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News2014October › Asthma drugs for children more dangerous than safety trials had suggested › October 2014

Asthma drugs for children more dangerous than safety trials had suggested

Asthma drugs for children are more dangerous than regulators had believed-because the safety trials had been carried out on young healthy adults

Asthma drugs for children are more dangerous than regulators had believed-because the safety trials had been carried out on young healthy adults. Almost all the adverse reactions seen in children are 'serious', say researchers.

The real risks of the drugs when used by children came to light only when reports were added to the new safety tracking system, EudraVigilance, set up by the European Medicines Agency.

In total, 774 ADRs (adverse drug reactions) relating to asthma drugs have been reported to the system, and 85 per cent of them are considered to be 'serious'.

Almost none of the reactions had been recorded during the drugs' safety trials, but as researchers from the University of Copenhagen point out, these had involved healthy young adults.

It's been a different story when the drugs have been taken by babies and small children. Common ADRs have included breathlessness and coughing.

Safety trials had recorded 'non-serious' ADRs, although the Copenhagen researchers discovered that subjects who had suffered more serious effects had suddenly dropped out of the trials, and so their reactions had never been recorded.

(Source: International Journal of Clinical Pharmacy, 2014; doi: 10.1007/s11096-014-0020-0)


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