Navigation Links
Mix-Up Behind FDA's Failure to Inspect China Blood-Thinner Plant
Date:2/18/2008

erse events linked to use of the injected heparin.

The FDA has an ongoing inspection at Baxter's plant in Cherry Hill, N.J., and at Baxter's supplier, Scientific Protein Labs in Waunakee, Wisc, Rogers said during Monday's teleconference. Starting this week, the FDA also begins investigating the correct plant in China, which makes the active pharmaceutical ingredient in heparin, he said.

"The inspection team will be conducting good manufacturing practicing inspection at the Chinese facility," Rogers said. "The inspection is designed to determine if the Chinese firm is in compliance with FDA regulations. We'll also be focusing on the firm's manufacturing process and how it adheres to the drug applications," he said.

Since the end of December, there have been about 350 reports of adverse reactions associated with Baxter's heparin product. This compares with less than 100 reports of adverse reactions in all of 2007.

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.

It's not clear how long Baxter's production of injectable heparin will be stopped. The one thing that is clear is that the stoppage could lead to a shortage of heparin, which is used to prevent blood clots in such patients as those undergoing kidney dialysis and heart surgery, U.S. health officials said.

More information

For more on heparin, visit the U.S. National Library of Medici
'/>"/>

Copyright©2008 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. High and mighty: first common height gene identified by researchers behind obesity gene finding
2. Lung Cancer Alliance Stands Behind CT Screening for Lung Cancer
3. The science behind the food we eat and the earth on which it grows
4. Plastic Surgery 2007: Where Truth Behind Emerging Cosmetic Treatments Meets Amazing Reconstructive Advances
5. Second pathway behind HIV-associated immune system dysfunction identified
6. Nationally Recognized Corporations and Retailers Rally Behind breastcancer.org
7. P&G Reports EPS of $0.92, Up 16% Behind 8% Sales Growth
8. Researchers chart the genetic mechanisms behind the genesis of fat cells
9. NCPA President Steve Girouxs Testimony at FDA Behind the Counter Hearing
10. Theres More Than Turkey Behind Holiday Yawns
11. Researchers led by Penn vet uncover the delicate protein balance behind the immune system response
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Mix-Up Behind FDA's Failure to Inspect China Blood-Thinner Plant 
(Date:9/18/2014)... 18, 2014 After years of shooting at ... firing range berms were saturated with lead, which increased the ... in the berm and send metal fragments back at the ... splashback, and the greater the potential for injury to officers. ... to remove lead from the range environment. , ...
(Date:9/18/2014)... September 18, 2014 Sutter Health’s California ... founder of Dolby Laboratories, by naming the Ray Dolby ... of Ray Dolby provided a founding gift of $21 ... which provides services to patients and families suffering from ... people have been treated at the center since its ...
(Date:9/18/2014)... September 18, 2014 On August 23, ... Glenn with the Distinguished Service Award for his ... at the 2014 National Basketball Retired Players Association (NBRPA) ... drafted by the Chicago Bulls in 1977, Glenn would ... New York Knicks, the Atlanta Hawks, and the Milwaukee ...
(Date:9/18/2014)... MD Complete , the breakthrough ... prescription, announced today that SHAPE Magazine has named ... Peel” in its annual Beauty Awards. The issue is ... products as tested by SHAPE’s expert team. , SHAPE ... Among the thousands of beauty products launched every year, ...
(Date:9/18/2014)... September 18, 2014 Unitek ... by the Accrediting Commission of Career Schools and ... body awarded Unitek College’s community outreach efforts with ... in Community Service Award. , Unitek College ... service-learning opportunities through our Community OutReach Educational (CORE) ...
Breaking Medicine News(10 mins):Health News:Firing Range Safety is Ohio DOC Priority 2Health News:Firing Range Safety is Ohio DOC Priority 3Health News:Sutter Health’s CPMC announces Ray Dolby Brain Health Center 2Health News:Sutter Health’s CPMC announces Ray Dolby Brain Health Center 3Health News:The HearStrong Foundation Recognizes Mike “Stinger” Glenn with the Distinguished Service Award at the 2014 Legends World Sports Conference 2Health News:The HearStrong Foundation Recognizes Mike “Stinger” Glenn with the Distinguished Service Award at the 2014 Legends World Sports Conference 3Health News:MD Complete Wins Shape Beauty Award for Best Peel 2Health News:Unitek College Receives Award for Community Service Initiatives 2Health News:Unitek College Receives Award for Community Service Initiatives 3Health News:Unitek College Receives Award for Community Service Initiatives 4
... lymph node metastasis in patients with pancreatico-biliary carcinoma has ... and shorter survival term. , This study, performed by ... Young Chul Kim, is described in a research article ... the World Journal of Gastroenterology. , The study evaluated ...
... ALLEGAN, Mich., May 20 Perrigo Company,(Nasdaq: ... Papa, Perrigo,s,Chairman and CEO will present at the ... May 21, at 10:00 a.m. (ET) at the ... the following link, http://www.veracast.com/webcasts/citigroup/healthcare08/25105341.cfm ., Perrigo ...
... May 20 Pennsylvania, along,with 28 other states ... million,settlement, the largest ever for a multi-state consumer ... advertising related to the,drug, Vioxx. Pennsylvania will receive ... Corbett said that in 1999, Merck allegedly,launched an ...
... May 20 Depression is a serious,but treatable health ... condition will be the focus of a national campaign ... Depression, which is,supported by the Anthem Blue Cross Foundation, ... Men Get Depression National Awareness Campaign is an effort ...
... life, it may be better than standard oxygen therapy, study ... suggests that a mechanical ventilator can ease suffering and help ... , A large percentage of these patients didn,t want to ... to wear an oxygen mask. But those who were willing ...
... Against Tobacco Recognized Nationally-, WASHINGTON, May 20 ... Regional Youth Advocate of the Year,by the Campaign for ... Michelle is being honored at a gala in the ... international grant winner,three other regional winners and a group ...
Cached Medicine News:Health News:Pennsylvania Attorney General Corbett Announces a Multi-state, $58 Million Settlement With Merck Over Deceptive Advertising Concerning the Safety of Vioxx 2Health News:Anthem Blue Cross Foundation Supports National Campaign Focused on Depression Among Men 2Health News:Anthem Blue Cross Foundation Supports National Campaign Focused on Depression Among Men 3Health News:Ventilator Relieves Lung Cancer Pain in Final Hours 2Health News:Ventilator Relieves Lung Cancer Pain in Final Hours 3Health News:Campaign for Tobacco-Free Kids Honors Michelle Mays of Rhinelander, WI As Youth Advocate of the Year 2
(Date:9/18/2014)... MELBOURNE, Australia , Sept. 18, 2014 /PRNewswire/ ... the appointments of Dr. Ashraf Hanna , M.D., ... to its Board of Directors. Dr. Hanna is the ... Genentech and Chief Financial Officer for the Genentech Foundation, ... and Global Head of Business Development and Licensing for ...
(Date:9/18/2014)... Relmada Therapeutics, Inc., (OTCQB: RLMD), a clinical-stage ... pain, announced today that it has appointed Mr. ... Director of Clinical Development. During his extensive ... led successful global clinical operations teams, in the US ... clinical development of numerous therapeutics and diagnostics across a ...
(Date:9/18/2014)... /CNW/ - A new expert panel report, Improving Medicines ... released today by the Council of Canadian Academies, addresses ... children. Each year about half of Canada,s ... prescription drug. Much of this prescribing is done off-label ... potential health risks. Children have historically been ...
Breaking Medicine Technology:Nexvet Appoints Ashraf Hanna and Joseph McCracken to Board of Directors 2Nexvet Appoints Ashraf Hanna and Joseph McCracken to Board of Directors 3Relmada Therapeutics, Inc. Appoints Christopher W. James As Senior Director of Clinical Development 2Studying medicines in children is always possible and is in their best interest, finds Expert Panel 2Studying medicines in children is always possible and is in their best interest, finds Expert Panel 3
... publication in prominent peer-reviewed journal highlights,findings of ... infection, EVANSTON, Ill., March 17 ... using a,rapid molecular diagnostic test is effective ... published in the Annals of Internal Medicine,by ...
... on Track to Initiate Phase 2b in Second Quarter ... - Conference Call Tomorrow at 8:00 a.m. ... Ardea Biosciences, Inc.,(Nasdaq: RDEA ) today announced positive ... RDEA806, its novel,investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in,patients ...
Cached Medicine Technology:Evanston Northwestern Healthcare Researchers Explain Effects of Large-Scale, Universal MRSA Surveillance Program That Supports Expanded Intervention 2Evanston Northwestern Healthcare Researchers Explain Effects of Large-Scale, Universal MRSA Surveillance Program That Supports Expanded Intervention 3Ardea Biosciences Reports Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating up to 2.0 Log Reduction in Plasma Viral Load 2Ardea Biosciences Reports Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating up to 2.0 Log Reduction in Plasma Viral Load 3Ardea Biosciences Reports Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating up to 2.0 Log Reduction in Plasma Viral Load 4
... hands play an important part in our ... and rheumatic changes can cause severe handicaps. ... the finger-joint prostheses was to produce a ... natural function as nearly possible.,The cementless RM ...
... hands play an important part in our ... and rheumatic changes can cause severe handicaps. ... the finger-joint prostheses was to produce a ... natural function as nearly possible.,The cementless RM ...
... precise control of the thigh during varus/valgus manipulation ... the proximal thigh during ACL or PCL procedures. ... on both right and left legs and may ... Holder can be used with an Arthrex tourniquet ...
... for trauma, foot and ankle or deformity ... External Fixation components are designed to reduce ... the complexity of intra-operative and post-operative frame ... and hinges eliminate the need to stock ...
Medicine Products: