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


RESULTS
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.


CONCLUSIONS
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.
Office of New Drugs, Food and Drug Administration, Silver Spring, Maryland, USA.
Kendall A
KA
Marcus
Alfred
A
Sorbello
Melissa
M
Truffa
Julie
J
Williams
June M
JM
Raine
William G
WG
Powderly
D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005060:Europe / Q000453:epidemiology; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D060735:Pharmacovigilance; D014481:United States / Q000453:epidemiology
D019380:Anti-HIV Agents