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New In Coagulation
Thursday, July 10, 2008
Information on Adverse Event Reports and Heparin
Date created: April 8, 2008, updated June 16, 2008
http://www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm
The chart below shows numbers of deaths reported after heparin administration that occurred and were submitted to FDA from January 1, 2007 through May 31, 2008.
- The reports are sorted according to the date of the medical event in the report, indicated in the first column. This date may be different than the date of death.
- The second column indicates the number of deaths reported after heparin administration, regardless of cause.
- The third column indicates the number of death reports that included one or more allergic symptom(s) or symptoms of hypotension (low blood pressure). These are the events that prompted a series of heparin recalls.
- There have been 246 reports of death reported to FDA since January 1, 2007; 238 were reported to FDA on or after January 1, 2008.
- Of the 149 reports that included one or more allergic symptom(s) or symptoms of hypotension and death, 146 were reported to FDA on or after January 1, 2008.
- The fact that allergic symptoms or hypotension was reported does not mean that these were the cause of death in all cases.
- FDA received reports of 97 patients who died without mention of allergy or hypotension. These patients died of a variety of causes.
- In the majority of reports with a death outcome, there was not enough clinical information to assess the relationship between death and the use of heparin.
- The recent internet posting from the Center for Devices and Radiological Health (CDRH) (http://www.fda.gov/cdrh/safety/heparin-qanda.html) states that CDRH has received reports of 11 deaths associated with heparin-containing devices. The CDRH reporting system is separate from the Adverse Event Reporting System (AERS) used to capture the reports counted below. It is possible that reports of one death were sent to both systems, and could potentially be counted twice.
Donna Castellone
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About the Author
Donna Castellone,
MS, MT(ASCP)SH
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