Consumer Alert: Baxter's Heparin Investigated for Severe Allergic Reactions and Death
February 29, 2008
Heparin sodium is an anticoagulant, commonly known as a blood thinner, which prevents blood clot formation and stops blood clots from growing larger. It is frequently given intravenously to patients undergoing kidney dialysis and heart surgery and to treat or prevent other serious medical conditions, like deep venous thrombosis and pulmonary emboli.
Recently, serious adverse events have been reported in patients who received heparin manufactured by Baxter HealthCare Corporation, a company that manufacturers about half of the heparin used in the United States and sells about $30 million every year in the United States.
The adverse events usually occur very shortly after high-dose heparin therapy is given. These adverse events include severe allergic-type hypersensitivity reactions such as severe hypotension that may result in death. Other types of adverse reactions that have occurred include swelling, nausea, vomiting, sweating, shortness of breath. In fact, from mid-December 2007 through January 2008, over 350 adverse advents were reported with Baxter's heparin usage, including four deaths.
Due to the large increase in reported adverse events, in January 2008, the FDA inspected Baxter's manufacturing plant in New Jersey, and Baxter decided to recall nine lots of their multiple-dose heparin vials. According to the FDA, reports of serious adverse events have continued to pour in, indicating that the adverse events were not limited to patients receiving only the recalled lots of heparin. Thus, Baxter announced on February 11, 2008 that it would suspend production of multiple-dose vials of heparin.
While the cause of the adverse events is currently unknown, the investigation into heparin is now focused on whether the raw material for the drug, which is made from pig intestines and manufactured in China, was contaminated.
If you wish to speak to us about a potential claim or an injury caused by Heparin. The attorneys
at Paris & Chaikin, PLLC, are available to answer your questions.
Consultations are free with no obligations. CALL OUR FIRM TODAY
AT 212-742-0476.
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