Canada. From January 1996 to the end of September 2002, Health Canada received nine reports of suspected adrenal insufficiency associated with inhaled fluticasone. In comparison, they did not receive any reports associated with inhaled budesonide or beclomethasone during this time. Of the nine reports associated with fluticasone, five involved children aged 4-13 years and, where specified, dosages ranged from 250 to 110 µg/day. In four of the cases, the fluticasone dosage was more than 1000 µg/day. Health Canada reminds clinicians that increasing the dosage of inhaled corticosteroids above a certain limit has minimal benefit and increases the risk of systemic adverse effects. Furthermore, the Canadian asthma consensus guidelines recommend that the minimum effective dose required to maintain control should be used. Health Canada also recommends that patients and parents should be advised of the risk and signs and symptoms of adrenal suppression associated with inhaled corticosteroids, and cautions of the risk of serious adverse reactions if they stop treatment abruptly.
Canadian Adverse Reaction Newsletter Vol 13, Issue 4, October 2003. Available from URL: http://www.hc-sc.gc.ca