What are the actual benefits of Tamiflu (Oseltamivir)?

From the Guidelines

Tamiflu (oseltamivir) is recommended for the treatment of influenza in children and adults, as it has been shown to reduce the duration of flu symptoms by approximately 1-2 days when started within 48 hours of symptom onset, as evidenced by a meta-analysis of 5 new RCTs that included 1598 children with laboratory-confirmed influenza 1. The benefits of Tamiflu include:

• Reducing the duration of flu symptoms by approximately 1-2 days when started within 48 hours of symptom onset
• Decreasing the severity of flu symptoms, potentially reducing complications like pneumonia, bronchitis, and sinus infections, particularly in high-risk individuals such as the elderly, young children, pregnant women, and those with chronic health conditions
• Preventing influenza after exposure, with a prescribed dosage of 75mg once daily for 7-10 days The standard adult dosage of Tamiflu is 75mg twice daily for 5 days, while the dosage for children varies based on their weight and age, as outlined in the recommended dosage and schedule of influenza antiviral medications for treatment and chemoprophylaxis in children for the 2019-2020 influenza season 1. It's essential to note that Tamiflu is not a substitute for annual flu vaccination, works best when started early, and may cause side effects including nausea, vomiting, and headache, with vomiting being the only adverse effect reported more often with oseltamivir compared to placebo in children 1 through 12 years of age 1. In terms of treatment decisions, clinical judgment is crucial, taking into account underlying conditions, disease severity, time since symptom onset, and local influenza activity, and antiviral treatment should be started as soon as possible after illness onset, without waiting for a definitive influenza test result, as early therapy provides the best outcomes 1.

From the FDA Drug Label

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)]. 8. 8 Use in Patients with Chronic Conditions Efficacy of oseltamivir phosphate in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease was evaluated in one randomized, placebo-controlled clinical trial Efficacy in this population, as measured by time to alleviation of all symptoms, was not established, but no new safety signals were identified [ see Clinical Studies (14.1)].

The actual benefits of Tamiflu (Oseltamivir) include:

• Reduced symptom duration in pediatric patients 1 year to 12 years of age with influenza, as demonstrated in a double-blind, placebo-controlled trial 2
• Prophylaxis of influenza in pediatric patients 1 year to 17 years old, as established by clinical trials 2 and 2 However, efficacy has not been established in certain populations, such as:
• Pediatric patients with asthma 2 weeks to less than 1 year of age
• Patients with chronic cardiac disease and/or respiratory disease, as measured by time to alleviation of all symptoms
• Immunocompromised patients 2 and 2

From the Research

Benefits of Tamiflu (Oseltamivir)

• Reduces the duration of symptomatic illness by up to 1.5 days and the severity of illness by up to 38% compared with placebo when initiated within 36 hours of symptom onset 3
• Reduces the incidence of secondary complications and the use of antibacterials in patients with influenza 3
• Effective in the treatment of children with influenza, and may also be of use in high-risk populations such as the elderly or those with chronic cardiac or respiratory disease 3
• Demonstrates efficacy when used for seasonal or household prophylaxis, preventing the development of naturally acquired influenza by >70% compared with placebo in unvaccinated otherwise healthy adults 3
• Reduces the time to alleviation of illness by 19% compared with placebo, and returns patients to normal health status, regains ability to perform usual activities, and regains normal sleep patterns significantly faster than placebo recipients 4
• Reduces the median duration of troublesome influenza symptoms, such as fatigue by 29% and myalgia by 26% 4
• Shortens the median duration of acute febrile illness in patients with cardiac disease or chronic obstructive airways disease 4
• Proven to be safe and effective for the prevention or treatment of all known influenza subtypes, reducing the severity and duration of symptoms, the complications arising from influenza infection, and mortality 5
• Effective against pandemic strains of influenza, including the currently circulating strain (H5N1) 5
• Early administration of oseltamivir increases the benefits of influenza treatment, reducing the total median illness duration by 74.6 h (3.1 days; 41%) more than intervention at 48 h 6
• Reduces the frequency of secondary illnesses and exacerbation of underlying conditions, and improves survival in seriously ill patients who are hospitalized with severe influenza 7
• Generally well tolerated, with a similar adverse event profile to placebo, and resistant viruses are isolated with a low frequency during oseltamivir treatment 7