Reactions 1510, p3 - 19 Jul 2014

Telavancin: important safetyconcerns

Information on safety concerns (nephrotoxicity, QTinterval prolongation, and a potential for teratogeniceffects) associated with the use of telavacin (Vibativ),and recommendations for reducing the risks, have beenprovided by Clinigen as a condition of marketingauthorisation set by the EMA, and reported by the UKMHRA.

Telavancin has been approved in the EU for thetreatment of MRSA*-associated nosocomial pneumoniawhen other drugs are not appropriate or have failed, andshould not be used for non-approved indications.Telavancin has been reported to increase the risk ofdeath in patients with acute renal failure, and istherefore contraindicated in patients with CrCl<30 mL/min. It should be used with caution in patientsat high risk of QTc prolongation or receiving other drugswhich prolong the QTc interval. It is contraindicatedduring pregnancy because of potential fetal toxicity.Suspected adverse reactions should be reported toClinigen† or to the MHRA.††

* methicillin-resistant Staphylococcus aureus† pharmacovigilance@Aptivsolutions.com†† www.mhra.gov.uk/yellowcard

MHRA. Direct Healthcare Professional Communication on the launch of Vibativ(telavancin): recommendations for use and important risks (nephrotoxicity, QTcprolongation, reproductive toxicity and off-label use). Internet Document : 16 Jun2014. Available from: URL: http://www.mhra.gov.uk/home/groups/comms-ic/documents/drugsafetymessage/con428392.pdf 803105896

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Reactions 19 Jul 2014 No. 15100114-9954/14/1510-0001/$14.95 Adis © 2014 Springer International Publishing AG. All rights reserved