Food and Drug Administration
U.S. Department of Health and Human Services
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T00-35 Print Media: 301-827-6242
August 8, 2000
Consumer Inquiries: 888-INFO-FDA
FDA today approved Pulmicort Respules (budesonide inhalation suspension) for asthma in children between the ages of one to eight. Pulmicort Respules is the first anti-inflammatory corticosteroid formulated for inhalation using a nebulizer in this age group. Previously, no other inhaled corticosteroid has been approved for use in children younger than four years of age. This approval allows for treatment with an approved formulation in a significant, currently unserved pediatric asthma population.
Inhaled corticosteroids when used as maintenance therapy are effective in reducing the inflammation that often precipitates an asthma attack or bronchospasm. Improvement in asthma control following treatment with Pulmicort Respules can occur as early as two weeks, although the maximum benefit may not be achieved for four to six weeks after starting treatment.
Approval for Pulmicort Respules was based on three randomized U.S. studies of 12-weeks duration in more than 1000 patients aged six months to eight years of age. The children studied had persistent asthma of varying duration and severity.
This drug should be used once or twice a day on a regular basis, but should not be used to treat acute severe episodes of asthma. Pulmicort Respules is not a bronchodilator and is not indicated for the relief of acute bronchspasm or other acute episodes of asthma. In the case of severe or acute episodes of bronchospasm, a fast-acting inhaled bronchodilator should be used.
Studies have shown that inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. In clinical studies with a variety of inhaled corticosteroids, the mean reduction in growth velocity was approximately one centimeter per year and appears to be related to dose and duration of exposure. The potential for catch up growth has not been adequately studied.
Side effects from Pulmicort Respules during clinical trials included respiratory infection, rhinitis, and coughing. Also, children using Pulmicort Respules should avoid exposure to chicken pox and measles. If exposure occurs, and the child has not had chicken pox or been properly vaccinated, a physician should be consulted without delay.
Pulmicort Respules is manufactured by the AstraZeneca Group located in Wayne, Pa.
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