EMA has completed a review of the known risk of pneumonia (lung infection) in patients who take inhaled corticosteroid medicines to treat chronic obstructive pulmonary disease (COPD). COPD is a long-term disease of the lungs in which the airways and air sacs in the lungs become damaged or blocked, leading to breathing difficulties. Corticosteroid inhalers are widely used in the European Union (EU) to treat COPD and pneumonia is a common side effect of such treatment.
The review confirmed the risk of pneumonia with these products, which has been known for many years, and that it is common (can affect between 1 and 10 COPD patients in 100 using these medicines). The review did not find any conclusive evidence of differences in this risk for different products.
Overall the benefits of inhaled corticosteroid medicines in treating COPD continue to outweigh their risks and there should be no change to the way in which these medicines are used. Patients with COPD and their doctors should however be alert for signs and symptoms of pneumonia, bearing in mind that the clinical features of pneumonia overlap with those of a worsening (exacerbation) of the underlying disease.
The review was carried out by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which recommended that the product information for these medicines should be updated to adequately reflect current knowledge about the risks. The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which has now adopted the Agency’s opinion.