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.
|SOURCE Baxter Healthcare Corporation|
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