Reactions 1505, p3 - 14 Jun 2014

Safety concerns with voriconazoleThe potential risks of liver toxicity, phototoxicity and

squamous cell carcinoma of the skin (SCCS) are knownsafety issues with voriconazole, which is used inpaediatric (aged ≥2 years) and adult patients to treatspecific worsening, potentially life-threatening fungalinfections.

To monitor for potential liver toxicity, aspartate (AST)and alanine (ALT) transaminase levels should beassessed before initiating voriconazole treatment,weekly during the first month of treatment andthereafter on a monthly basis. If AST or ALT levelsbecome markedly elevated during voriconazoletreatment, the drug should be discontinued unless thebenefits of continuing therapy outweigh the risks in thatindividual. Patients should also be advised to avoidsunlight exposure and, if in sunlight, should wearprotective clothing and use sunscreen with a high sunprotection factor to avoid the risk of phototoxicity andSCCS. If a phototoxic reaction occurs, the patient shouldbe referred to a dermatologist, with discontinuation ofvoriconazole treatment considered. If voriconazoletreatment is continued after a phototoxic reaction, thepatient’s skin should be checked regularly to detect andmanage pre-cancerous lesions as early as possible, withtreatment discontinued if any pre-cancerous lesions orSCCS are detected. Of note, individuals may developSCCS without a prior phototoxic reaction.

To increase awareness and improve monitoring andmanagement of these risks, the manufacturer isdistributing tools to physicians and patients, including ahealthcare professionals’ question and answerbrochure, healthcare professionals’ checklist and apatient alert card.MHRA. Voriconazole: reminder of risk of liver toxicity, phototoxicity, andsquamous cell carcinoma -- test liver function before and during treatment and tellpatients to avoid sunlight exposure. Drug Safety Update 7: A2, No. 10, 30 May2014. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON418519 803104572

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Reactions 14 Jun 2014 No. 15050114-9954/14/1505-0001/$14.95 Adis © 2014 Springer International Publishing AG. All rights reserved