A Message To Heparin Side Effect Victims
The Law Firm of Eric H. Weinberg is currently assisting individuals who believe they were injured as a result of heparin therapy. We are ready to help you. If you, or a family member, have suffered an allergic-type reaction, hypotension, or other serious side effect as a result of heparin therapy, please submit a Free Case Evaluation Form, or call us toll free at 1-877-934-6274. We pledge to bring our more than 20 years of experience litigating pharmaceutical drug cases to bear on your behalf.
Baxter Healthcare Recalls Heparin Due To An Increase In Serious Side Effects And Deaths
In January and February of 2008 Baxter Healthcare issued two separate heparin recalls due to a sharp increase in the number of reported serious and life-threatening side effects associated with the product. The side effects included severe allergic-like (also referred to as hypersensitivity or anaphylactic) reactions and hypotension (low blood pressure), and in some cases, death.
The recalls included Baxter’s multi-dose and single-dose vials of heparin sodium for injection and HEP-LOCK heparin flush products.
According to the FDA, heparin side effects (or adverse events) included difficulty breathing, nausea, vomiting, diarrhea, abdominal pain, angioedema, excessive sweating, and rapidly falling blood pressure, capable of leading to life-threatening shock.
Baxter Healthcare also reported heparin side effects which included stomach pain and discomfort; nausea; vomiting; diarrhea; decreased or low blood pressure; chest pain; fast heat 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.
Patients experienced these symptoms almost immediately to shortly after receiving a heparin injection.
What Went Wrong - Baxter Heparin Products Were Contaminated With Oversulfated Chondroitin Sulfate (OSCS)
After extensive testing, FDA scientists discovered that the heparin active pharmaceutical ingredient (API), used to make the finished heparin product and produced in China, was contaminated with a compound known as oversulfated chondroitin sulfate (OSCO). The OSCO contaminant was found in heparin crude materials, heparin active pharmaceutical ingredient, and the finished heparin drug products.
Further research demonstrated that OSCO activates enzymes in the body, which are capable of generating inflammatory mediators. (See New England Journal of Medicine) These mediators in turn, led to the allergic-like symptoms and/or low blood pressure.
Because oversulfated chondroitin sulfate is an inexpensive compound that mimics the biological activity of heparin, it is speculated that the contaminant was added during the manufacturing process of the heparin active pharmaceutical ingredient by manufacturer Changzhou SPL, China.
Patients Affected By Recalled Heparin
Heparin belongs to a class of drugs called anticoagulants, or more commonly known as blood thinners. Heparin is administered to decrease the ability of the blood to clot. It is administered to patients to treat or prevent blood clots in veins, arteries, and lungs (pulmonary embolism); and to patients undergoing certain coronary surgeries, kidney patients undergoing dialysis, and in procedures known as photopheresis and plasmapheresis.
As expected, many of these adverse events occurred in patients receiving heparin at hemodialysis centers, and adverse events in patients receiving heparin during cardiac surgeries and photopheresis were also reported to the FDA.
Other Heparin Products Affected By The Recall
Additional companies that recalled heparin-containing products included American Health Packaging, B. Braun, Covidien, Medtronic, and Atrium Medical.
The FDA’s Center for Devices and Radiological Health received numerous reports of adverse events associated with heparin lock flush solutions and medical devices coated with or containing heparin. For more information, please see Center for Devices and Radiological Health Questions and Answers.
Free Legal Case Evaluation
If you or a loved one were injured as a result of heparin therapy, please submit a Free Case Evaluation Form, or call us toll free at 1-877-934-6274 to learn about your legal rights. Since 1988, the Law Firm of Eric H. Weinberg has represented hundreds of individuals injured by defective drug and medical device products. The firm has played a leading role in the litigation of high-profile drug lawsuits including Vioxx, Baycol, and blood products, recovering over $750 million on behalf of the firm's clients. |
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