PMID- 20661880
OWN - NLM
STAT- MEDLINE
DCOM- 20101213
LR  - 20100902
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 19
IP  - 9
DP  - 2010 Sep
TI  - Description of hypersensitivity adverse events following administration of 
      heparin that was potentially contaminated with oversulfated chondroitin sulfate 
      in early 2008.
PG  - 921-33
LID - 10.1002/pds.1991 [doi]
AB  - PURPOSE: To characterize the nature of a heparin contaminant's clinical effects 
      in cases reported to the Adverse Event Reporting System (AERS). The FDA received 
      reports of heparin-associated adverse events (AEs) starting in late 2007-early 
      2008 during a national investigation of allergic-type events. The investigation 
      identified Baxter Healthcare-brand heparin product due to its strongest 
      association with the events. Later, oversulfated chondroitin sulfate (OSCS), a 
      heparin-like contaminant, was discovered. METHODS: This study was a case series 
      of heparin reports in AERS received 1 January 2008 to 31 March 2008. Variables 
      considered were frequency of treatment settings, AEs, mortality; as well as 
      heparin dose and OSCS contamination. RESULTS: Five hundred seventy-four AERS 
      cases (unduplicated reports) were identified and included. Of 94 cases with a 
      fatal outcome, 68 reported at least one AE term from the list used to identify an 
      allergic-type event. Nearly 75% of AEs in cases of IV administration (n = 
      170/233) reportedly occurred within 10 minutes, whereas over half of subcutaneous 
      administration cases (n = 13/23) resulted in times-to-event of greater than 24 
      hours. Although cases with a time-to-event of less than 10 minutes appeared to 
      correlate with higher levels of OSCS contamination, no clear differences were 
      noted between high- and low-to-absent OSCS concentration lots with respect to AEs 
      observed. CONCLUSIONS: Intravenous administration and a higher OSCS concentration 
      appeared to correlate with a more rapid onset of event. The FDA continues to 
      monitor AEs associated with heparin use and has taken appropriate regulatory 
      action to ensure a safe heparin drug supply.
CI  - (c) 2010 by John Wiley & Sons, Ltd.
FAU - McMahon, Ann W
AU  - McMahon AW
AD  - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, 
      Food and Drug Administration, Silver Spring, MD 20993, USA. 
      ann.mcmahon@fda.hhs.gov
FAU - Pratt, Robert G
AU  - Pratt RG
FAU - Hammad, Tarek A
AU  - Hammad TA
FAU - Kozlowski, Steven
AU  - Kozlowski S
FAU - Zhou, Esther
AU  - Zhou E
FAU - Lu, Susan
AU  - Lu S
FAU - Kulick, Corrinne G
AU  - Kulick CG
FAU - Mallick, Tarun
AU  - Mallick T
FAU - Dal Pan, Gerald
AU  - Dal Pan G
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Anticoagulants)
RN  - 9005-49-6 (Heparin)
RN  - 9007-28-7 (Chondroitin Sulfates)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/*adverse effects/chemistry/standards
MH  - Child
MH  - Child, Preschool
MH  - Chondroitin Sulfates/*adverse effects/chemistry/standards
MH  - Drug Contamination
MH  - Drug Hypersensitivity/*etiology
MH  - Female
MH  - Heparin/*adverse effects/chemistry
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Time Factors
MH  - United States
MH  - United States Food and Drug Administration
MH  - Young Adult
EDAT- 2010/07/28 06:00
MHDA- 2010/12/14 06:00
CRDT- 2010/07/28 06:00
PHST- 2010/07/28 06:00 [entrez]
PHST- 2010/07/28 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
AID - 10.1002/pds.1991 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2010 Sep;19(9):921-33. doi: 10.1002/pds.1991.