Antiviral drug oseltamivir appears safe and effective for infants hospitalized with influenza: Study

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Given promptly, the antiviral drug oseltamivir (Tamiflu) appears safe and effective for infants hospitalized with influenza, reports a study in the June issue of The Pediatric Infectious Disease Journal. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.

Although formal studies are still needed, oseltamivir seems to work as well in infants as in older children with influenza, according to Drs. Kai Siedler of Klinikum Worms and Heino Skopnik of University Children's Hospital, Mannheim, Germany.

Prompt Fever Reduction, Few Serious Complications with Oseltamivir in Infants
The researchers evaluated the effects of oseltamivir in 157 infants treated at Dr. Siedler's hospital over five influenza seasons, 2003 through 2007. The average age was six months. All infants were given oseltamivir within 48 hours after initial flu symptoms, and most within 24 hours. (Oseltamivir is most effective when given within 48 hours.)

All of the infants had fever along with other symptoms of influenza, such as runny nose, sore throat, and cough. The symptoms were generally similar to those in older children with the flu—the exception was a higher rate of gastrointestinal symptoms (vomiting and diarrhea) in infants.

As in older children, oseltamivir seemed highly effective in reducing fever in infants with influenza. Body temperature returned to normal within 36 hours after the start of treatment in 82 percent of babies, and within 48 hours in 87 percent.

About half of the infants had some type of complication, although most were not serious. Many of the infants developed feeding problems, often requiring intravenous fluids. A few needed antibiotics for secondary bacterial infections.

More Research Needed to Evaluate Antiviral Drugs for Infants
Oseltamivir has been recommended for treatment and prevention of influenza in children who are 1 to 12 years of age, as well as in adults. With the emergence of pandemic 2009 influenza A H1N1, oseltamivir was approved in Europe for use in infants under age one. In the United States, oseltamivir has been authorized for use in infants on an emergency basis.

Especially since the emergence of H1N1, doctors and parents need to know whether oseltamivir is safe and effective for infants with influenza. This is especially important since influenza vaccination is not recommended for infants less than six months old—who are at higher risk of hospitalization and death if they do develop influenza. Experience in the first year of the H1N1 influenza pandemic suggests that prompt treatment with antiviral medications like oseltamivir improves the chances of good outcomes.

This experience at a major German hospital suggests that oseltamivir is also safe and effective in infants with influenza. Compared to studies in older children, "Oseltamivir has an acceptable tolerability profile and seems efficacious for the treatment of influenza in infants less than 1 year old," Drs. Siedler and Skopnik conclude. However, they emphasize that formal studies of oseltamivir for infants with influenza, including H1N1, are still needed.

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