Startseite
Impressum
Datenschutz
 
arznei-telegramm 2010; 41: 32

 


Nose bleeds due to alpha-receptor blocker tamsulosin (ALNA OCAS, generics): A 61-year-old man takes the alpha-1 antagonist tamsulosin (TAMSULOSIN AL) for prostatic hyperplasia. For the first time after four days, and several times over the next two weeks, he gets nose bleeds. When he stops taking the medication, the symptoms improve (NETZWERK report 14.771). The Dutch Pharmacovigilance Centre, Lareb, received eight reports of epistaxis with tamsulosin within a year of the start of treatment. The European EudraVigilance Database contains 15 reports of nose bleeds linked to tamsulosin. 13 are classified as serious and 10 led to hospital admission. Alpha-1 antagonists cause vasodilation and might consequently increase the risk of epistaxis (Lareb: "Tamsulosin and epistaxis", Oct. 2009; can be found at http://www.lareb.nl). The German Federal Institute for Drugs and Medical Devices (BfArM) has received two reports of men with nose bleeds while on tamsulosin; one was severe, occurred up to three times a day and was difficult to stop (BfArM: letter dated 25 Feb. 2010). In the Summary of Product Characteristics (SPC) of the alpha-receptor blockers doxazosin (CARDULAR PP URO, generics) and terazosin (FLOTRIN, generics), epistaxis is listed as an adverse reaction (e.g. Pfizer: CARDULAR PP URO SPC dated Nov. 2008; mibe: FLOTRIN SPC dated Aug. 2007); it is not, however, listed as such in the SPC of tamsulosin products such as ALNA OCAS (Boehringer Ingelheim Pharma: ALNA OCAS SPC dated Jan. 2009) or of alfuzosin products such as URION (Sanofi-Aventis: URION SPC dated March 2008).





© arznei-telegramm 3/10