FDA Approves Tamiflu for Infants

ByJennifer Warner
WebMD Health News Reviewed byBrunilda Nazario, MD

Dec. 21, 2012 -- Children as young as 2 weeks old may now be treated for the flu with Tamiflu.

The FDA expanded its approval today for Tamiflu to include infants under age 1 who have had symptoms of the flu, such as stuffy nose, cough, sore throat, fever, and body aches, for no longer than two days.

It is not approved to prevent flu infection in this age group.

Tamiflu is now the only drug approved to treat the flu in children under age 1, who are at higher risk of developing complications of the flu.

Until now, Tamiflu was approved to treat the flu in adults and children ages 1 year and older who have had symptoms for less than two days. The drug is also approved to prevent flu infection in children and adults over 1 year of age.

Correct Dosing for Infants Essential

FDA officials say there is a fixed dosing schedule for children and adults over age 1, but dosing for children under 1 year old must be calculated for each infant according to their weight.

Children under age 1 should receive 3 milligrams of Tamiflu per kilogram of body weight twice daily for five days. This smaller dose requires a different dispenser than what currently comes in the Tamiflu package.

“Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. “Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight.”

Infants at Risk for Flu Complications

According to the CDC, children younger than 2 years old are especially vulnerable to developing complications from the flu. Infants 6 months of age and younger have the highest rates of hospitalization for the flu.

The FDA based its approval of Tamiflu for children under age 1 on data from previous studies in adults and older children.

Two new safety studies in 135 children under 1 year old with confirmed cases of the flu also showed the safety profile in infants was consistent with that found among older children and adults.

The most common side effect in these studies was vomiting and diarrhea.

Rare cases of severe rash, skin reactions, hallucinations, delirium, and abnormal behavior have been reported with use of Tamiflu but were not found in these new safety studies.

View Article Sources

SOURCES:

FDA.

News release, FDA.

WebMD Drug Information from First DataBank: “Tamiflu Oral.”

© 2012 WebMD, LLC. All rights reserved. #url_reference {display: none};#url_reference { display: block; line-height: 150%; margin-bottom: 10px; }#logo_rdr img { visibility: visible; }.titleBar_rdr .titleBarMiddle_fmt { padding-top: 1.5em !important;} Top Picks 10 Foods to Eat When You Have the Flu Is It a Cold or Is It the Flu? Flu Shots and Side Effects Top Items for Allergy Relief 15 Immune Boosting Super Foods Anatomy of a Sore Throat Cold, Flu, & Cough Health Center Cold Flu Cough Community News & Features Reference Videos Flu Questions and Answers Glossary Medications See what others are asking about

Visit WebMD Answers

Related to Cold, Flu, & Cough Cough Syrup Abuse Ear Infection Flu Vaccine Living Healthy Map: Cold & Flu Severity Sinus Infection Sinus Symptom Evaluator Strep Throat Today in Cold, Flu, & Cough Slideshow Nasal Irrigation Pros & Cons Slideshow Flu? 10 Foods to Eat   Slideshow Best Natural Cold & Flu Remedies TOOL Keep Track of Your Vaccinations   Slideshow Best Natural Cold & Flu Remedies Video The Truth About Snot   Health Check Sinus Issues? Get Personalized Tips Article Inside an Ear Infection   Article Flu Vaccine: Do You Really Need It? Video Bacterial or Viral Infection?   Quiz How to Calm Your Cough Slideshow Anatomy of a Sore Throat   Subscribe to WebMD Newsletters

WebMD Daily Women's Health Men's Health Weight Loss Wisdom I have read and agree to WebMD's Privacy Policy. Submit Sign up for more topics! WebMD Special Sections Cold and Flu Remedies: What Works? Colds, Cough & Sore Throat Finding Relief for Your Cough Health Tips for Cold and Flu Season How to Treat Cold and Flu Symptoms Is It a Cold? Or Is It the Flu? Natural Cold and Flu Remedies Slideshow: Is It a Cold or Is It the Flu? Slideshow: Tips to Survive Cold & Flu Season WebMD: Cold and Flu Symptoms Across the Nation Health Solutions From Our Sponsors Vaccine Questions? Low Testosterone? Diabetes Care for Kids Birth Control for Moms Blood Sugar Control Advanced Prostate Cancer? Diagnosed With Low T? Fibromyalgia & Exercise Hearing Aid Alternative Insulin Pump Therapy Vaccines for All Ages Knee Pain Relief Depression & Adults Treating Fibromyalgia Relapsing MS Community In-depth coverage: Psoriasis Treatment on Target?|Healthy Mouth Help|RA Assessment|Living Healthy Guide|Family & Pregnancy Toolbox|Check Your Heartburn Symptoms Find us on:URAC: Accredited Health Web SiteHonCode: Health on the Net FoundationAdChoicesAbout WebMD Advertise With Us Terms of Use Privacy Policy Sponsor Policy Site Map Careers Contact UsMedscape Reference eMedicineHealth RxList Medscape MedicineNet BootsWebMD WebMD CorporateMedical Dictionary-->First Aid WebMD Magazine WebMD Health Record WebMD Mobile Newsletters Dictionary Physician Directory

©2005-2012 WebMD, LLC. All rights reserved.

WebMD does not provide medical advice, diagnosis or treatment. See additional information.

View the Original article