PMID- 31620272
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220410
IS  - 2042-0986 (Print)
IS  - 2042-0994 (Electronic)
IS  - 2042-0986 (Linking)
VI  - 10
DP  - 2019
TI  - Safety evaluation of intravenous immunoglobulin in pediatric patients: a 
      retrospective, 1-year observational study.
PG  - 2042098619876736
LID - 10.1177/2042098619876736 [doi]
LID - 2042098619876736
AB  - BACKGROUND: Intravenous immunoglobulin (IVIG) is a pooled human plasma protein 
      that has shown efficacy in treating a variety of disorders. IVIG is generally 
      well tolerated and has a good safety profile. There are various IVIG products 
      available on the market, which results in differences in efficacy and safety 
      profile. The aim of this study was to assess the safety profile of IVIG use in 
      pediatric patients and its association with other predicted factors. METHODS: 
      Retrospective chart review study of all pediatric patients who received IVIG as 
      an inpatient at Hamad General Hospital in Qatar during 2014. The occurrence of 
      adverse drug reactions (ADR) was tested for any association with other predicted 
      factors, such as patient age, IVIG dose, brand, and adherence to infusion 
      protocol. RESULTS: A total of 345 IVIG prescriptions were received by pediatric 
      patients during the study period. Most common documented side effects were: fever 
      (5.8%), chills (2.6%), and headache (2%). Renal insufficiency was observed only 
      in six cases, with five of those in 'Risk' category according to RIFLE criteria. 
      A hypersensitivity reaction was documented in seven patients, despite being 
      premedicated with paracetamol and/or diphenhydramine and following the infusion 
      protocol. None of the predicted factors were found to be significantly associated 
      with ADR incidence except IVIG brand. CONCLUSIONS: IVIG generally has a good 
      safety profile in pediatric patients, with low risk of severe ADR. More studies 
      are needed to evaluate the correlation between ADR and IVIG formulation, taking 
      into account other factors that may affect results.
CI  - (c) The Author(s), 2019.
FAU - Elajez, Reem
AU  - Elajez R
AUID- ORCID: 0000-0001-7824-3203
AD  - Hamad Medical Corp, P.O Box 3050, Doha, Qatar.
FAU - Ezzeldin, Asmaa
AU  - Ezzeldin A
AD  - Hamad Medical Corp, Doha, Qatar.
FAU - Gaber, Hossamaldein
AU  - Gaber H
AD  - Hamad Medical Corp, Doha, Qatar.
LA  - eng
PT  - Journal Article
DEP - 20191003
PL  - England
TA  - Ther Adv Drug Saf
JT  - Therapeutic advances in drug safety
JID - 101549074
PMC - PMC6777049
OTO - NOTNLM
OT  - Adverse drug reaction
OT  - Immunoglobulin
OT  - Pediatrics
COIS- Conflict of interest statement: The authors declare that there is no conflict of 
      interest.
EDAT- 2019/10/18 06:00
MHDA- 2019/10/18 06:01
PMCR- 2019/10/03
CRDT- 2019/10/18 06:00
PHST- 2018/12/16 00:00 [received]
PHST- 2019/08/26 00:00 [accepted]
PHST- 2019/10/18 06:00 [entrez]
PHST- 2019/10/18 06:00 [pubmed]
PHST- 2019/10/18 06:01 [medline]
PHST- 2019/10/03 00:00 [pmc-release]
AID - 10.1177_2042098619876736 [pii]
AID - 10.1177/2042098619876736 [doi]
PST - epublish
SO  - Ther Adv Drug Saf. 2019 Oct 3;10:2042098619876736. doi: 10.1177/2042098619876736. 
      eCollection 2019.