Navigation Links
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
Date:10/1/2009

facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.

"Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug," said Jenkins.

Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.

Prescription and over-the-counter medicines available in the United States must generally meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.

The monograph was revised, in part, in response to a 2007- 2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.

For more information

FDA Alert to Health Care Professionals

http://www.fda.gov//Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184502.htm

USP Heparin Information

http://www.usp.org/hottopics/heparin.html

'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. New Data to Support VELCADE(R) (Bortezomib) For Injection Based Therapies as Setting New Standards in The Care of Newly Diagnosed Patients With Multiple Myeloma
2. Virogenomics, Inc. Awarded $2 Million National Institute of Standards and Technology (NIST) Advanced Technology Program Grant to Develop Integrated Diagnostic Biosensors
3. Real-World Study Showed Cost Savings for VTE Prophylaxis with Enoxaparin Compared with Unfractionated Heparin (UFH)
4. Heparin Use Prior to Endoscopic Vein Harvest Improves Graft Patency in Off-Pump Coronary Artery Bypass Patients
5. Interface Biologics Anti-Thrombic Additives Show Equivalent Efficacy to Commercial Heparinized Coatings
6. ISAR-REACT 3 Pits Bivalirudin vs. Unfractionated Heparin in PCI
7. Study Shows That Low-Molecular Weight Heparin (LMWH) was Associated with Reduced Hospital Costs of Venous Thromboembolism (VTE) Treatment Compared with Unfractionated Heparin (UFH)
8. WaveSense Diabetes Products Safe from Maltose Inaccuracy Risks
9. BioInformatics, LLC New Report - Capitalizing on New Opportunities for Stem Cell Products, Now Available
10. Plasma Products Safe Despite Swine Influenza Outbreak, Assures International Biopharmaceutical Company Octapharma
11. Processed Tomato Products May Protect Against Inflammation, According to a Study Presented at the Experimental Biology Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2013)... May 24, 2013  Auxilium Pharmaceuticals, Inc. (Nasdaq: ... participate in the Deutsche Bank Health Care Conference to ... Hotel.  Mr. Adrian Adams , Chief ... overview of the Company and its product pipeline at ... (Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO ) The ...
(Date:5/24/2013)... May 24, 2013 The potential ... systemic delivery of therapeutic agents has been receiving undeniable ... delivery showing significant promise. The crucial formulation considerations for ... device play a major role in the efficiency of ... the development of new formulation techniques and devices in ...
(Date:5/23/2013)...  Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA ) ... Life Science Firm of the Year by the Tech Council ... at the TCM,s 25 th Annual Tech Awards Celebration ... Awards Celebration recognizes the leaders and innovators in the technology ... and the surrounding regions. "We are deeply ...
Breaking Medicine Technology:Auxilium 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 4Inhalaltion Drug Delivery: 11-12 September - Berlin, Germany 2Vanda Pharmaceuticals Named the 2013 Life Science Firm of the Year by the Tech Council of Maryland 2
... 2011 With the support of Key Opinion Leaders ... the time and attention of KOLs is intensifying. But ... landscape for creating and maintaining KOL and physician relationships. ... KOL landscape, Best Practices, LLC has published an updated ...
... Endo Pharmaceuticals (Nasdaq: ENDP ) announced today ... of President, HealthTronics Inc., effective Aug. 29, 2011. HealthTronics, ... urological products and services based in Austin, Texas. ... HealthTronics Group President James Whittenburg, who is staying through ...
Cached Medicine Technology:Pharma Medical Science Liaison Outreach Shifting Away from Traditional Company Sales Regions 2Endo Pharmaceuticals Announces Leadership Change at HealthTronics Subsidiary: Appoints Kelly Huang, Ph.D. New President 2Endo Pharmaceuticals Announces Leadership Change at HealthTronics Subsidiary: Appoints Kelly Huang, Ph.D. New President 3
(Date:5/25/2013)... It's not astonishing that holidays are ... demands are endless, from family, friends and co-workers. Between ... want more than their parents can afford, parties to ... comes graduations, birthdays, anniversaries and it seems like an ... ideas become tired and income can’t catch up to ...
(Date:5/25/2013)... Coral Springs, FL (PRWEB) May 25, 2013 ... for Dallas-Ft. Worth, Texas. It is the fifth largest media ... homes. Dallas is the number one visitor destination in Texas ... the cultural gateway to the American West as it is ... of activities everyone will enjoy from sports to the arts. ...
(Date:5/25/2013)... make great companions for senior citizens, but elderly people who ... more likely to crash than those who never drive with ... 2,000 licensed drivers aged 70 and older. The nearly 700 ... with their pet in the car. Among those who ... as high as among those who never drove with their ...
(Date:5/25/2013)... Louis, MO (PRWEB) May 25, 2013 Providing ... for the Diet Doc team of weight management professionals. But, ... fast and effectively, Diet Doc’s hCG diets ... factors like abuse during childhood like bullying, more control over ... directly capable of dealing with the underlying factors of weight ...
(Date:5/25/2013)... The latest report from BetterDigestion.org ... syndrome (IBS) to bloating, constipation, diarrhea and other ... embarrassing, frustrating and difficult health issues to resolve. ... have provided a cure for these troublesome ... to digestive health issues, a healthy diet is ...
Breaking Medicine News(10 mins):Health News:TheBeautyPlace.com Debuts Their Brand New Beauty Kits 2Health News:Communities of Distinction TV Presents May Air Dates for Dallas-Ft. Worth, Texas 2Health News:Seniors More Likely to Crash When Driving With Pet: Study 2Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Announces hCG Diet Plans for Those Suffering from Abuse-Related Weight Gain 2Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Announces hCG Diet Plans for Those Suffering from Abuse-Related Weight Gain 3Health News:Natural Foods For Digestive Health Report and Video Published by BetterDigestion.org 2
... medical care in Korea but can afford it least ... services, according to a Yale School of Medicine ... ,Low-income individuals with multiple chronic conditions ... because they need and use more services, said Jennifer ...
... been clearly described, but a new study from researchers ... a strong association between domestic violence and asthma. ... International Journal of Epidemiology, raises questions about the role ... condition. ,"Classic environmental triggers for asthma ...
... candidates on Thursday in their first televised debate -- ... Valley , Calif. -- fielded questions about their ... issues, the Washington Post reports. ,The ... Brownback (Kan.); former New York City Mayor Rudolph Giuliani; ...
... More research is needed to determine the true effects ... fetus, and the impact on pregnant women of ... researchers say. ,Recommendations for safe levels ... between states and organisations in Australia, according to new ...
... in health services between rural and metropolitan areas, according ... failure is an increasing public health problem in developed ... of the highest population growths in the over-65 years ... are evident for rural and remote Australians for many ...
... the pollution of the river Yamuna is a major problem. ... days. It was possible some years ago," Indian Space Research ... address at Dayalbagh University here. ,"The prevailing ... hands. I wonder why people are not alarmed and concerned ...
Cached Medicine News:Health News:Poor and Chronically Ill in Korea Pay More for Healthcare 2Health News:Research Demonstrates Link Between Domestic Violence and Asthma 2Health News:Republican Presidential Candidates Discuss Abortion, Stem Cells as Part of First Debate 2Health News:Better Research Needed On Alcohol In Pregnancy 2
... a whole blood control for evaluating the ... measure automated blood cell counts in patient ... RBC and WBC values for the Abbott ... LH750/LH 755 (levels 2 and 3 only) ...
iSleep 20i is an advanced high performance CPAP with outstanding self-adjusting i‑technology....
Spectrum Dynamics empowers Nuclear Imaging with the SmartR Technology,of the D-SPECT Cardiac Imaging System. The D-SPECT is powered by BroadView Technology to provide unprecedented throughput, whil...
Diagnosoft HARP is designed for rapid analysis of tagged cardiac MR images using the HARP technology, which is packaged into an intuitive, easy-to-use graphic user interface....
Medicine Products: