a-t 2015; 46: 68

Pancreatitis with roflumilast (DAXAS): A 60-year-old patient with chronic obstructive lung disease received the phosphodiesterase (PDE)-4 inhibitor roflumilast (DAXAS; a-t 2015; 46: 37, among others) as adjunct therapy. After 5 days of treatment, the patient suffered an acute episode of a pre-existing chronic alcoholic pancreatitis - with improvement following discontinuation of the PDE-4 inhibitor (NETZWERK report 16.786). In the Phase III studies performed in the context of regulatory approval, acute inflammation of the pancreas was observed more frequently with roflumilast than with placebo (0.3% vs. < 0.1%). Two patients in the study programme died of acute pancreatitis under treatment with the PDE-4 inhibitor (1). In 2014 the WHO reported eight patients - four from the USA and four from Europe - with pancreatitis suspected to have been caused by roflumilast. In five patients the symptoms improved after stopping treatment; in one patient the symptoms re-occurred after treatment was started again. One patient died, but the cause of death was not disclosed (2). It is possible that this is a rare but dangerous side effect of roflumilast that could become more important given the ever-increasing rates of prescription of this medicine and which should be included in the German summary of product characteristics. In the US product information (3), acute pancreatitis is mentioned as a serious adverse effect, -Ed.