Side-effects of roflumilast

Abstract

Two articles1,2 published in The Lancet in 2009 on roflumilast for chronic obstructive pulmonary disease (COPD) describe four clinical studies (M2-124, M2-125, M2-127, and M2-128) done by the drug company that owns the patent on roflumilast. The raw data on the condition of patients who participated in the studies is not available to anyone outside of the company or the US Food and Drug Administration (FDA). Since roflumilast was approved by the FDA, new information about the side-effects has come to light, from independent analysis of these data by FDA staff physicians.