Heparin Vial Recall

Heparin sodium is an anticoagulant that prevents the blood cells from clotting, and is mostly administered intravenously. Patients who are most commonly given heparin are on kidney dialysis, have had cardiac surgery, and have received treatment or prevention of deep vein thrombosis and pulmonary emboli. Estimates have indicated that over one million multiple-dose vials of heparin are sold each month in the United States. About half of that heparin supply is believed to have been manufactured and distributed by Baxter International Inc.

Beginning in December of 2007, the FDA and Baxter International Inc. have been receiving reports regarding adverse reactions to heparin sodium vial products. Initially the reactions were reported from dialysis units. However, the list of patients who have been affected now includes cardiac surgical patients and patients who have undergone photopheresis. The number of those affected is over 350 and about 40% of the cases were considered as serious based upon preliminary and ongoing review.

In early January of 2008, the FDA and Baxter became aware of clusters of these adverse effects. As a result, on January 17, 2008 Baxter recalled 9 product lots. On that same day the FDA launched inspections of Baxter’s U.S. manufacturing plant and their processes. Since that initial recall, new reports have surfaced bringing to light that the adverse events were not only limited to the nine lots that had been recalled. Four patients have died since the adverse events were reported; however, the link between those patients’ deaths and the heparin used remains uncertain.

Reported adverse patient reactions have included; stomach pain, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate(tachycardia), 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 difficultly opening the mouth. Reactions that include profound and refractory hypotension can be severe and life threatening.

Baxter has provided a specific list of lot numbers for concerned individuals and organizations to review. If you are involved in a case that involves a heparin issue or potential heparin issue, please contact our office. We will make sure that your medical legal consulting needs are met in a manner that best fits your practice. Information for this article was gathered from www.FDA.gov.