Heparin

Heparin is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. The blood thinner drug made by Baxter International Inc. has caused severe side effects including: stomach pain or discomfort, nausea, vomiting, diarrhea, descreased 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.

On June 1, 2008 the FDA updates its reports of deaths associated with Heparin use to include 86 deaths in the United States. In addition, hundreds of patients worldwide have suffered severe reactions linked to contaminated Heparin. The FDA sent a warning letter on April 21, 2008 to Baxter’s supplier in China, Changzhou SPL, identifying production problems including use of unclean tanks to make Heparin, raw materials received from an unacceptable vendor and no adequate way to remove impurities. Heparin is derived from the mucous membranes of the intestines of slaughtered pigs that are often cooked in inregulated family workshops in China. The FDA has also recalled Heparin that comes in prefilled syringes made by AM2PAT, Inc. that were distributied under three product labels: Sierra Prefilled, AM2PAT and B. Braun. These prefilled sytringes were thought to have become contaminated at a manuafctuing facility in North Carolina.

Baxter sold Heparin that was defective due to contamination and inadequate inspection of its product. Baxter allegedly failed to undertake adequate testing that would have shown that its Heparin posed a life-threatening risk to patients. Please contact Nix & McIntyre LLP for a free consultation via our online form or (866) 917-5200.