Government
FDA lists deaths linked to heparin
By FDA
Apr 9, 2008 - 8:19:09 AM

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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 over the last fifteen months (i.e., from January 1, 2007 through March 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 103 reports of death since January 1, 2007; 91 were reported to FDA on or after January 1, 2008.
• Of the 62 reports of death that included one or more allergic symptom(s) or symptoms of hypotension, 56 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 41 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, more reports of similar adverse events are often 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.