An EMA Pharmacovigilance Risk Assessment Committee (PRAC) review of published data from controlled clinical trials, observational studies, and meta-analyses has concluded that all inhaled corticosteroid (ICS) products appear to carry a similar risk of pneumonia when used to treat COPD patients but that the benefits of ICS treatment for COPD outweigh the risks. Clinicians should be aware of pneumonia risk and keep an eye out for symptoms but should continue to prescribe ICS, the agency said.
According to the EMA, the review found that the risk of pneumonia in COPD patients using ICS ranged from 1-10 in 100. The agency also noted that, “There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.”
The PRAC recommended that product information for all inhaled corticosteroid products should be updated to reflect current data about risk of pneumonia, and its opinion has been adopted by the Committee for Medicinal Products for Human Use (CHMP).
Read the EMA press release.
