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Acute serious hormone deficiency associated with high doses of inhaled asthma drug

November 25, 2002

High doses of the inhaled corticosteroid fluticasone, prescribed as Flixotide or Seretide, to treat asthma, have been linked to acute adrenal gland malfunction, resulting in coma and convulsions. Most of those affected were children.

The findings are taken from an audit of almost 3,000 consultant paediatricians and adult endocrinologists across the UK, the results of which are reported in the current issue of Archives of Disease in Childhood.

Just 709 out of the 2,912 questionnaires were returned, giving a response rate of 24%, suggesting that the results may be an underestimate of the true picture, say the authors.

The adrenal glands sit on top of each of the kidneys. They produce hormones that help regulate heart rate, blood pressure, the way the body uses food and other vital functions.

Twenty eight children and five adults conformed to a diagnosis of adrenal crisis in association with inhaled steroids prescribed for asthma. Twenty three of the children, aged between 3 and 10, developed a sudden sharp drop in blood sugar (hypoglycaemia), leading to decreased levels of consciousness, or coma, and/or convulsions. One child with coma and convulsions died. Five children and four of the adults became lethargic, dizzy, and/or nauseous. One adult had convulsions.

Fluticasone, which was introduced in 1993 as a potentially safer alternative to other inhaled steroids, accounts for the smallest proportion of these prescriptions in the UK. Yet the drug had been prescribed in almost all (94%) of the 33 cases of adrenal crisis.

Between 500 and 2000 mg/day of inhaled corticosteroids had been prescribed in all patients who succumbed to adrenal crisis. Current guidelines recommend doses of up to 1000 mg/day fluticasone for severe asthma in children aged 5 and older. But the drug is only licensed for use in doses of up to 400 mg/day in children.

An accompanying editorial by Professor George Russell of the Royal Aberdeen Children’s Hospital says that the manufacturers have never advocated the use of such high doses, and that most doctors have become complacent about using high doses, especially in children.

Fluticasone readily permeates fat cells (lipophylic), he writes, which explains both its success as a treatment, and its potent systemic and cumulative effects. Three-quarters of those badly affected had been on high doses for a year or more.

The authors warn that it is dangerous to suddenly stop taking fluticasone, as this could precipitate adrenal crisis, emphasising that there is no evidence that the dose recommended by the manufacturers is harmful.

But in the light of their findings, they conclude that this dose should not be exceeded, unless treatment is being supervised by an expert in problematic asthma.

British Medical Journal (BMJ)