Mar 26 2006
The U.S. Food and Drug Administration (FDA) has given approval for the use of the asthma drug Flovent HFA in children four to eleven years of age.
Flovent HFA, produced by British based drug company GlaxoSmithKline, had previously been approved only for patients 12 years of age and older.
The U.S. Centers for Disease Control (CDC) estimates nine million children under the age of 18 have been diagnosed with asthma and 3.6 million of those children are between the ages of five and 11.
According to a recent survey of children with asthma in America, 42% of children needed some form of urgent or emergency care visit for their asthma in the past year.
It was found that more than 50% of children with asthma experienced an attack so severe that immediate medical attention was required either at an emergency room or at a doctors clinic.
More than 25% of children with asthma experienced an asthma attack so severe they had to be hospitalized.
Children with asthma miss more than 12 million school days every year, making asthma the number one cause of school absences due to chronic conditions.
Flovent HFA is the most prescribed inhaled corticosteroid and will now be available in an aerosol for children aged four to eleven and is an important medicine in the treatment of asthma. The drug helps reduce inflammation in the airways.
Flovent HFA is now recommended for the maintenance treatment of asthma and as a preventative therapy in patients four years of age and older.
Dosage for pediatric patients four to 11 years of age is 88 mcg twice daily.
It is also recommended for patients requiring oral corticosteroid therapy as many may be able to reduce or eliminate their requirement for oral corticosteroids over time.
While adjusting to a switch from an oral steroid, like prednisone, to Flovent HFA, patients may be less able to heal after surgery, infection or serious injury.
Flovent HFA does not replace fast- acting inhalers for sudden symptoms.
In trials it was found that 88 mcg of Flovent HFA given twice daily improved peak expiratory flow, reduced daily rescue albuterol use, and reduced nighttime awakenings over 12 weeks in children four to 11 years of age with persistent asthma.