Document Detail


Tenofovir-associated Fanconi syndrome: review of the FDA adverse event reporting system.
MedLine Citation:
PMID:  18260800     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Tenofovir disoproxil fumarate (TDF) is a commonly used HIV antiretroviral. A relatively uncommon adverse effect of this drug is Fanconi syndrome. What is known about this toxicity, especially in regards to concomitant medication use and outcomes, is limited to isolated case reports and small case series. Therefore, a retrospective review of the FDA Adverse Event Reporting System from 2001 through 2006 was conducted to examine demographics, concomitant medication use, outcomes, and temporal trends in reporting of Fanconi syndrome associated with TDF use. In this large case series of 164 subjects who met the case definition for Fanconi syndrome, the majority (83%) of the subjects received protease inhibitors (PI) with TDF; specifically, 74% of the total received a ritonavir-boosted PI. Didanosine was the most commonly (43%) prescribed nucleoside reverse transcriptase inhibitor (NRTI). The combination of didanosine with boosted PI was frequently observed (34%), and in particular, didanosine plus lopinavir/ritonavir was documented for 22%. Nearly half (46%) of the total were hospitalized. Fracture (2%) and requirement for dialysis (2%) were infrequent while Fanconi syndrome contributed to death in 2% of these subjects. Patients receiving ritonavir-boosted protease inhibitors or didanosine with tenofovir should be closely monitored for development of nephrotoxicity. Although reporting biases and the exclusion of reports with serious confounding conditions likely affected the estimation of outcomes in this case series, severe complications of tenofovir-associated Fanconi syndrome were uncommon.
Authors:
Samir K Gupta
Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  AIDS patient care and STDs     Volume:  22     ISSN:  1557-7449     ISO Abbreviation:  AIDS Patient Care STDS     Publication Date:  2008 Feb 
Date Detail:
Created Date:  2008-02-11     Completed Date:  2008-04-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9607225     Medline TA:  AIDS Patient Care STDS     Country:  United States    
Other Details:
Languages:  eng     Pagination:  99-103     Citation Subset:  IM; X    
Affiliation:
Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, Indiana, USA. sgupta1@iupui.edu
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MeSH Terms
Descriptor/Qualifier:
Adenine / adverse effects,  analogs & derivatives*,  therapeutic use
Adolescent
Adult
Adverse Drug Reaction Reporting Systems*
Aged
Anti-HIV Agents / adverse effects*,  therapeutic use
Child
Fanconi Syndrome / chemically induced*,  epidemiology*
Female
HIV Infections / diagnosis,  drug therapy*
Humans
Incidence
Male
Middle Aged
Phosphonic Acids / adverse effects*,  therapeutic use
Registries
Retrospective Studies
Risk Assessment
Survival Analysis
United States / epidemiology
United States Food and Drug Administration
Grant Support
ID/Acronym/Agency:
K23 HL073682/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Phosphonic Acids; 107021-12-5/tenofovir; 73-24-5/Adenine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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