Baxter International, Inc. announced that it is recalling all remaining lots and doses of its Heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products after the Food and Drug Administration (FDA) linked more deaths to the drug.

Details of the newest recall

Baxter had recalled nine lots of its heparin sodium injection multi-dose vials on January 17, 2008 due to a higher than usual number of reports of adverse patient reactions involving the product which has come under intense scrutiny after the Wall Street Journal published photos showing the horrific and unsanitary conditions of Chinese factories from where Baxter buys its raw Heparin.

Four deaths and hundreds of injuries have been linked to Heparin, a prescription injectable blood coagulant often used in hemodialysis (the filtering of blood) and cardiac invasive procedures, in the past month and the New York Times recently reported that the FDA may be attributing 17 additional deaths to Heparin use. According to the FDA, the company is now recalling all remaining lots of the drug, including

• Heparin sodium injection 5000 units/mL 10mL multi-dose vials
• Heparin sodium injection 10,000 units/mL 4mL multi-dose vials
• Heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials
• All HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free

This newest recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures.

Adverse reactions reported

The FDA, under fire for not inspecting the Chinese plant where these lots originated, has reported that adverse patient reactions, some of which may be severe and life-threatening, include:

Stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.

Additional information

For additional information, consumers may contact Baxter at 1-800-4-BAXTER (1-800-422-9837), or go their website: www.baxter.com. To view the FDA’s press release on the latest recall, go to: http://www.fda.gov/oc/po/firmrecalls/baxter02_08.html.

If you’ve been injured due to Heparin use, contact an attorney to discuss your situation. The consultation is free and without obligation. To contact a qualified attorney whose practice focuses in this area of law, please click here.