The Food and Drug Administration yesterday raised from 19 to 62 its estimate of the number of people who may have died after suffering allergic reactions or hypotension to contaminated Chinese-produced batches of the blood thinner heparin.
Last month the FDA determined that Baxter Healthcare Corporation’s drug was contaminated with an unnatural chemical during production at a plant in China. The agency is still investigating whether the chemical was added accidentally or deliberately. Further information may ultimately be uncovered during any product liability lawsuits that may be brought.
Also last month, the FDA announced that Baxter had extended its recall of multi-dose vials of heparin sodium for injection to also include single-dose vials of heparin sodium for injection. As a precautionary measure Baxter also recalled its heparin lock flush products. The heparin source manufacturer for lock flush solutions is the same as that for Baxters heparin sodium for injection.
The following is excerpted from the FDA’s “Information on Adverse Event Reports and Heparin”, dated April 8, 2008: 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.
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