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Drug regulator to probe inhaled steroids pneumonia risk

By Nigel Praities

Exclusive: The UK drug regulator has launched a major investigation into the risk of pneumonia in patients with COPD who are taking inhaled steroids, Pulse can reveal.

The move follows the publication of several large-scale studies, the latest of them last week, linking the drugs with sharply increased rates of pneumonia.

A meta-analysis of research covering 17,000 patients show-ed inhaled steroids raised the risk of pneumonia by 81% in comparison with placebo.

The UK and US study, published in the Archives of Internal Medicine, found the association remained even when steroids were combined with ß-agonist treatment, with a 68% elevated risk of pneumonia compared with ß-agonist alone.

The Medicines and Healthcare Products Regulatory Agency is now to conduct a ‘full risk-benefit review' of inhaled steroid and ß-agonist treatment in COPD, and will issue new guidance to GPs as soon as it concludes.

A spokesperson warned GPs to ‘remain vigilant for the possible development of pneumonia and other lower respiratory tract infections in patients with COPD', warning clinical features of infections and exacerbations ‘frequently overlap'.

The spokesperson added: ‘If a patient with severe COPD has experienced pneumonia, treatment with [combination treatment] Seretide should be re-evaluated.'

Dr Yoon Loke, one of the researchers on the new study and a senior lecturer in clinical pharmacology at the University of East Anglia, said the results were ‘pretty clear' and he would be meeting with the MHRA to discuss them this month.

‘GPs should check that their patients are really getting any benefit from steroid treatment, and if not then those patients should be reviewed and after a discussion they can come off the steroid,' he said.

But Dr Steve Holmes, a GP in Somerset and a member of the General Practice Airways Group, said the benefit of preventing exacerbations was likely to outweigh the risk of pneumonia.

‘There have been some concerns over the safety of inhaled steroids which require exploration. At the moment I would not recommend wholesale change, but I would recommend getting the diagnosis right and being suspicious about the causes of exacerbations,' he said.

A spokesperson for GlaxoSmithKline – manufacturer of Seretide – said combining inhaled steroids and ß-agonists remained an important treatment option for appropriately selected patients with COPD.

‘While the analysis reports an increase in the overall incidence of pneumonia in COPD patients receiving inhaled steroids, there was no increase in pneumonia-related mortality.'

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