Alcohol addiction - the safety of available approved treatment options.

Mariangela Antonelli, Anna Ferrulli, Luisa Sestito, Gabriele A Vassallo, Claudia Tarli, Carolina Mosoni, Maria M Rando, Antonio Mirijello, Antonio Gasbarrini, Giovanni Addolorato

Journal: Expert opinion on drug safety 2018;17(2):169-177

PMID: 29120249

Abstract

INTRODUCTION

Alcohol Use Disorders (AUD) is a leading cause of mortality and morbidity worldwide. At present disulfiram, naltrexone and acamprosate are approved for the treatment of AUD in U.S. and Europe. Nalmefene is approved in Europe and sodium oxybate is approved in Italy and Austria only. Baclofen received a 'temporary recommendation for use' in France.

AREAS COVERED

The safety of the above mentioned medications on liver, digestive system, kidney function, nervous system, pregnancy and lactation and their possible side effects are described and discussed.

EXPERT OPINION

Mechanism of action and metabolism of these drugs as well as patients' clinical characteristics can affect the safety of treatment. All approved medications are valid tools for the treatment of AUD in patients without advanced liver disease. For some drugs, attention should be paid to patients with renal failure and medications may be used with caution, adjusting the dosage according to kidney function. In patients with AUD and advanced liver disease, at present only baclofen has been formally tested in randomized controlled trials showing its safety in this population.

Address: a Alcohol Use Disorders Unit , Università Cattolica del Sacro Cuore , Rome , Italy.; b Department of Endocrinology and Metabolic Disease , IRCCS Policlinico San Donato , Milan , Italy.; c Department of Medical Sciences , IRCCS Casa Sollievo della Sofferenza Hospital , San Giovanni Rotondo , Italy.; d Department of Internal Medicine, Gastroenterology and Hepatology , Università Cattolica del Sacro Cuore , Rome , Italy.

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