Startseite
Impressum
Datenschutz
 
arznei-telegramm 2010; 41: 129

 


Syncope and angioedema on agomelatine (VALDOXAN): A 42-year-old woman was taking the melatonin agonist agomelatine (VALDOXAN; a-t 2009; 40: 43-4) for depression. From the second day of doing so, her face swelled up, she vomited several times and developed headaches. When she stopped the medicine, the symptoms subsided (NETZWERK report 15.608). After taking the drug for two days, a 54-year-old woman felt very dizzy and sick, blacked out, and collapsed without losing consciousness (presyncope), but was treated as a medical emergency and kept in hospital for a day for observation (NETZWERK report 15.665). The Federal Institute for Drugs and Medical Devices (BfArM) has received a total of 175 reports of suspected adverse drug reactions associated with agomelatine. Five events involved swelling of the face or tongue, which might be angioedema. Sycope was reported on four occasions (BfArM: letters dated 1 and 29 Oct. 2010). The European regulatory authority, the EMA, is reviewing five reports of angioedema and eight of syncope on agomelatine (EMA: letter dated 28 Oct. 2010). Dizziness is a common side effect of the melatonin agonist. Syncope and angioedema are not yet listed as adverse drug reactions in the Summary of Product Characteristics (Servier: VALDOXAN Summary of Product Characteristics dated Aug. 2010).



© arznei-telegramm 12/10