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

ompleted its inspection of Scientific Protein Laboratories' Changzhou SPL plant. The plant was no longer producing heparin, inspectors found. The inspectors did find deficiencies in the way the plant removed impurities and dealt with testing results that didn't meet specifications. In addition, they found problems in waste disposal and equipment, according to the FDA.

Since the end of December, there have been 785 reports of adverse reactions associated with Baxter's heparin product. This compares with less than 100 reports of adverse reactions in all of 2007.

There also have been 46 deaths, four of which were associated with an adverse reaction to heparin, according to the FDA.

Most of the reactions have taken place at hemodialysis centers, almost exclusively involving patients receiving a "bolus dose," which is a high dose administered over a short period of time, according to the FDA.

Adverse reactions included difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, which can lead to life-threatening shock. These reactions have been seen with as few as several thousand units per milliliter of heparin, and as much as 50,000 units per milliliter.

More information

For more on heparin, visit the U.S. National Library of Medicine.



SOURCES: March 5, 2008, teleconference with Janet Woodcock, M.D., Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer, and Acting Director of the Center for Drug Evaluation and Research, U.S. Food and Drug Administration; March 5, 2008, teleconference with Ray Godlewski, vice president of quality for Baxter's medication delivery business; March 5, 2008, prepared statement, Scientific Protein Laboratories, Waunakee, Wisc.


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved

0

GOOD

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:5/24/2013)... (PRWEB) May 24, 2013 Ten Seattle’s ... area. The stores were fabricated and installed over the ... company, Palomar Modular Buildings . , “The custom ... Coffee group. They made a conscious decision to utilize ... the company with the build quality they wanted, and ...
(Date:5/24/2013)... With today’s levels of weight gain and obesity ... the causes of weight gain and how to lose weight ... of weight gain and treatments that will help patients lose ... by the Child Study Center at NYU Langone Medical Center ... ADHD and the soring rates of obesity later in life. ...
(Date:5/24/2013)... Health Concern have today released updated guidelines on Hormone ... of HRT, the benefits and the risks. The new ... International , published by SAGE. , Over the ... the "elixir of youth" to being considered extremely risky ... the publication of the Women,s Health Initiative (WHI) trial ...
(Date:5/24/2013)... DiaperBuys.com is pleased to announce the winners of ... Olathe, Kansas, won the grand prize: a six-month supply ... a three-month supply of Cuties diapers and was awarded ... prize, a one-month supply, went to Chris Calderon of ... company’s Facebook page. Entrants uploaded their cutest baby photos ...
(Date:5/24/2013)... CA (PRWEB) May 24, 2013 ... today of the latest update involving allegations that ... Zmax SR (azithromycin) can allegedly cause potentially ... Company reported on May 17, 2013* that Health ... Administration in warning that Zithromax can cause abnormal ...
Breaking Medicine News(10 mins):Health News:Seattle’s Best Coffee Gets Modular 2Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Now Help Patients with Weight Gain Linked to Childhood ADHD Lose Weight Fast 2Health News:DiaperBuys.com Announces Photo Contest Winners 2Health News:2013 Alleged Zithromax Arrhythmia and Sudden Death Cases Update: Canadian Health Officials Issue Warning 2Health News:2013 Alleged Zithromax Arrhythmia and Sudden Death Cases Update: Canadian Health Officials Issue Warning 3Health News:2013 Alleged Zithromax Arrhythmia and Sudden Death Cases Update: Canadian Health Officials Issue Warning 4
... CoLucid Pharmaceuticals, Inc., an,innovative biotechnology company ... announced it closed a $25 million Series ... round, which included previous investors,Pappas Ventures, Domain ... Ventures. The financing will be used to ...
... subjective decision-making , ... Los Angeles (PRWEB) July 1, ... their patients who have a heart abnormality called myocardial bridging and ... Cedars-Sinai Medical Center, the University of Texas Medical Branch and RWTH ...
... and the first day of summer is upon us, the cancer care ... the sun when spending time outdoors. Although the most prevalent cancer in ... majority of the more than 1 million annual U.S. cases of skin ... ...
... have developed a series of tests that for the first ... smell (olfactory function) in young children, according to a new ... Head and Neck Surgery . , The study, authored ... can identify a majority of 16 different test odorants that ...
... Center, Atlanta, Georgia, "Elimination of Health ... Professionals", WASHINGTON, July 1 The ... Association:, WHAT: The nation,s largest and ... minority and underserved populations, the National,Medical Association ...
... TITUSVILLE, N.J., June 30 Janssen, Division,of Ortho-McNeil-Janssen ... generic version of RISPERDAL(R) (risperidone),through Patriot Pharmaceuticals, L.L.C., ... companies are a part of the,Johnson & Johnson ... it will continue to make available branded,RISPERDAL, which ...
Cached Medicine News:Health News:CoLucid Pharmaceuticals Announces $25 Million Series B Financing for Advancement of First-in-Class Migraine Compound 2Health News:CoLucid Pharmaceuticals Announces $25 Million Series B Financing for Advancement of First-in-Class Migraine Compound 3Health News:CoLucid Pharmaceuticals Announces $25 Million Series B Financing for Advancement of First-in-Class Migraine Compound 4Health News:New System Devised To Guide Doctors Treating Patients With Symptomatic Myocardial Bridging 2Health News:New System Devised To Guide Doctors Treating Patients With Symptomatic Myocardial Bridging 3Health News:New System Devised To Guide Doctors Treating Patients With Symptomatic Myocardial Bridging 4Health News:Texas Oncology Urges Texans to ‘Save Your Skin:' Outsmart the Sun and Prevent Skin Cancer 2Health News:Texas Oncology Urges Texans to ‘Save Your Skin:' Outsmart the Sun and Prevent Skin Cancer 3Health News:Texas Oncology Urges Texans to ‘Save Your Skin:' Outsmart the Sun and Prevent Skin Cancer 4Health News:National Medical Association Hosts the 2008 Annual Convention and Scientific Assembly 2Health News:Janssen Announces Launch of Authorized Generic for RISPERDAL(R) 2Health News:Janssen Announces Launch of Authorized Generic for RISPERDAL(R) 3Health News:Janssen Announces Launch of Authorized Generic for RISPERDAL(R) 4
(Date:5/24/2013)... China Biologic Products, Inc. (Nasdaq: CBPO, "China Biologic" or ... in China , today announced that ... issued by Shanghai RAAS Blood Products Co., Ltd. ("Shanghai ... that on May 21, 2013, Ms. Siu ... shareholders of the Company, and her spouse, Mr. Tung ...
(Date:5/24/2013)... , May 24, 2013  Auxilium Pharmaceuticals, Inc. (Nasdaq: ... will participate in the Deutsche Bank Health Care Conference ... Waterfront Hotel.  Mr. Adrian Adams , ... an overview of the Company and its product pipeline ...   (Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO ) ...
(Date:5/24/2013)... YORK , May 24, 2013 In accordance ... Rules and Rule 14e-1 of the United States Exchange Act, ... its original offer for Elan Corporation (NYSE: ELN). ... Limited ("Royalty Pharma") made an offer for the entire of ... Corporation, plc ("Elan") (the "Original Offer").  On ...
Breaking Medicine Technology:China Biologic Comments on the Proposed Shanghai RAAS Transaction 2China Biologic Comments on the Proposed Shanghai RAAS Transaction 3China Biologic Comments on the Proposed Shanghai RAAS Transaction 4Auxilium Pharmaceuticals, Inc. To Present At The Deutsche Bank Health Care Conference 2Auxilium Pharmaceuticals, Inc. To Present At The Deutsche Bank Health Care Conference 3Auxilium Pharmaceuticals, Inc. To Present At The Deutsche Bank Health Care Conference 4Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 2Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 3Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 4Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 5Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 6Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 7Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 8Royalty Pharma Discloses Acceptance Levels of Original Offer for Elan Pursuant to Irish and United States Regulatory Requirements 9
... InfoLogix, Inc. (Pink Sheets: IFLG ), ... the healthcare and commercial industries, announced today that it ... Faire and Regional Conference, sponsored by HIMSS South Florida ... Grand Hotel in Davies, FL (situated North of Miami) ...
... Mass., Oct. 25 GENFIT (Alternext: ALGFT; ISIN: FR0004163111), ... and development, focusing on the early diagnosis and preventive ... it has been selected by Windhover as one of ... the cardiovascular/metabolic category. This announcement is part of the ...
Cached Medicine Technology:InfoLogix to Present at South Florida Healthcare Trade Faire & Regional Conference 2GENFIT Selected by Windhover for the 2011 'Top Biopharma Projects To Watch' 2GENFIT Selected by Windhover for the 2011 'Top Biopharma Projects To Watch' 3
... designed specifically for posteror ... injection of silicone oil ... Special high pressure tubing ... cannula. May also be ...
Product designed specifically for posteror segment surgical procedures. Facilitates posterior segment infusion. Flexible tubing 10in (25cm)....
For surgical treatment, repair and irrigation of the nasolacrimal system. Stainless steel probes, 23G x4 1/2in (.60mm x 11cm) Silicone tubing, length 14in (35cm), ID: .012in (.30mm) OD: .025in (.60mm...
...
Medicine Products: