Inhaled and nasal corticosteroids: Factors affecting the risks of systemicadverse effects

There has been increasing concern in the medical literature about the safet y of inhaled and nasal corticosteroids, since many patients, both adults an d children, are increasingly prescribed these drugs for the long-term proph ylactic treatment of asthma and rhinitis. It is well recognised that system ic absorption occurs following inhaled and nasal administration of corticos teroids, but the dose at which clinically relevant side effects occurs is c ontroversial. The controversy stems from the fact that the degree of system ic absorption depends not only upon the prescribed dose, but also upon the mode of delivery and the severity of the underlying disease. From a regulat ory view, it is essential that the Product Information (Summary of Product Characteristics and Patient Information Leaflet) reflects the available evi dence to enable a doctor to make an informed decision when prescribing thes e medicines. This article assesses the potential for inhaled and nasal cort icosteroids to cause systemic adverse effects by analysing the published li terature and spontaneously reported suspected adverse drug reactions report ed to the Committee on Safety of Medicines and Medicines Control Agency. Fi ve main areas of concern were reviewed: hypothalamic-pituitary-adrenal axis suppression, osteoporosis or changes in bone mineral density, growth retar dation in children, cataracts, and glaucoma. Conclusions regarding these si de effects at licensed doses of inhaled and nasal corticosteroids are reach ed and the clinical relevance is discussed, particularly following long-ter m therapy. The recommendations of the Committee on Safety of Medicines and Medicines Control Agency are included. Crown Copyright (C) 1999 Published b y Elsevier Science Inc.