the typical dosage for children is based on weight:

• 2 weeks to <1 year: 3 mg/kg twice daily for 5 days
• ≥1 year: 30-75 mg twice daily for 5 days, depending on weight For prevention, it's usually given once daily for 10 days after exposure. Common side effects may include nausea, vomiting, and headache, as noted in the study by 1. Rare neuropsychiatric events have been reported, so monitor for unusual behavior. Tamiflu works by inhibiting the influenza virus's ability to spread within the body, reducing symptom severity and duration. It's most effective when started within 48 hours of symptom onset. While generally safe, it should be prescribed by a healthcare provider who can assess the child's individual needs and risks, as recommended by 1. The American Academy of Pediatrics (AAP) considers oseltamivir to be the preferred postexposure chemoprophylaxis for patients with influenza A and/or B, as stated in the study by 1. The AAP also recommends that oseltamivir be used to treat influenza in both term and preterm infants from birth because benefits of therapy are likely to outweigh possible risks of treatment, as noted in the study by 1. However, the development of resistance to oseltamivir in children may be more common than appreciated, as reported in the study by 1. Therefore, it is essential to use oseltamivir judiciously and only when clinically indicated, as recommended by 1. In addition, the dosage and administration of oseltamivir should be carefully followed, as outlined in the study by 1, to minimize the risk of adverse effects and ensure optimal efficacy. Overall, the benefits of oseltamivir in treating and preventing influenza in children outweigh the risks, as long as it is used appropriately and under the guidance of a healthcare provider, as recommended by 1.

From the FDA Drug Label

The safety and efficacy of oseltamivir phosphate for the treatment of influenza in pediatric patients 2 weeks old to 17 years of age has been established [see Dosage and Administration (2.2), Clinical Pharmacology (12.3), and Clinical Studies (14. 1)] and is based on: 13 to 17 years of age: Safety and efficacy in adolescent patients 13 to 17 years of age was supported by adequate and well-controlled trials in adults and adolescents and younger pediatric patients and safety data in adolescents treated with oseltamivir phosphate in a study of treatment and prophylaxis 1 year to 12 years of age: Safety and efficacy in pediatric patients 1 year to 12 years of age was supported by results of one double-blind, placebo-controlled trial in 452 pediatric patients with influenza in whom oseltamivir phosphate 2 mg per kg twice daily or placebo was administered within 48 hours of symptom onset [see Clinical Studies (14. 1)]. 2 weeks to less than 1 year of age: Safety and efficacy in pediatric patients 2 weeks to less than 1 year of age is supported by adequate and well-controlled trials in adults and older pediatric patients and two open-label trials of oseltamivir phosphate (2 to 3. 5 mg per kg twice daily for 5 days) in 136 pediatric subjects 2 weeks to less than 1 year of age.

The safety and efficacy of oseltamivir phosphate for the treatment of influenza in pediatric patients 2 weeks old to 17 years of age has been established.

• For patients 13 to 17 years of age, safety and efficacy were supported by adequate and well-controlled trials.
• For patients 1 year to 12 years of age, safety and efficacy were supported by one double-blind, placebo-controlled trial.
• For patients 2 weeks to less than 1 year of age, safety and efficacy were supported by adequate and well-controlled trials in adults and older pediatric patients and two open-label trials. However, the safety and efficacy of oseltamivir phosphate for treatment of influenza in pediatric patients less than 2 weeks of age have not been established 2.

From the Research

Safety of Tamiflu (Oseltamivir) in Pediatrics

• The U.S. Food and Drug Administration (FDA) has approved the use of oseltamivir phosphate (Tamiflu) for treatment of uncomplicated influenza in patients two weeks and older 3.
• Oseltamivir treatment should be recommended only in severe influenza cases, especially if confirmed by reliable laboratory tests, and therapy must be initiated considering the risk of complications and the presence of severe clinical manifestations at age- and weight-appropriate doses 4.
• A study of 1300 children found that oseltamivir was well tolerated and reduced the intensity of influenza symptoms, thus reducing the number of days of hospitalization and post-infection complications in both groups 5.
• Another study found that oseltamivir was effective in the treatment of children with influenza, with a liquid formulation of oseltamivir (2 mg/kg twice daily for 5 days) showing efficacy in the treatment of children with influenza 6.
• A study of 35 infants under one year of age found that oseltamivir was well tolerated, with no neurological, dermatological, or gastrointestinal side effects reported, and mild elevations in liver enzymes were present in 39.1% of patients with available blood workup at presentation, but no changes in liver enzymes were observed with oseltamivir treatment 7.

Adverse Reactions and Monitoring Parameters

• The most commonly reported adverse events with oseltamivir are nausea and vomiting, which are mild and transient, and can be reduced by taking the medication with food 6.
• Monitoring parameters for oseltamivir in pediatric patients include dosing, adverse reactions, and liver enzyme levels 3, 7.
• Comorbidities such as asthma, gastrointestinal diseases, and metabolic and endocrine diseases may be associated with prolonged duration of hospitalization in pediatric patients treated with oseltamivir 5.

Efficacy and Effectiveness

• Oseltamivir has been shown to be effective in reducing the duration of symptomatic illness and hastening the return to normal levels of activity in patients with naturally acquired influenza 6.
• The medication has also been shown to reduce the incidence of secondary complications and the use of antibacterials in pediatric patients with influenza 5, 6.
• Oseltamivir may be used as a therapeutic alternative to other antiviral medications, especially in patients who prefer oral administration or have an underlying respiratory disorder 6.