arznei-telegramm 2003; 34: 16

 
 

Angioedema and Gyrase Inhibitors: In our NETZWERK DER GEGENSEITIGEN INFORMATION (Network of Mutual Information), an association between angioedema and ofloxacin (e.g. TARIVID) has been noted. With 10 reports of angioedema, the gyrase inhibitor is in third place among the most frequently suspected medications, following the two ACE inhibitors enalapril (e.g. XANEF, 20 reports) and captopril (e.g. TENSOBON, 16). Ofloxacin is also listed nine times as a possible cause of facial, lingual or laryngeal edema. There are also reports of edema including angioedema for ciprofloxacin (e.g. CIPROBAY, 4 reports), levofloxacin (TAVANIC, 4), moxifloxacin (AVALOX, 3), gatifloxacin (BONOQ, 3) and fleroxacin (QUINODIS, 1). About eight hours after taking gatifloxacin for the first time, a 79 year-old woman awoke because of swelling of her tongue, pharynx and larynx. The rapidly increasing symptoms could not be relieved even by high-dose intravenous steroids. Two hours after the onset of the symptoms, intubation was required because of respiratory obstruction. Only after three days did the edema resolve (12.172). The Federal Institute of Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte; BfArM) has already recorded just as many reports of angioedema (25) for moxifloxacin, which was only introduced in 1999 (cf. a-t 1999; no. 9: 91), as for ofloxacin and significantly more reports than for levofloxacin (15) or ciprofloxacin (9; BfArM: letter of 3rd Dec. 2002). Bayer Vital nevertheless sees no need to refer explicitly to the risk of angioedema in the patient information leaflet of AVALOX, as this "is to be regarded as a symptom of an anaphylactic reaction" and this has been listed as an adverse effect (Bayer Vital: letter of 17. Dec. 2002). We regard this as misinformation, which endangers patients.



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