PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the known risk of pneumonia (infection of the lungs) with inhaled corticosteroid-containing medicines when used 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. Corticosteroids are widely used in the European Union (EU) to treat COPD and are usually taken by inhalation using an inhaler device.
The PRAC review confirms that COPD patients treated with inhaled corticosteroids are at increased risk of pneumonia; however the Committee’s view is that the benefits of inhaled corticosteroids continue to outweigh their risks. The PRAC also looked whether there were any differences in the risk of pneumonia between these products, and did not find conclusive evidence of such difference. Pneumonia remains a common side effect for all of them.
An update of the product information is being recommended to adequately reflect the current knowledge. There is no change to the way these medicines should be used; however, doctors and patients should be vigilant for signs and symptoms of pneumonia in patients with COPD as the clinical features of pneumonia overlap with those of exacerbations of the underlying disease.
The PRAC recommendation will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for the adoption of EMA’s final opinion. Further details including advice for patients and healthcare professionals will be published at the time of the CHMP opinion.
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