Tamiflu Approval Expanded to Include Infants Under Age 1
FRIDAY Dec. 21, 2012 -- The U.S. Food and Drug Administration has expanded its approval of Tamiflu to include children as young as 2 weeks old who have shown symptoms of flu for two days or fewer, the agency said Friday.
Tamiflu was first approved in 1999 for adults who showed symptoms of flu for no longer than two days. It was since approved to prevent flu in people aged 1 year and older.
Adults with weakened immune systems and children are at greater-than-average risk of developing complications from the influenza virus, the FDA said, citing the U.S. Centers for Disease Control and Prevention.
The most common side effects of Tamiflu among young children have included vomiting and diarrhea. Rare cases of severe rash, skin reactions, hallucinations and abnormal behavior also have been reported, the FDA said.
Tamiflu is not a substitute for the annual seasonal flu vaccination, the agency stressed. The product is produced by Genentech, based in South San Francisco.
The FDA has more about drugs to treat or prevent flu.
Posted: December 2012