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The risk of pneumonia associated with the use of inhaled corticosteroids by patients with chronic obstructive pulmonary disease (COPD) is outweighed by the benefits of treatment, according to the findings of a safety review by the European Medicines Agency (EMA).
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which carried out the review, could not establish whether the risk is different for different inhaled corticosteroids, but concludes that pneumonia is a common side effect for all types.
The committee recommends that product information should be updated to reflect current evidence and knowledge about pneumonia risk associated with use of inhaled corticosteroids in COPD. It says the drugs should continue to be prescribed as usual but that doctors and patients should look out for signs of pneumonia, especially as the symptoms are similar to the underlying disease.
The recommendations, which were published following a PRAC meeting held on 14–17 March 2016, now go to the EMA’s Committee for Medicinal Products for Human Use for approval before they become official policy.
