Asthma sufferers could be risking their lives by using drugs that treat the most severe forms of the disease, doctors warned yesterday.
Around half a million asthmatics using the medication may increase the chance of severe attacks and death, they claimed.
The two child health specialists also claimed the drugs are being given to children against current guidelines.
Call for warnings
Dr Vassilis Vassiliou and Dr Christos Zipitis, from Addenbrooke’s Hospital, Cambridge, called on the European medicines watchdog to warn against the drugs.
Writing in the Journal of the Royal Society of Medicine, the medics expressed fears about the drugs saleterol and formoterol.
However, asthma experts said doctors were aware of potential problems when prescribing the drugs.
And they said death rates from asthma have gone down since the medicines were introduced in the 1990s to treat sufferers with severe forms of the disease.
Three-fold rise in risk
But a trial showing a three-fold rise in risk of death for asthmatics using salmeterol was followed by a U.S. study of more than 26,000 patients by makers GlaxoSmithKline.
The Salmeterol Multicentre Asthma Research Trial (SMART) began in 1996, but was halted in 2003 after early analysis showed more respiratory-related deaths among those on salmeterol than existing asthma medication, 24 deaths versus 11 deaths.
There were also 13 asthma-related deaths among patients on the drug compared with three deaths in those taking other medication.
Dr Vassiliou said the role of these types of drugs – known as long-acting beta-agonist drugs (LABA) – should be urgently reviewed by the European Medicines Agency.
Doctors should be encouraged to follow good practice guidelines and never prescribe them on their own but always with inhaled steroids, he said.
He said: “We are seeing an increasingly worrying trend where chronic asthma sufferers, mainly children, are being treated solely by LABA drugs.
“LABA on its own is not safe and this monotherapy is neither supported by current evidence nor encouraged by the current British Thoracic Society guidelines,” he added.
Millions of sufferers
More than five million Britons suffer asthma, including 1.4 million children, and the disease causes 70,000 hospital admissions and 1,400 deaths each year.
But Professor Martyn Partridge, chief medical adviser at Asthma UK, said patients did not need to change their drugs as doctors were aware of potential problems when prescribing these drugs. He said the editorial in the journal was not a new study.
It had looked at previous research which gave the “impression of multiple new studies all showing the same thing, which is not actually what is happening” he said.
“This is certainly a situation where we ‘must watch this space’.
Although inhaled steroids are the most effective medicine for asthma patients, LABA drugs could help when steroids failed to fully control the condition, he said.
He said: “The report of adverse effects with long acting inhaled beta agonists is not new and there was a statistically non significant excess of deaths in those on salmeterol in the original post marketing surveillance study a decade or so ago.
“Some excess risk may reflect genetic or racial differences not yet taken into account in clinical trials, and some reflects monotherapy, which could mean those with socio-economic deprivation are taking the salmeterol and not the inhaled corticosteroid.”
He said British Asthma Guidelines did not recommend using LABA drugs alone, and believed there was no need to send all patients needing them to a specialist.
“The British Asthma Guidelines review their recommendations in a rolling and dynamic manner. Any new studies will be carefully considered and will be taken into account in the annual review.”
A spokesman for GSK said the SMART study findings were issued three years ago.
He said: “There has been an ongoing review by the European regulatory authorities which will mean that warnings already present saying the drugs should only be used with inhaled steroids are re-emphasised, which we welcome.
“The review appears to suggest deaths have risen, but since the introduction of LABAs the death rates from asthma in the UK have gone down.”
Inhaled steroids and LABAs are two separate drugs and should be taken together. Both children and adults may be prescribed LABAs.
Around 500,000 asthma sufferers have severe asthma which is hard to control.