The Heparin Disaster: FDA links 149 deaths to contaminated Heparin
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The Heparin Disaster



Thursday, July 24, 2008  

FDA links 149 deaths to contaminated Heparin

The FDA recently increased the number of reported deaths in which one or more allergic / hypotensive symptoms occurred in correlation to the receipt of heparin to 149 deaths.

Here is the table from the FDA Report:

Number of Deaths of Patients Receiving Heparin Reported to FDA,
January 1, 2007 through May 31, 2008

Month the Medical Event(s) Occurred Number of Reported Deaths* Reported Deaths with One or More Allergic/Hypotensive Symptom(s)

Jan-07

6

3

Feb-07

2

1

Mar-07

5

2

Apr-07

7

4

May-07

3

1

Jun-07

5

2

Jul-07

6

3

Aug-07

4

4

Sep-07

3

2

Oct-07

10

5

Nov-07

12

11

Dec-07

34

23

Jan-08

50

32

Feb-08

49

29

Mar-08

14

10

Apr-08
7
4
May-08
5
3

Unknown date

24

10

Total

246

149

*The reports in this table concern heparin produced by any manufacturer.


A review of this table shows a significant spike in events for the months of November 2007 through March of 2008. There is no doubt but that this spike is the result of deaths caused by the contaminant oversulfated chondroitin sulfate (OSCS), which was intentionally added to the raw heparin in China.

While there have been a few deaths related to products sold by other manufacturers, the overwhelming majority of the deaths arose from the administration of heparin manufactured and sold by Baxter.

There is also no question but that this table significantly underestimates the actual number of people who died from the contaminated heparin. The FDA adverse events reports only capture a relatively small percentage of the actual number of adverse events.

According to the FDA: "A small percentage of adverse reactions are reported to Centers for Deisease Control and Prevetnion and FDA by health care professionals and industry."

Therefore the actual number of deaths attibutable to the contaminated heparin is much larger.

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