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arznei-telegramm 2012; 43: 56

 


Erectile dysfunction under esomeprazole (NEXIUM, generics): After taking esomeprazole (NEXIUM, generics) for several months, a 51-year-old man with reflux esophagitis complains about impotence persisting for several weeks. After discontinuing the proton pump inhibitor, sexual function normalises again (NETZWERK-Bericht 16.120). Eleven years ago, we already reported our suspicion that proton pump inhibitors may cause erectile dysfunction (a-t 2001; 32: 47, 5 reports). So far, we have received twelve reports of such suspected cases. The German Federal Institute for Drugs and Medical Devices (BfArM) has received 18 reports from within Germany (BfArM: letter dated May 16, 2012). The Dutch pharmacovigilance centre Lareb has documented 25, the British MHRA 92 reports on erectile dysfunction; they affect all derivatives approved in Germany (see http://www.lareb.nl and http://www.mhra.gov.uk). Most of the submitted suspected cases involve omeprazole (ANTRA, generics), which is probably prescribed most frequently since it is the oldest proton pump inhibitor and has been tested most extensively. The information provided in Summaries of Product Characteristics (SPCs) or pharmacopoeias vary from country to country: US SPCs list impotence as an adverse effect for esomeprazole and lansoprazole (AGOPTON, generics) and the British National Formulary for lanzoprazole and omeprazole (BNF 63; March 2012; page 56). In German SPCs, this information is still only included for lansoprazole (e.g., Takeda: AGOPTON SPC, as of Oct. 2010).



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