Baxter Provides Update on Heparin Reactions
Company Provides Additional Instructions to Clinicians to Mitigate Risk of Reaction While Working to Identify Root Cause
Baxter Healthcare Corporation is providing an update to its January 2008 heparin sodium injection 1,000 units/mL 10 and 30mL multi-dose vial voluntary recall of nine lots, which the company initiated as a precautionary measure due to an increase in reports of adverse reactions that may be associated with the drug. Since the recall, Baxter has received reports of similar adverse reactions occurring in other lots of 1,000 units/mL, 10 and 30mL multi-dose vials; 5,000 units/mL and 10,000 units/mL multi-dose vials; and 5,000 units/mL single-dose vials when single doses were combined to create a larger bolus dose.
Nearly all reported adverse reactions have occurred in three specific areas of product use – hemodialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: 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 and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.
In cooperation with the U.S. Food and Drug Administration (FDA), Baxter is conducting a thorough investigation to determine the cause of the increase in the number of reported adverse reactions. Baxter has temporarily suspended the manufacture of multi-dose heparin vials as the company works to determine the cause of the increase in adverse reactions.
In agreement with FDA, Baxter is continuing to distribute these products to assure adequate supply in the market, and is therefore not recalling any additional lots of heparin at this time. Given the widespread use of this critical anticoagulant (frequently called a blood thinner) and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, the removal of Baxter’s heparin from the market would create more risk to the population of patients requiring heparin therapy than the increased potential for experiencing an adverse reaction.
Health care professionals may continue to prescribe Baxter’s heparin sodium injection, but are being advised to: balance the clinical need to use these products with the increased potential for experiencing adverse drug reactions; use the lowest dose necessary to achieve the minimum required level of anticoagulation; avoid administering bolus doses if possible; be aware of the increased potential for adverse drug reactions to occur, including profound and refractory hypotension; be advised to implement measures that allow prompt identification and treatment of the signs and/or symptoms of adverse reactions; and, as profound and/or refractory hypotension may occur, particularly with higher doses or infusion rates of intravenous heparin, frequent monitoring of vital signs and resuscitative therapy should be present and available throughout heparin administration.
Customers with questions may contact the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives will be available twenty-four hours a day, seven days a week.
Baxter sells approximately 35 million units of heparin sodium injection multi and single dose vials per year in the United States, with an annual sales value of approximately $30 million.
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