The European Medicines Agency (EMA) has started a review of inhaled corticosteroid-containing medicines used to treat chronic obstructive pulmonary disease (COPD). COPD is a long-term inflammatory disease of the lungs in which the airways and air sacs in the lungs become damaged or blocked. Corticosteroids are widely used in the European Union (EU) to treat COPD and are usually taken by inhalation using an inhaler device.
The review of inhaled corticosteroid-containing medicines has been requested by the European Commission to evaluate the risk of pneumonia (inflammation of the lungs) when these medicines are used for COPD. The risk of pneumonia with these medicines is known and was first identified in 2007 when a study showed that patients treated with an inhaled corticosteroid, fluticasone, were at higher risk of developing pneumonia than those given placebo (dummy treatment)*. Since then, new studies of individual inhaled corticosteroids and combined study results (meta-analyses) on the class of inhaled corticosteroids have provided further data on the risk of pneumonia and it was considered necessary that a thorough review be performed to further characterise this risk.
EMA will now review all available data on the risk of pneumonia with inhaled corticosteroids for COPD and consider the need to update the existing prescribing advice across the EU.