Navigation Links
FDA Finds Contaminant in Baxter's Recalled Heparin Products
Date:3/5/2008

But officials can't say if it's responsible for adverse events, deaths reported

WEDNESDAY, March 5 (HealthDay News) -- Tests have found a heparin-like contaminant in heparin blood-thinning products made by Baxter Healthcare Corp. that have been linked to hundreds of adverse reactions and at least four deaths in the United States, federal health officials said Wednesday.

"While the FDA has not determined the root cause of the adverse events, we have found a heparin-like compound, which is not heparin, present in some of the active pharmaceutical ingredients produced by Scientific Protein Laboratories," Dr. Janet Woodcock, acting director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, said during an afternoon teleconference.

Ray Godlewski, vice president of quality for Baxter's medication delivery business, said during a subsequent teleconference that "all the contaminated heparin came from China."

Scientific Protein Laboratories, of Waunakee, Wisc., and its Changzhou SPL plant in Changzhou City, China, is Baxter's main supplier of the active pharmaceutical ingredient in heparin, Woodcock said.

"This contaminant is present in significant quantities in some of the active pharmaceutical ingredients, accounting for approximately 5 to 20 percent of the substance tested," Woodcock said.

The substance reacts like heparin in the conventional tests that are used for heparin, which is why those tests of ingredients might not detect the contaminant, Woodcock said.

Heparin is a blood-thinner whose main ingredient comes from pig intestines. The drug is often given to dialysis patients and people undergoing heart surgery.

"At this point, we do not know how the heparin-like compound got into a heparin active pharmaceutical ingredient," Woodcock said. "Whether it was deliberately or accidentally added it is not known," she added.

The tests th
'/>"/>

Copyright©2008 ScoutNews,LLC.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Aromatherapy Falls Short, Study Finds
2. High Numbers of Children With Special Needs Have Health Insurance, Regular Caregivers, HRSA Survey Finds
3. Diamonds Retirement Study Finds Companies Ill-Prepared to Meet Baby Boomers Health and Wealth Needs
4. Genome-wide association study on Parkinsons disease finds public home at NIH
5. Low-intensity exercise reduces fatigue symptoms by 65 percent, study finds
6. U of Minnesota study finds thalidomide shows promise for treatment of recurrent ovarian cancer
7. Joslin study finds restricting insulin doses increases mortality risk
8. Study Finds Variations in Doses of Radiation Therapy
9. Despite popularity, researcher finds not everyone can successfully learn through online courses
10. Study finds recent trend of growing US disparities in health not inevitable
11. Hebrew SeniorLife researcher finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2014)... (PRWEB) July 23, 2014 The Centers for ... in prescription drug deaths from 2010 to 2012. Formerly ... its minimal monitoring of access to some of the strongest ... hands. Florida’s law enforcement launched an initiative to crack ... nonexistent compared to the 65 that existed in the state ...
(Date:7/23/2014)... has identified three genetic changes linked to an increased ... University investigators, was published online July 20 in ... of the most common malignancies among women worldwide, most ... have focused on women of European ancestry. , Given ... East Asian women and those of European ancestry, the ...
(Date:7/23/2014)... 23, 2014 The Circuelle Foundation ... academic institutions uncovering the importance of breast self-exams ... need for breast self-exams is contradictory and can ... today for keeping this healthy ritual. , “Women ... the significance of breast self-exams and becoming breast ...
(Date:7/23/2014)... Louis (PRWEB) July 23, 2014 Five years ... its doors there were few options for babies diagnosed with ... delivery, or travel across the country for innovative fetal therapies. ... Fetal Care Institute to care for their babies in the ... surgeries and interventions. , “A number of the babies ...
(Date:7/23/2014)... 2014 Beverly Hills plastic surgeon ... procedures to patients who want to rejuvenate their looks. ... any part of the face, Dr. Diamond empowers patients ... Throughout life, facial skin and structure develop wrinkles, sagging ... they really are. Each patient is different in terms ...
Breaking Medicine News(10 mins):Health News:Florida’s Crackdown on Pill Mills Has Led to Rise in Popularity of Synthetic Drugs; Suncoast Rehab Educates on Dangers of These Drugs in Adolescents 2Health News:Florida’s Crackdown on Pill Mills Has Led to Rise in Popularity of Synthetic Drugs; Suncoast Rehab Educates on Dangers of These Drugs in Adolescents 3Health News:Florida’s Crackdown on Pill Mills Has Led to Rise in Popularity of Synthetic Drugs; Suncoast Rehab Educates on Dangers of These Drugs in Adolescents 4Health News:Vanderbilt-led study identifies genes linked to breast cancer in East Asian women 2Health News:Historical and Current Research Points to Importance of Breast Self-Exams 2Health News:St. Louis Fetal Care Institute Marks Five Years of Life Changing Care and Fetal Surgery 2Health News:Beverly Hills Plastic Surgeon, Dr. Diamond, is Now Offering Facial Plastic Surgery Procedures 2
... 30 Contrary to prevailing,assumptions, children are more vulnerable ... of 6 than they are in early childhood, according ... presented May 4,at the annual meeting of the Pediatric ... about protecting toddlers from lead,exposure, our study shows that ...
... members, PHOENIX, April 30 Gov. Janet ... the state Medicaid program to,expend moneys to provide ... by Sen. Barbara Leff (R-Paradise Valley), SB 1418 ... Fund and will provide benefits,for nicotine replacement therapies ...
... heart rate variability, researchers report, , , WEDNESDAY, April 30 ... that the electromagnetic field produced by incubators affect the ... Whether these changes in cardiac rhythms have long-term effects ... infants who can spend several weeks or months in ...
... and Their Contacts, Underscored by Research Led by ... April 30 The high costs of hospitalizing,young ... in the,United States, underscoring the importance of preventive ... they have regular contact, according to,research led by ...
... -- Pelvic organ prolapse a tear or weakness in ... to fall outside the body runs in families, a ... family member who has had a hernia or prolapse ... body opening are more likely to develop prolapse themselves, says ...
... Osteotech, Inc.,(Nasdaq: OSTE ), a leader in ... announced today that it has signed an exclusive,distribution ... 1,2008, under which BioHorizons will market Osteotech,s bone ... in Europe, the Middle East,Latin America and Asia. ...
Cached Medicine News:Health News:Children More Vulnerable to Harmful Effects of Lead at Age 6 Than as Toddlers, Says New Study 2Health News:Children More Vulnerable to Harmful Effects of Lead at Age 6 Than as Toddlers, Says New Study 3Health News:Governor Napolitano Signs Smoking Cessation Bill 2Health News:Incubators Affect Newborns' Heart Rates 2Health News:Young Children Hospitalized for Flu Associated With Higher Costs and Higher Risk Illness 2Health News:Young Children Hospitalized for Flu Associated With Higher Costs and Higher Risk Illness 3Health News:Family history places women at risk of pelvic organ prolapse, SLU research finds 2Health News:Osteotech Engages BioHorizons as Exclusive Distributor to International Dental Market 2
(Date:7/23/2014)... , July 23, 2014  MiMedx Group, Inc.  ... processor and marketer of patent-protected regenerative biomaterials and ... it has filed its initial Investigational New Drug ... ("FDA").   The IND submission, which ... Company,s initial submission for certain indications of its ...
(Date:7/23/2014)... , July 23, 2014 ... of the "Prepackaged Medical Kits and Trays ... their offering. http://photos.prnewswire.com/prnh/20130307/600769 ... markets for Prepackaged Medical Kits and Trays in ... Custom Trays, Ophthalmic Custom Trays, Custom Basin Kits, ...
(Date:7/23/2014)... , July 23, 2014 Sinovac Biotech Ltd. (NASDAQ: ... in China , announced today that it ... and Prevention ("Beijing CDC") to be a supplier of the ... for 2014. The Beijing CDC plans ... seasonal flu vaccine this year from four domestic vaccine manufacturers ...
Breaking Medicine Technology:MiMedx Files Its Initial Investigational New Drug Application 2MiMedx Files Its Initial Investigational New Drug Application 3Prepackaged Medical Kits and Trays - Global Strategic Business Report: Updated 2014 Report 2Sinovac Receives Beijing CDC Tender to Supply Seasonal Flu Vaccine Anflu 2
... Feb. 16, 2011 New Mexico ... ), a developer of medical IT services and solutions that ... today the company will begin providing second opinion teleradiology interpretation ... "There is a solid market for patients and their families ...
... Fla., Feb. 16, 2011 One of America,s two largest ... pharmacy counters in nearly 3,000 stores.   To ... giving away through March 4 thousands of its bullet-shaped nasal ... bacteria.  Visit www.germbullet.com . "If you are ...
Cached Medicine Technology:New Mexico Software Initiates Medical Second Opinion Service via Telemedicine for Remote Consultation Review 2New Mexico Software Initiates Medical Second Opinion Service via Telemedicine for Remote Consultation Review 3Which Pharmacy Chain Offers GermBullet® Inhaler to Fight Exposure to Cold and Flu Viruses and Bacteria? 2
... Forma 1400 Series ... specifically to revolutionize working ... cabinet. The most comfortable, ... Class II cabinet on ...
... The Premier 12 Holter Analysis Kit incorporates ... Dispersion with other powerful DMS Holter analysis ... TWA analysis possible in less than 10 ... TWA, for visual verification and validation. The ...
... Designed for ease of use and patient ... smooth edges for comfort and is available ... to a perfect fit. For hard to ... trach collar to your specifications. Don't just ...
... more comfortable, and you will too., ... and to avoid the knotty problems associated ... ties, consider the Dale® Tracheostomy Tube Holder. ... narrow fastener tabs of the Dale® Tracheostomy ...
Medicine Products: