Experts have raised concerns over the drugs Salmeterol and Formoterol, calling on the EMEA ( European Agency for the Evaluation of Medicinal Products ) to warn against this class of asthma drugs on new evidence which shows they have the potential to increase severe asthma episodes and deaths.

Writing in the Journal of the Royal Society of Medicine ( JRSM ), Vassiliou1 and Zipitis argue that the current role of long acting beta-agonist drugs, which are known as LABA and include Salmeterol and Formoterol, should be reviewed. In addition they argue that LABA should not be used on their own.

Salmeterol ( Serevent ) and Formoterol ( Foradil ) are commonly prescribed in the treatment of asthma.

" We are seeing an increasingly worrying trend where chronic asthma suffers, mainly children, are being treated solely by LABA drugs” said Vassilis Vassiliou from Addenbrooke’s Hospital, Cambridge .

" LABA on its own is not safe and this monotherapy is neither supported by current evidence nor encouraged by the current British Thoracic Society ( BTS ) guidelines ."

In the UK, asthma affects more than 5 million people, leads to around 70,000 hospital admissions and causes 1,400 deaths each year. Usually prescribed for sufferers with severe forms of the disease, Salmeterol is appealing because its effects are long-lasting and allows for twice daily administration.

Vassiliou and Christos Zipitis from Burley General Hospital, Burley, examined the results of the Salmeterol Multicenter Asthma Research Trial ( SMART ) undertaken by GlaxoSmithKline ( GSK ) which compared the addition of Salmeterol or placebo to existing asthma medication amongst 26, 355 patients.

SMART was halted in 2003 following interim analysis that showed there were more overall respiratory-related deaths ( 24 versus 11 ) and asthma-related deaths ( 13 versus 3 ) amongst patients on Salmeterol.

"The Food and Drug Administration warned in July last year that Salmeterol may be associated with rare serious asthma episodes or asthma-related deaths and it is crucial the European Medicines Agency follow," said Vassilis Vassiliou.

" While there is provision in the BTS guidelines for LABA drugs to be discontinued if they are not deemed useful after a trial period, this is not being reinforced.

" It is critical that current evidence on asthma drugs is incorporated in clinical practice," he said.

Source: Journal of the Royal Society of Medicine, 2006


XagenaMedicine2006