PMID- 21755809
OWN - NLM
STAT- MEDLINE
DCOM- 20110819
LR  - 20181201
IS  - 0004-4172 (Print)
IS  - 0004-4172 (Linking)
VI  - 61
IP  - 5
DP  - 2011
TI  - Differences in spontaneously reported hypersensitivity and serious adverse events 
      for intravenous iron preparations: comparison of Europe and North America.
PG  - 267-75
LID - 10.1055/s-0031-1296198 [doi]
AB  - Spontaneously-reported rates of adverse events (AEs) of intravenous (i.v.) iron 
      products have not been compared since 2007. AEs in Europe (Eur) and North America 
      (NA) have never been compared. New products have been marketed and many changes 
      in prescribing habits have occurred since then, and the effect on AEs reporting 
      is unclear. It was hypothesized that changing practices for i.v. iron products 
      has caused changes in the rates of serious AEs and large differences exist 
      between Eur and NA. Rates of AEs for three i.v. iron preparations (iron sucrose 
      [IS], ferric gluconate [FG] and high and low MW iron dextran [HMWID, LMWID]) were 
      compared by product and continent from January 1, 2003 to June 30, 2009 for 
      selected countries in Eur and NA, using the Uppsala Monitoring Center's database. 
      Rates of total, anaphylaxis and other serious allergic AEs were calculated as 
      number of AEs divided by i.v. iron sales standardized to 100 mg dose equivalents 
      (DEq) of iron. Quarterly sales (millions of 100 mg DEq of iron) increased from 
      the first quarter 2003 to the end of the second quarter of 2009 by 1% for FG, 16% 
      for IS and 2% for ID. Total AEs for NA plus Eur were similar for FG and IS, but 
      total AEs were 6- to 7-fold higher for ID. Rates of anaphylaxis were 6- to 
      11-fold higher in Eur plus NA combined for ID than for IS or FG. In NA, there 
      were substantially higher reports for total, anaphylaxis and other serious 
      allergic AEs with FG compared to IS, whereas the reverse was the case in Eur. 
      Odds ratios (OR) showed higher risks of anaphylaxis with FG in NA vs. Eur (OR = 
      4.40, P < 0.0001) and lower risks with IS (OR = 0.24, P < 0.0001). Odds of 
      anaphylaxis with LMWID in Eur vs. FG and IS were 42.08 and 16.92 (both P < 
      0.0001), respectively. In NA, odds of anaphylaxis with ID vs. FG and IS were 2.36 
      and 17.73 (both P < 0.0001), respectively. Differences between NA and Eur may be 
      related to varied treatment practices. ID had the highest rates of all types of 
      AEs, and IS and FG had a continued trend for lowest rates of AEs.
FAU - Bailie, George R
AU  - Bailie GR
AD  - Albany Nephrology Pharmacy Group, Albany College of Pharmacy and Health Sciences, 
      Albany, NY 12208, USA. george.bailie@acphs.edu
FAU - Horl, Walter H
AU  - Horl WH
FAU - Verhoef, Jan-Jaap
AU  - Verhoef JJ
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Arzneimittelforschung
JT  - Arzneimittel-Forschung
JID - 0372660
RN  - 0 (Ferric Compounds)
RN  - 0 (Iron Compounds)
RN  - 9004-66-4 (Iron-Dextran Complex)
RN  - FZ7NYF5N8L (Ferric Oxide, Saccharated)
RN  - QLZ991V4A2 (Glucaric Acid)
RN  - W108RK810P (ferric gluconate)
SB  - IM
MH  - Anaphylaxis/epidemiology
MH  - Drug Hypersensitivity/*epidemiology
MH  - Europe/epidemiology
MH  - Ferric Compounds/adverse effects
MH  - Ferric Oxide, Saccharated
MH  - Glucaric Acid
MH  - Humans
MH  - Injections, Intravenous
MH  - Iron Compounds/administration & dosage/*adverse effects
MH  - Iron-Dextran Complex/adverse effects
MH  - North America/epidemiology
MH  - Odds Ratio
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
EDAT- 2011/07/16 06:00
MHDA- 2011/08/20 06:00
CRDT- 2011/07/16 06:00
PHST- 2011/07/16 06:00 [entrez]
PHST- 2011/07/16 06:00 [pubmed]
PHST- 2011/08/20 06:00 [medline]
AID - 10.1055/s-0031-1296198 [doi]
PST - ppublish
SO  - Arzneimittelforschung. 2011;61(5):267-75. doi: 10.1055/s-0031-1296198.