The Spider Web of Heparin Clues

Posted on 10th April 2008 by gjohnson in Uncategorized

Baxter Heparin Wrongful Death case Illinois, CDC investigation heparin, FDA recall of Heparin, heparin, heparin adverse reactions

When the FDA announced the recall of Baxter’s Heparin in January, it was limited to nine lots. The FDA’s recent statements make it clear this contamination is much broader. The number of suspected deaths has risen to 62. Below are portions of the FDA’s release on Heparin on April 8, 2008:

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.

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

Click here to see this chart.

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.

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.

62 deaths. That is a lot, yet probably only a portion of the problem. The FDA implies that the number is higher than is truly related, because of the serious conditions that could have caused the reported problems. But for the same reason, we believe that the amount is severely under-reported. Because this group of people was otherwise ill, the typical doctor may have had no reason to suspect that what appeared to be a normal consequence of the illness, is in fact an allergic reaction. We believe that is entirely possible that the reason the number of reported deaths and reactions went up so dramatically after the first warning was flagged late in 2007, was that someone actually started to look for the pattern.