The Pharmaceutical Journal Vol 267 No 7165 p347-351
15 September 2001

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Prescribing

Note inhaled corticosteroids

From Dr H. Price

We refer to your extracts from Current Problems in Pharmacovigilance published recently (PJ, 1 September, p283). Within this section, there is an item detailing the changes to prescribing information for fluticasone propionate.

We are concerned that the abbreviated information provided within your item does not adequately summarise some key points raised in the latest edition of Current Problems in Pharmacovigilance (2001;27:9–15) published by the Committee on Safety of Medicines (CSM) and the Medicines Control Agency (MCA).

The recommendations made by the CSM and MCA are clear in the context that inhaled corticosteroids provide effective control of asthma and may avoid the necessity for oral steroids in some patients. However, it is important to minimise the risk of systemic adverse effects with inhaled corticosteroids. The MCA has previously reported on warnings added to the product information for all inhaled corticosteroids with respect to their potential to cause systemic adverse effects, particularly if high doses are prescribed for long periods of time. As a result, the advice to titrate to the lowest effective dose applies equally to all inhaled corticosteroids, not just to fluticasone propionate, as implied in your item.

Your article also mentions that only specialists should prescribe fluticasone propionate at doses above 500µg twice daily. The recommendations in this instance are particular to fluticasone. However, this is due to the fact that these doses are higher in equivalent terms than the licensed doses for other inhaled corticosteroids (as a result of the higher potency of fluticasone — 2:1 versus beclometasone dipropionate and budesonide). Furthermore, the recommendations by the CSM/MCA are clear that the reference to prescription of such doses by “specialists in the management of asthma” includes general practitioners with appropriate experience, as well as consultant physicians.

We believe it is also important to note that the licensed dosage range for fluticasone remains unchanged. This review clarifies the appropriate use of high dose fluticasone in severe asthma and does not highlight the risk of systemic adverse effects for fluticasone in general.

We would be pleased if you could advise your readers of the above points and that they note that the CSM/MCA advice does not imply any new safety concerns with fluticasone propionate, but merely clarifies the use of doses higher than the equivalent of any other licensed inhaled corticosteroid in patients with severe asthma.

Helen Price
Medical Affairs Director,
GlaxoSmithKline

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