In February of 2008, Baxter International Inc. announced that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single dose vials, and HEP-LOCK heparin flush products. Heparin is a blood thinner that helps prevent the formation of blood clots. The drug has now been connected to numerous deaths and severe allergic reactions due to contamination with oversulfated chondroitin sulfate. Nearly all reported adverse reactions have occurred when the product has been used for renal dialysis, invasive cardiovascular procedures, and apheresis procedures.
Heparin is made from a natural source of pig intestines which has grown to be a striving industry in China where Baxter has one of its American controlled plants and where the problem has been reported to originate. This Chinese plant would source raw materials (pig parts) from areas throughout China that have been accused of being unsanitary and not regulated. An FDA investigation found that the drug lots linked to deaths contained an altered version of a dietary supplement made from animal cartilage and is a cheaper alternative to raw heparin. This compound is man-made and is commonly known as over-sulfated chondroitin sulfate. This very abundant and cheap to make compound mimics heparin when tested but is not naturally occurring and not something that would normal be included in the normal production of the drug. It is also not approved by the FDA to be used in drug manufacturing. These drug lots are suspect to have originated from the Chinese plant and from one of its sources in the region.
Reported adverse patient reactions 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.
Baxter International Inc. is not the only company that has been linked to contaminated lots of heparin via a Chinese supply chain. Many other companies have responded by recalling their products worldwide. Our defective drug attorneys are ready to consult with you on your dangers and defective drug case. If you or someone you know has been exposed to contaminated heparin, feel free to contact the trial lawyers at Keefe Bartels to discuss your legal rights regarding personal injuries or health risks from contaminated heparin.