Reactions 1447 - 13 Apr 2013

Relpax contraindicationsunderscored after CV events

In Italy, Pfizer is allerting healthcare professionals toseveral cases of adverse cardiovascular events that havefollowed the use eletriptan [Relpax] in patients with pre-existing conditions, and/or using medications, that arecontraindicated.

The company, in agreement with the ItalianMedicines Agency (AIFA), is drawing attention to theantimigraine drug’s contraindications, which include ahistory of hypersensitivity to the drug, various pre-existing cardiovascular disorders, severe hepatic or renalimpairment, concomitant administration of anergotamine or ergotamine-derivative, and concomitantadministration of a serotonin receptor agonist.

Between February 2008 and December 2012,15 confirmed cases of cerebrovascular events had beenreported worldwide following use of eletriptan. Ofthese, 14 (93%) were considered severe. Four casesreported history of a condition, and/or use of amedicine, that was contraindicated. Over the same timeperiod, there were 85 confirmed cases of cardiovascularevents; 55 (65%) were considered severe, and17 reported having occurred in patients with acondition, or using a medication, that wascontraindicated.Pfizer, et al. RELPAX (Eletriptan bromidrato): Controindicazioni nellasomministrazione di Relpax. Internet Document : 1 Apr 2013. Available from:URL: http://www.agenziafarmaco.gov.it 803085708

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Reactions 13 Apr 2013 No. 14470114-9954/10/1447-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved