FDA approves Roche's Tamiflu for infants with new flu symptoms
Key points
- Food and Drug Administration on Friday expanded the use of Tamiflu, the flu drug from Roche, to children as young as two weeks old who have shown flu symptoms for no more than two days.
- The FDA said the drug cannot be used to prevent flu infection in this age group.
- Tamiflu was approved in 1999 and is distributed in the United States by Genentech, part of Roche.
- The FDA said its expanded use is based on extrapolating data from previous study results in adults and older children, and supporting studies by the U.S.
The U.S. Food and Drug Administration on Friday expanded the use of Tamiflu, the flu drug from Roche, to children as young as two weeks old who have shown flu symptoms for no more than two days.
The FDA said the drug cannot be used to prevent flu infection in this age group. The drug is currently approved as both a flu treatment and preventative flu drug for children ages 1 and older, and adults. It aims to help lessen the length and severity of the flu.
Tamiflu was approved in 1999 and is distributed in the United States by Genentech, part of Roche. It was co-developed by Gilead Sciences. Its most common side effects include vomiting and diarrhea.
The FDA said its expanded use is based on extrapolating data from previous study results in adults and older children, and supporting studies by the U.S. National Institutes of Health and Roche.
Tamiflu, which had peak sales of $3 billion in 2009 because of the H1N1 swine flu epidemic, is approved by regulators worldwide but some researchers claim there is little evidence it works and have asked Roche to hand over data so they can study its effectiveness.
(Reporting By Caroline Humer; Editing by Grant McCool)
###
Reuters
Written and revised by
David Cohen, M.D.
Our doctors write and review articles for accuracy and keep them up to date.
health.am provides general information, not medical advice. Always consult a qualified health professional about your own health.
Explore health topics
More in this topic
Children's Health →
NewsFor kids with ADHD, regular 'green time' is linked to milder symptoms
A study of more than 400 children diagnosed with Attention Deficit Hyperactivity Disorder has found a link between the children's routine play settings and the severity of their symptoms, researchers report. Those who…
16 September 2011
NewsTeething an unlikely cause of serious symptoms
High fevers and other potentially serious symptoms in infants should not be written off as normal signs of teething, according to a new study. The study, which followed 47 infants over eight months, found that teething…
10 August 2011
NewsInfants learn to transfer knowledge by 16 months, study finds
Researchers have identified when an important milestone in infants' development occurs: the ability to transfer knowledge to new situations. In a series of studies, the researchers found that 8-month-olds had trouble…
