Sun Times: Focus: Sick children pay high price for use of adult drugs
From: Sufaud (sufaud_at_hotmail.com)
Date: 09/12/04
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Date: 11 Sep 2004 20:15:54 -0700
The Sunday Times (London)
September 12, 2004
Focus: Sick children pay high price for use of adult drugs
Doctors are using adult medicines to treat children — often with
tragic results, writes Camillo Fracassini
DRESSED in a white tutu, Emma Frame smiles as she dances across the
stage in a grainy home video shot when she was a pretty five-year-old.
A few months after the video was made she died when she was prescribed
a huge dose of a powerful steroid — up to 10 times above the maximum
safe level set when the drug was licensed.
Emma, who had been taking the drug for 3Å years, suffered a fatal drop
in her blood sugar level. A month later her brother Callum, 7, who had
been taking the same drug, was taken to hospital suffering from the
same symptoms. He spent three days on a ventilator in intensive care
before his life was saved by an emergency operation.
Emma's parents claim they were never warned of the risks associated
with the off-licence use of the drug and were only told that their
children's growth might be stunted.
However, it has emerged that five years before Emma died in 2001
doctors had given a warning that Flixotide, one of the most commonly
used asthma inhaler medicines, could kill children in high doses.
"Emma's death was the worst thing that could ever happen to a parent,"
said her father Stewart at the family home in Strathaven, Lanarkshire.
"It is impossible to explain how we felt, having lost our daughter, to
have our son in intensive care knowing there was a very high
possibility that he would die."
Each year 900 children in Scotland are admitted to hospital because
they have suffered adverse reactions to prescription medicines. Many
cases are due to "off-label" prescribing by doctors who give medicines
to patients outside the terms of the drugs' licences.
Doctors are allowed to prescribe adult medicines for children and
determine the dosage because few children's drugs have been tested and
approved by the government's Medicines and Healthcare Products
Regulatory Agency.
About 40% of the drugs used in paediatric medicine are not licensed
for children. For infants the figure is 65%. Because children absorb
drugs in a different way to adults, side effects are often unknown.
"If medicines are used off- label in children then the frequency of
adverse drug reactions is higher and these can range from a minor skin
rash to death," said Dr James McLay, a clinical pharmacologist at
Aberdeen University.
Many doctors accuse the pharmaceutical industry of dragging its heels.
Without legislation forcing firms to conduct clinical trials on
children, there is no incentive for them to undertake the expensive
and time consuming tests.
Concern over the lack of licensed medicines for children was addressed
in America 10 years ago. The US government offers drug firms financial
incentives and extended patents to test drugs on children. The
European Union is to offer similar incentives, but not until 2006.
Last month the Department of Health said it intends to publish a book
to advise doctors which medicines should be given to children. It will
also promote research into such drugs. The Scottish executive is
understood to have committed money to the project.
A spokesman for GlaxoSmithKline (GSK), the manufacturer of Flixotide,
said: "The safety profile of Flixotide within licensed doses is well
established and it has been used to treat more than 250,000 children
in the UK. It's also the most widely used inhaled corticosteroid in
severe asthma.
"GSK does not and cannot promote out-of-licence use of its medicines,
but we recognise that in certain instances asthma experts may be faced
with very difficult clinical decisions about the most appropriate dose
of medicine needed to treat a serious disease."
http://www.timesonline.co.uk/newspaper/0,,176-1258046,00.html
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