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Patient safety advanced by revised heparin standards
July 31, 2009Continuing to help ensure the identity, purity and quality of heparin, the U.S. Pharmacopeial (USP) Convention has revised written and physical standards for the widely used blood thinner. In February, USP released updated heparin standards at the request of the Food and Drug Administration (FDA) in response to the 2008 public health crisis in which more than 200 people died as a result of heparin adulterated for economic gain. A second phase of revisions is reflected in the newly posted standards. These developments and new information about heparin were discussed by scientists and regulators at the third International Heparin Workshop held at USP headquarters in Rockville, Maryland, July 27󈞈.
"While financially-motivated adulteration of medicines is a distressingly persistent problem," noted Roger L. Williams, M.D., USP's chief executive officer, "I'm pleased at the progress we've made in helping to ensure that such tragic events are minimized. Stronger methods for detecting a range of potential contaminants have been thoroughly assessed and incorporated into the new test methods, and the new physical reference standards are specific to these methods. Manufacturers-and in consequence, physicians and their patients-can feel more confident of the purity and integrity of their heparin products."
The Workshop, co-sponsored by USP, the British National Institute of Biological Standards and Control (NIBSC), and the European Directorate for the Quality of Medicines (EDQM), reflected the global nature of both the problem of adulteration and the resources cooperating to combat it, with attendees from more than 17 countries.
The updated written standards are the Heparin Sodium Stage 2 Monograph and the Heparin Sodium Injection Stage 2 Monograph; new reference standards are Heparin Sodium for Assays, Oversulfated Chondroitin Sulfate, and Dermatan Sulfate. These and other related standards and information are available at http://www.usp.org/hottopics/heparin.html. The new standards will become official on October 1, 2009.
US Pharmacopeia
The updated written standards are the Heparin Sodium Stage 2 Monograph and the Heparin Sodium Injection Stage 2 Monograph; new reference standards are Heparin Sodium for Assays, Oversulfated Chondroitin Sulfate, and Dermatan Sulfate. These and other related standards and information are available at http://www.usp.org/hottopics/heparin.html. The new standards will become official on October 1, 2009.
US Pharmacopeia
Heparin Current Events and Heparin News RSSScientists successfully reprogram blood cells
Researchers have transplanted genetically modified hematopoietic stem cells into mice so that their developing red blood cells produce a critical lysosomal enzyme -preventing or reducing organ and central nervous system damage from the often-fatal genetic disorder Hurler's syndrome.
Investigation of contaminated heparin syringes highlights medication safety issues
An outbreak of bloodstream infections appears to have been caused by the contamination of pre-filled heparin and saline syringes made by a single company.
Drug-eluting stents better than bare-metal stents for heart attack patients
Late-breaking data from the landmark HORIZONS-AMI clinical trial, presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, demonstrated that after two years, in heart attack patients, the use of a drug-eluting stent (paclitaxel) was safer and more effective than a bare-metal stent; and that the administration of the anticoagulant medication bivalirudin enhanced safety and efficacy compared to the use of heparin + GPIIb/IIIa inhibitors.
Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes
Data from a phase II trial of an investigational intravenous drug designed to block the formation of blood clots shows potential to reduce the risk of death, a second heart attack, or other coronary complications compared with the current standard of care in patients presenting with acute coronary syndromes (heart attacks or unstable angina).
'Artificial Golgi' may provide new insight into key cell structure
Scientists in New York and North Carolina are reporting assembly of the first functioning prototype of an artificial Golgi organelle.
Research highlights new approaches to prevent blood clots
Blood clotting, or coagulation, is an important process that prevents excessive bleeding when a blood vessel is injured.
Simple new method detects contaminants in life-saving drug
The blood-thinning drug heparin is highly effective when used to prevent and treat blood clots in veins, arteries and lungs, but earlier this year its reputation as a lifesaver was sullied when contaminated heparin products caused serious allergic reactions that led to a large number of deaths.
HORIZONS AMI will help set guidelines for drug and stent therapy
The HORIZONS AMI clinical trial measuring the safety and efficacy of the use of the medication bivalirudin compared to standard drug therapy - heparin and glycoprotein IIb/IIIa inhibitors -- in heart attack patients who receive angioplasty, found that after 1 year, use of bivalirudin resulted in significantly lower rates of all-cause death, death from cardiac causes, and major bleeding.
Safety of antithrombotic treatment in acute coronary syndromes
The management of acute coronary syndromes (with or without ST segment elevation) requires the use of anticoagulants, antiplatelet agents (aspirin, clopidogrel and/or glycoprotein (GP) IIb/IIIa inhibitors), beta-blockers, thrombolytics in some cases, and revascularization / reperfusion.
Chemists move closer toward developing safer, fully-synthetic form of heparin
Chemists are reporting a major advance toward developing a safer, fully-synthetic version of heparin, the widely used blood thinner now produced from pig intestines. The U. S. Food and Drug Administration last spring linked contaminated batches of the animal-based product, imported from China, to more than 80 deaths and hundreds of allergic reactions among patients exposed to the drug for kidney dialysis and other conditions.
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Monoject Prefill I.V. Syringes - 12mL Syringe, Filled with 5mL 100U/mL Heparin Flush - 180 Per Case - Model SWD590125 by TYCO/KENDALL Saline and heparin flush syringes.Terminally sterile.Drug stopper quality plunger tip.Color-coded.Low breakforce.Latex and perservative free. |
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Fisherbrand Micro Blood Collecting Tubes; Heparin; 100/pack by Fisher Scientific Tubes, capillary blood collection; Fisherbrand; Micro blood collecting tubes; caraway; Heparin; Red tip; 100/pack | |
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Heparin and Related Polysaccharides: Structure and Activities (Annals of the New York Academy of Sciences) by Frederick A. Ofosu (Author), Isidore Danishefsky (Author), Jack Hirsh (Editor) | |
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