Information on Adverse Event Reports and Heparin

• The chart below shows numbers of deaths reported after heparin administration that occurred and were submitted to FDA from January 1, 2007 through April 13, 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 131 reports of death reported to FDA since January 1, 2007; 123 were reported to FDA on or after January 1, 2008.
  • - Of the 81 reports that included one or more allergic symptom(s) or symptoms of hypotension and death, 78 were reported to FDA on or after January 1, 2008.
  • - The fact that allergic symptoms or hypotension were reported does not mean that these were the cause of death in all cases.
  • - FDA received reports of 50 patients who died without mention of allergy or hypotension. These patients died of a variety of causes.
    
    
    

Number of Deaths of Patients Receiving Heparin Reported to FDA, January 1, 2007 through April 13, 2008
Month the Medical Event(s) Occurred	Number of Reported Deaths*	Reported Deaths with One or More Allergic/Hypotensive Symptom(s)
Jan-07	3	1
Feb-07	1	0
Mar-07	4	2
Apr-07	4	2
May-07	2	1
Jun-07	3	2
Jul-07	4	2
Aug-07	1	1
Sep-07	2	2
Oct-07	7	4
Nov-07	11	10
Dec-07	20	13
Jan-08	31	21
Feb-08	28	18
Mar-08	3	0
Unknown date	7	2
Total	131	81
*The reports in this table concern heparin produced by any manufacturer.

 

• For comparison purposes, FDA reviewed the reports it received for all deaths of patients in whom heparin was listed as a potentially suspect drug in 2006.
  • - A total of 55 deaths were reported from January 1, 2006 to December 31, 2006 - an average of four or five per month.
  • - Across these 55 reports of death, there were a variety of underlying medical conditions.
  • - Three of the reports listed allergic reactions or hypotension (low blood pressure) as a medical event, similar events to the cases that prompted the heparin recall in 2008.

 

Number of Deaths of Patients Receiving Heparin Reported to FDA, January 1, 2006 through December 31, 2006
Year the Medical Event(s) Occurred	Number of  Reported Deaths*	Reports with One or More Allergic/Hypotensive Symptom(s)
2006	55	3
* The reports in this table concern heparin produced by any manufacturer.