arznei-telegramm 2013; 44: 32


Bradycardia on febuxostat (ADENURIC): An 83-year-old man was taking febuxostat (ADENURIC) to treat hyperuricaemia, owing to renal impairment only half an 80 mg tablet daily*. Three weeks after the start of treatment he reported dizziness, nausea and a pulse slowed to 35 beats per minute. After discontinuation of the xanthine oxidase inhibitor, he had bradycardia (< 40 b.p.m) for another five days before his heart rate returned to normal. As well as other previous illnesses, he suffers from coronary heart disease. For some time he has been taking bisoprolol (e.g. BISOPROLOL AL), urapidil (e.g. EBRANTIL) and amlodipine (e.g. AMLODIPIN AL) which can also trigger bradycardia (NETZWERK Report 16.240). On febuxostat cardiac disturbances such as atrial fibrillation, palpitations and ECG changes are uncommon (0.1% to < 1%). Bradycardia is not mentioned in the German Summary of Product Characteristics (SPC; Berlin-Chemie, Menarini: ADENURIC SPC, dated December 2012), while the US prescribing information lists sinus bradycardia as an undesirable effect (< 1%; Takeda [USA]: ULORIC prescribing information, dated November 2012). The Federal Institute for Drugs and Medical Devices (BfArM) internationally overviews two suspected reports of bradycardia on febuxostat (BfArM: letter dated 25 January 2013). If ischaemic heart disease is present, as described above, administration is advised against according to the SPC because there is a suspicion of increased cardiovascular events on febuxostat. In any case, we regard the xanthine oxidase inhibitor as a strict reserve drug when either allopurinol (ZYLORIC, generics) as the drug of choice or uricosuric agents such as benzbromarone (BENZBROMARON AL) are out of the question (see a t 2010; 41: 25-7).



Halving of the tablets and a dose reduction in renal impairment are not provided for in the SPC.

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