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Current advances in pharmacovigilance in the USA and Europe: meeting the challenges of safety monitoring in HIV

Marcus, Kendall A.a; Sorbello, Alfredb; Truffa, Melissab; Williams, Juliec; Raine, June M.c; Powderly, William G.d

Current Opinion in HIV and AIDS: July 2012 - Volume 7 - Issue 4 - p 292–298
doi: 10.1097/COH.0b013e328354dcac

Purpose of review The success of antiretroviral therapy in HIV disease comes currently with the realization that patients are committed to life-long treatment, which raises the possibility of long-term toxicity. Such long-term side effects may not be identified in initial clinical trials requiring, therefore, a different approach to monitoring patients over time – a pharmacovigilance approach.

Recent findings Several key issues in long-term management of HIV infection have been addressed by a pharmacovigilance approach – including unusual and rare side effects and elucidation of emerging toxicities such as cardiovascular, bone and renal disease. Recent changes in legislation in the USA and Europe are aimed to strengthen pharmacovigilance in developed countries.

Summary HIV infection and its treatment provide an important example of the role of pharmacovigilance. As clinical trials can rarely address the question of long-term tolerability, effective pharmacovigilance programs are and will remain essential.

aOffice of New Drugs

bOffice of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland USA

cMedicines and Healthcare Products Regulatory Agency, London UK

dSchool of Medicine and Medical Sciences, University College Dublin, Belfield, Dublin, Ireland

Correspondence to Professor William G. Powderly, UCD School of Medicine and Medical Sciences, Health Sciences Centre, University College Dublin, Belfield, Dublin 4, Ireland. Tel: +353 1 7166609; fax: +353 1 7166585; e-mail:

© 2012 Lippincott Williams & Wilkins, Inc.