Deaths and Injuries Linked to Heparin
Posted by
Greg OwenMarch 19, 2008 1:36 PMThe Food and Drug Administration (FDA) is working to identify the contaminant that has been found in Heparin, which may be linked to as many as 19 deaths. Although, at this time, the FDA has not established a direct causal link. The drug Heparin is used in dialysis and heart procedures to stave off blood clots. Baxter sells somewhere in the range of 35 million units of heparin sodium injection multi and single dose vials per year in the U.S. alone. Those sales amount to approximately $30 million annually.
Initially, there were nine lot of heparin recalled by Baxter Healthcare corporation. The January 17, 2008, recall was initiated due to reports of a sudden increase in adverse effects from consumers of the product. A host of health problems were reported including, vomiting, abdominal pain and decreased blood pressure.
Baxter released a recall update on February 11, 2008. The company announced that the recall would be expanded due to the fact that they had received reports that consumers were experiencing adverse effects from additional heparin products. It was at that time that Baxter decided to suspend further production of heparin. Although, the vials of heparin that were on the market remained on the market due to a concern pertaining to a diminished supply of heparin to consumers. Baxter also noted, at that time, that adverse effects from the drug could actually be life-threatening.
Shortly after the February 11, 2008 expanded recall, it was reported by The Wall Street Journal that the active ingredient in heparin came from none other than China. At this time, the FDA is inspecting the Chinese facility, but have yet to make an announcement as to their findings. As recently as February 28, 2008, it was announced by Baxter that it would recall all sizes and lots of heparin. By the last week in February the only heparin product that was still on the market was the Haparin IV bags. On the heels of the expanded recall in late February, it was reported by the FDA during the first week of March that a molecule very similar to heparin had been found in the heparin ingredients sent to Baxter by Scientific Protein Laboratories (SPL).
The FDA has reported that up to 21 deaths and 448 allergic reactions may be linked to Heparin. The reports continue to come in and the exact numbers of people adversely effected by this drug are currently unknown, but the numbers continue to grow. Stay tuned for further updates.
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