PMID- 14571392
OWN - NLM
STAT- MEDLINE
DCOM- 20040708
LR  - 20220311
IS  - 0887-7963 (Print)
IS  - 0887-7963 (Linking)
VI  - 17
IP  - 4
DP  - 2003 Oct
TI  - Risks associated with the use of intravenous immunoglobulin.
PG  - 241-51
AB  - Although US immune globulin intravenous (human) (IGIV) products have been 
      regarded as safe, it is important to recognize that many of the controlled 
      clinical studies of IGIVs have been of modest size and have limited power to 
      define the incidence of only the most common adverse events (AEs). A significant 
      number of "postmarketing" serious AEs affecting renal, cardiovascular, CNS, 
      integumentary, and hematologic organ systems have been reported. Variables 
      potentially affecting the risk and intensity of adverse events associated with 
      administration of IGIV include patient age, underlying condition, history of 
      migraine, cardiovascular or renal disease, dose, concentration, rate of infusion, 
      specific brand/formulation/excipients, and lot(s) of the particular IGIV product 
      being administered. Each manufacturer's IGIV preparation is a unique product 
      carrying its own specific evidence-based indications and safety profile. In view 
      of the seriousness of potential adverse effects of IGIV products, and current 
      lack of data surrounding their frequency, clinicians are advised to limit their 
      prescription of these products for conditions for which efficacy is supported by 
      adequate and well-controlled clinical trials. Prescribers should pay close 
      attention to patient selection; consider the potential risk/benefit ratio 
      vis-a-vis alternate therapies; and familiarize themselves with the 
      identification, management, and proposed strategies to minimize the risks of 
      IGIV.
FAU - Pierce, L Ross
AU  - Pierce LR
AD  - Clinical Review Branch, Division of Hematology, Center for Biologics Evaluation 
      and Research, Food and Drug Administration, Rockville, MD 20852-1448, USA.
FAU - Jain, Nisha
AU  - Jain N
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Transfus Med Rev
JT  - Transfusion medicine reviews
JID - 8709027
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Humans
MH  - Immunoglobulins, Intravenous/*adverse effects
MH  - Practice Guidelines as Topic
MH  - Product Surveillance, Postmarketing
MH  - Risk
RF  - 54
EDAT- 2003/10/23 05:00
MHDA- 2004/07/09 05:00
CRDT- 2003/10/23 05:00
PHST- 2003/10/23 05:00 [pubmed]
PHST- 2004/07/09 05:00 [medline]
PHST- 2003/10/23 05:00 [entrez]
AID - S0887796303000385 [pii]
AID - 10.1016/s0887-7963(03)00038-5 [doi]
PST - ppublish
SO  - Transfus Med Rev. 2003 Oct;17(4):241-51. doi: 10.1016/s0887-7963(03)00038-5.