Navigation Links
Baxter Provides Update on Heparin Reactions
Date:2/11/2008

Company Provides Additional Instructions to Clinicians to Mitigate Risk of

Reaction While Working to Identify Root Cause

DEERFIELD, Ill., Feb. 11 /PRNewswire-FirstCall/ -- 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.

Baxter International Inc. (NYSE: BAX), through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. For more information about Baxter, visit http://www.baxter.com.


'/>"/>
SOURCE Baxter Healthcare Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Baxters Costa Rica Facility Recognized With Shingo Prize for Excellence in Manufacturing
2. Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/mL 10 and 30mL Multi-Dose Vials
3. Baxter International Fourth Quarter 2007 Financial Results Conference Call
4. Baxter Announces FDA Approval of GELFOAM(R) Plus Hemostasis Kit
5. Baxter Receives 510(k) Clearance From FDA For V-Link With VitalShield, New Antimicrobial Intravascular Technology
6. Baxter Kidney Patient Education Program Celebrates Tenth Anniversary
7. Baxter Adds Recombinant Protein to Specialty Therapeutics Portfolio
8. Baxter and Novation Sign Multi-Year Contract Extension Valued at Over $200 Million for Medication Delivery Products
9. Baxter Named to Dow Jones Sustainability Index for Ninth Consecutive Year
10. Baxter and Halozyme Announce Collaboration for Development of Subcutaneous GAMMAGARD LIQUID(TM) Administration Using Enhanze(TM) Technology
11. Baxter to Launch GARDian(TM), a Groundbreaking Initiative That Helps Provide Continued Access to GAMMAGARD for Current Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... ... February 04, 2016 , ... Shimadzu Scientific Instruments will ... live demos and poster sessions, and present on the analysis of mycotoxins and ... March 6 to 10 at the Georgia World Congress Center in Atlanta, Georgia. ...
(Date:2/4/2016)... PARK, Calif. , Feb. 4, 2016   DelMar ... biopharmaceutical company focused on the development and commercialization of new ... 18 th Annual BIO CEO & Investor Conference ... in New York, NY . ... an update on the ongoing clinical trial of VAL-083 ...
(Date:2/4/2016)... 2016 Sinovac Biotech Ltd. ("Sinovac" or the ... biopharmaceutical products in China , today ... directors received on February 4, 2016 a preliminary non-binding ... comprised of PKU V-Ming ( Shanghai ) ... Qianhai Development ( Shenzhen ) Fund Management ...
(Date:2/3/2016)... 2016   ViaCyte, Inc ., a leading, ... stem cell-derived islet replacement therapy for the treatment ... announced that ViaCyte and Janssen Biotech, Inc., one ... Johnson, have agreed to consolidate the assets of ... provides ViaCyte with an exclusive license to all ...
Breaking Biology Technology:
(Date:1/25/2016)... SEATTLE , Jan. 25, 2016  Glencoe Software, ... biotech, pharma and publication industries, will provide the data ... Phenotypic Screening Centre (NPSC). ... Phenotypic analysis ... even whole organisms, allowing comparisons between states such as ...
(Date:1/22/2016)... 22, 2016 ... the "Global Biometrics Market in Retail ... --> http://www.researchandmarkets.com/research/p74whf/global_biometrics ) has ... Biometrics Market in Retail Sector 2016-2020" ... Research and Markets ( http://www.researchandmarkets.com/research/p74whf/global_biometrics ) ...
(Date:1/20/2016)... A market that just keeps on growing. Molecular Diagnostics ... genomics knowledge. Learn all about it in this new ... trends are pushing market growth and company valuations. Trends ... pathogen evolution - next generation sequencing - emergence of ... the role of genetic material in Disease and Health ...
Breaking Biology News(10 mins):