PMID- 19491552
OWN - NLM
STAT- MEDLINE
DCOM- 20090623
LR  - 20220318
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 121
IP  - 3
DP  - 2009 May
TI  - Original research: Intravenous ribavirin--review of the FDA's Emergency 
      Investigational New Drug Database (1997-2008) and literature review.
PG  - 139-46
LID - 10.3810/pgm.2009.05.2014 [doi]
AB  - Intravenous (IV) ribavirin does not have US Food and Drug Administration (FDA) 
      approval, although oral and aerosol formulations have been approved. Intravenous 
      ribavirin can, however, be authorized for use as a result of an Emergency 
      Investigational New Drug (EIND) application as investigational treatment for 
      patients with serious viral infections, including emerging or rare infections for 
      which no alternative treatment is available. This retrospective study evaluated 
      clinical experience with IV ribavirin based on a review of the FDA's EIND 
      database and a literature review. The main outcome measures were disease 
      condition, clinical outcomes, and adverse events (AEs). First, the FDA's EIND 
      database was evaluated for these variables among patients authorized to receive 
      investigational IV ribavirin. Second, published literature on IV ribavirin was 
      reviewed for diseases treated, reported clinical outcomes, and AEs. Adverse 
      events reported in the literature were compared with AEs listed in approved 
      product labeling (aerosol and oral formulations). From February 1997 to December 
      2008, 608 IV ribavirin EIND requests were made for 19 disease conditions. 
      Adenovirus, respiratory syncytial virus, and parainfluenza infections comprised 
      84.7% of IV ribavirin EINDs. Inadequate reporting of clinical outcomes and AEs in 
      the EIND database prevented analysis of either outcome. Data interpretation in 
      the literature was limited by multiple factors, including retrospective design, 
      small sample sizes, differences in reporting outcomes and AEs, lack of 
      generalizability, and potential confounders such as concomitant medications, 
      selection bias, and reporting bias. Reported AEs were consistent with labels of 
      approved aerosol and oral formulations, except for lip and gingival swelling. 
      However, estimates of frequency, severity, and causality of AEs associated with 
      IV ribavirin could not be determined because of study limitations. Our study 
      findings suggest that the literature is inconclusive on the potential benefit for 
      continued use of IV ribavirin. A review of the literature and the FDA's EIND 
      database suggests that prospective, controlled trials of IV ribavirin in patients 
      with adenovirus, parainfluenza, or serious respiratory syncytial virus infections 
      could be feasible.
FAU - Riner, Andrea
AU  - Riner A
AD  - OND/DAVP, Center for Drug Evaluation and Research, U.S. Food and Drug 
      Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
FAU - Chan-Tack, Kirk M
AU  - Chan-Tack KM
FAU - Murray, Jeffrey S
AU  - Murray JS
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (Antiviral Agents)
RN  - 0 (Drugs, Investigational)
RN  - 49717AWG6K (Ribavirin)
SB  - IM
MH  - Antiviral Agents/*administration & dosage
MH  - Drug Approval/*methods
MH  - Drugs, Investigational/*administration & dosage
MH  - Humans
MH  - Injections, Intravenous
MH  - Ribavirin/*administration & dosage
MH  - Treatment Outcome
MH  - United States
MH  - *United States Food and Drug Administration
MH  - Virus Diseases/*drug therapy
RF  - 66
EDAT- 2009/06/06 09:00
MHDA- 2009/06/24 09:00
CRDT- 2009/06/04 09:00
PHST- 2009/06/04 09:00 [entrez]
PHST- 2009/06/06 09:00 [pubmed]
PHST- 2009/06/24 09:00 [medline]
AID - 10.3810/pgm.2009.05.2014 [doi]
PST - ppublish
SO  - Postgrad Med. 2009 May;121(3):139-46. doi: 10.3810/pgm.2009.05.2014.