EMA Assessing Pneumonia Risk With Inhaled Corticosteroids

The European Medicines Agency is taking a hard look at whether patients taking inhaled corticosteroids for chronic obstructive pulmonary disease are at higher risk for pneumonia.

The link between inhaled corticosteroids and pneumonia was first noted in a 2007 study that found patients given fluticasone had a higher likelihood of pneumonia than patients given a placebo.

A subsequent study published in the journal Thorax in August 2013 followed 163,514 patients on corticosteroids and found that 20,344 developed serious pneumonia during the 5.4 years of follow-up care.

Overall, use of inhaled corticosteroids increased the rate of pneumonia by 69 percent.

Drugs in the EMA’s crosshairs include fluticasone, Teva’s BiResp Spiromax (budesonide and formoterol), DuoResp Spiromax (budesonide and formoterol fumarate) and Vylaer Spiromax (budesonide /formoterol), and GSK’s Relvar Ellipta (fluticasone furoate/vilanterol) and Revinty Ellipta (fluticasone furoate/vilanterol).

The EMA wants companies that make these drugs to provide figures on sales and patient exposure, the risks of pneumonia and any general safety warnings, and any pharmacovigilance programs that are in place.

The agency’s Pharmacovigilance Risk Assessment Committee will look at data from the 2007 study, as well as other studies of individual drugs and the drug class as a whole, with an eye toward updating prescribing advice.

PRAC is expected to submit a list of recommendations to the Committee for Medicinal Products for Human Use in October. The committee will then make its recommendations to the European Commission, which will have the final say. — Lena Freund