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arznei-telegramm 2012; 43: 106

 


Angioedema with tadalafil (CIALIS): A woman bought the impotence product LIFTA, which contains the active substance tadalafil (CIALIS), in a pharmacy in Turkey for her partner. After taking it for the first time, the 59-year-old diabetic experienced acute life-threatening angioedema of the tongue and had to spend several days in intensive care on artificial ventilation. During the two-and-a-half-week stay in hospital, his tongue swelling was slow to subside. The patient's speech was initially slurred and he had difficulty swallowing. Whereas the hospital doctors assumed infection-related angioedema, the reporting internal medicine specialist suspected a link with tadalafil (NETZWERK report 16.208). To rule out the possibility of a counterfeit medicine, we had the LIFTA tablets tested. The Central Laboratory of German Pharmacists confirmed the declared active substance content of 20 mg. Chromatographic analysis produced no evidence of unknown ingredients (Central Laboratory test report dated 23 Nov. 2012). Occurrences of angioedema on the impotence product in a post-marketing periodic safety update report from Lilly, the supplier of CIALIS, to the European Medicines Agency (EMA) were striking (EMA: CIALIS - Procedural steps taken and scientific information after the authorisation, 19 July 2012). For this reason, the CIALIS Summary of Product Characteristics (SPC) has listed angioedema as a rare unwanted effect since November 2012 (Lilly: CIALIS SPC, as at Nov. 2012).



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