EMA Completes Review of Inhaled Corticosteriods

April 29, 2016
Pharmaceutical Technology Editors

The agency found no differences in risk of pneumonia for different products.

On April 29, 2016, the European Medicines Agency (EMA) announced the completion of the Pharmacovigilance Risk Assessment Committee’s (PRAC) review of the risk of pneumonia in patients who use inhaled corticosteroid drugs to treat chronic obstructive pulmonary disease (COPD). The PRAC review found that the risk of pneumonia is a common side effect of the treatment.

While the review confirmed the risk of pneumonia with the use of inhaled corticosteroids, EMA says the overall benefits of the treatment outweigh the risks. Therefore, patients should continue to use the drugs, but patients and doctors should be alert to potential signs and symptoms of pneumonia. EMA states that doctors and patients should be aware of the following:

  • Inhaled corticosteroids increase the risk of pneumonia. The risk applies to all medicines in this class, and the risk is the same between products.

  • Corticosteroid inhalers reduce inflammation and swelling in the lungs and help breathing in patients with COPD.

  • Symptoms of pneumonia include fever or chills, increased mucus, worsening cough, or breathing difficulties.

  • There is some evidence of increased risk of pneumonia with increase dosage of steroids, but the evidence is not conclusive.

The review included published data from randomized controlled clinical trials, meta-analyses, and observational studies. EMA states,  “no clinical trials directly examined the risk of pneumonia with ICS head to head, and only indirect comparison in meta-analyses/systematic reviews or from observational studies is available. Due to the variability in the clinical data and multiple uncertainties with study methodologies, this does not provide conclusive evidence for intra-class differences in the magnitude of risk.” The PRAC review was conducted at the request of the European Commission (EC). The PRAC results were sent to the Committee for Medicinal Products for Human Use, which will forward the results to the EC.

Source: EMA