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Last Updated: Tuesday, 13 April, 2004, 05:27 GMT 06:27 UK
Concerns over asthma drug dosage
Flixotide inhaler
Flixotide is a steroid-based inhaler for treating asthma
Children in Scotland could be at risk from high dose prescriptions of a common asthma inhaler drug, a BBC investigation has found.

A fatal accident inquiry is expected into the death of Emma Frame who fell ill after being prescribed 10 times the licensed dose of fluticasone.

Doctors have admitted they do not know how many children are on such doses.

The drug is safe within recommended limits and helps thousands control what can be life-threatening asthma.

BBC Scotland's documentary programme Frontline Scotland said that concerned parents were advised to contact their GP for advice, but under no circumstances should they stop important medication.

Emma's parents, from Strathaven in Lanarkshire, want a full review of prescribing practises to make sure other children are not put at risk.

Scotland is the asthma capital of the world with one in three children having the disease.

We are the experts in manufacturing and developing medicines, the doctors are experts in treating patients and we do work very closely together
Dr David Leather
GlaxoSmithKline UK
Emma, who died when she was five, became a sufferer when she was diagnosed with the disease at the age of one after coughing at night to the point where she would vomit.

Doctors recommended she went on inhaled steroids and when she was 18-months old she was put on a new drug, Flixotide, otherwise known as fluticasone.

Her father Stewart said: "When Emma was taken to hospital, she was shaking and starting to fit.

"She was ventilated and at that point people were optimistic again, but after about an hour the doctors told us that she couldn't survive.

'Benefited patients'

"The loss of Emma was devastating and not knowing what happened at the time didn't seem important.

"The shock of losing Emma was every parent's nightmare. It is very difficult to explain how you feel at that point."

A government department, the Medicine Control Agency, looks at the evidence on the safety of new drugs.

It licenses them on what it considers to be the largest safest dose, but doctors can prescribe beyond that maximum.

Emma Frame on swing
Emma Frame died at the age of five
In the case of Emma, and her older brother Callum who was also an asthma sufferer, the dosage was 10 times the so-called "off-label" recommendation.

GlaxoSmithKline is the manufacturer of Flixotide, which generates 3bn in worldwide sales for the firm.

Dr David Leather, director of medical affairs for GlaxoSmithKline UK, said: "You have to remember that Flixotide has been out 10 years and it has benefited 250,000 patients who have had their lives dramatically improved.

"Inhaled steroids have also benefited asthmatics, asthma deaths were rising in the UK up until a decade or so ago and in the last 10 years we have seen a reduction in deaths directly because of these medicines - almost a 40% reduction in the last 10 years or so.

"We are the experts in manufacturing and developing medicines, the doctors are experts in treating patients and we do work very closely together.

"We are 100% confident about the safety profile of Floxitide within its licensed doses and we recognise that doctors have difficult decisions to make."

BBC Scotland's Graeme McAulay
"Concerned parents are advised to contact their GP"

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