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David Mittleman
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FDA Announces Heparin Recall

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Late last month the Food and Drug Administration (FDA) announced that the drug manufacturer Baxter International would be recalling all of its remaining Heparin products. Earlier in February, the FDA issued a Public Health Advisory warning doctors and other health care providers not to use Baxter Heparin products. According to the FDA, there have been hundreds of reports of serious side effects linked to Baxter Heparin already in 2008. As many as 24 people may have died as a result of exposure to Baxter Heparin; most of the reported reactions have been in dialysis patients who receive high doses over a short time period.

Heparin is an anticoagulant (blood thinner), often important in surgical procedures and used to prevent blood clots in patients. Baxter manufactures about half of the multi-dose vials of Heparin used in the United States. A variety of symptoms have been reported: abdominal pain, headaches, diarrhea, dizziness, blood pressure changes, nausea, vomitting, swelling, rapid heart rate, paresthesia (tingling or numbness), and restlessness.

I belive at this time that the Heparin involved in these reactions was defective, and that the drug company failed to properly regulate the drug’s production. Overseas suppliers may have contributed to the defects: A Chinese factory that supplied the active ingredient for the Baxter Heparin had never been inspected by the FDA. Wisconsin-based Scientific Protein Laboratories, LLC owns the plant. When the FDA finally did conduct an inspection of the Chinese Heparin supplier, many serious violations were identified. Contaminants were found in the active ingredient, as well as chemical differences in the active ingredient used in the lots of Heparin associated with the adverse drug reactions.

The serious reactions have generally been noticed quickly, often within minutes of receiving a dose of the tainted drug. However, some patients undergoing cardiac surgery experience a decrease in blood pressure well into the procedure.

If you believe that you or a loved one has suffered an adverse reaction to Heparin, contact us to help you find out why.