Corticosteroid Benefits for COPD Outweigh Pneumo Risk: PRAC


March 18, 2016

The benefits of inhaled corticosteroids in treating chronic obstructive pulmonary disease (COPD) continue to outweigh the increased risk for pneumonia, European Union (EU) regulators announced today.

Furthermore, this risk appears to be the same for all drugs in this class.

Regulators on both sides of the Atlantic for years have noted the increased risk for pneumonia for inhaled corticosteroids such as fluticasone and budesonide. In May 2015, the European Medicines Agency (EMA) announced that new studies of these drugs as well as meta-analyses of older ones warranted a "thorough review" of the risk for pneumonia in COPD treatment. That job fell to the agency's Pharmacovigilance Risk Assessment Committee (PRAC).

Yesterday, PRAC delivered its conclusions: Patients with COPD who use inhaled corticosteroids do run a higher risk of acquiring pneumonia. "However the Committee's view is that the benefits of inhaled corticosteroids continue to outweigh their risks," the EMA said in a news release. PRAC also did not find any conclusive evidence that the risk for pneumonia varied among inhaled corticosteroids.

PRAC recommended updating product information for inhaled corticosteroids, but the committee saw no need to change the way these medicines are used, other than to remind clinicians and patients with COPD to look for signs and symptoms of pneumonia.

The committee's recommendations now go to the EMA's Committee for Medicinal Products for Human Use for a final opinion. More information on the PRAC review is available on the EMA website.


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