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.
    
    
    

• 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.

• FDA continues to receive reports of adverse events occurring after heparin administration.
• FDA will analyze these and all other reports of adverse events after heparin administration.
• FDA will update the data on this website on a periodic basis.

• Patients, consumers, physicians, nurses, pharmacists, and others can report adverse events either directly to the FDA via the MedWatch program (http://www.fda.gov/medwatch/), or to the drug product’s manufacturer.
• FDA receives approximately 400,000 reports of adverse events per year.
• The majority of these (over 90%) come from manufacturers.

• The public can send reports of adverse events to FDA or the manufacturer any time after the event occurs.
• In some cases, the report is sent to FDA or the manufacturer several months or more after the event has occurred.
• After there is a lot of media attention to a particular adverse event, often more reports of similar adverse events are submitted.
• The fact that someone reports an adverse event does not necessarily mean that a specific drug caused the medical event or death.
• Reports have to be analyzed to see if there is a plausible causal association between the drug and the medical event.
• It is often not possible to tell in an individual case if there is a causal relationship between the drug and the medical event or death. 
• Many patients have other serious conditions that could have caused the reported problem.

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Date created: April 8, 2008, updated April 21, 2008

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