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Heparin is widely used as an injectable anticoagulant. Pharmaceutical grade heparin is derived from mucosal tissues of slaughtered meat animals, such as pig intestine or cow lung.
Heparin for medical use
Heparin acts as an anticoagulant, preventing the formation of clots and extension of existing clots within the blood. While heparin does not break down clots that have already formed (unlike tissue plasminogen activator), it works to assist the body’s natural clot mechanisms in breaking down clots that have already formed. Heparin is used as an anticoagulant the following conditions:

Acute coronary syndrome, e.g., myocardial infarction
Atrial fibrillation
Deep-vein thrombosis and pulmonary embolism
Cardiopulmonary bypass for heart surgery.

Heparin and its derivatives (enoxaparin, dalteparin, and so forth) are effective at preventing deep-vein thromboses and pulmonary emboli in patients at risk,[1][2] but there is no evidence that they are effective at preventing death.[3] Current guidelines recommend aspirin and leg stockings instead.[4]

^Enoxaparin plus compression stockings compared with compression stockings alone in the prevention of venous thromboembolism after elective neurosurgery
^Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer
^Heparin, low molecular weight heparin and physical methods for preventing deep vein thrombosis and pulmonary embolism following surgery for hip fractures
^Prophylaxis of venous thromboembolism

Tainted lots of heparin recalled

Certain lots of the blood thinner heparin are being recalled because testing revealed that the drug is contaminated with trace amounts of oversulfated chondroitin sulfate (OSCS). The recall includes seven lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun Medical Inc. that were manufactured in 2008 and expire on October 31, 2010 and November 30, 2010. Heparin is a widely used blood thinner used to treat and prevent blood clots. In March 2008, major recalls of heparin were announced due to severe adverse reactions and deaths from lots manufactured in a China facility that a Food ... Read More

Baxter faces numerous lawsuits over tainted heparin scandal

As many as 300 product-liability lawsuits may be filed in the Illinois state court against drug maker Baxter International Inc., by people injured by or families who lost loved ones to contaminated batches of the blood thinner heparin. Per a judge’s order last year, attorneys are working to convert an aggregate lawsuit to individual claims against the Deerfield, Illinois-based drug company. The complaints accuse Baxter and its supplier, Scientific Protein Laboratories LLC, of negligence, alleging Baxter’s heparin was unsafe for the intended use. The lawsuits seek money damages. The nightmare began in late 2007, as reports of serious allergic reactions ... Read More

Revised boxed warning placed on blood thinners

A group of blood thinners used to reduce the risk of deep vein blood clots in patients has updated their products’ safety labeling and revised the boxed warning to include a risk of epidural or spinal hemotomas in some patients, according to an announcement by the Food and Drug Administration (FDA). The FDA places boxed warnings, also known as black box warnings, on drugs that, based on medical studies, carry a significant risk of serious adverse side effects or death. The blood thinners included in this announcement include Arixtra (fondaparinux sodium) Solution for subcutaneous injection; Fragmin (dalteparin sodium injection) for ... Read More

FDA notifies public about changes to heparin potency

The blood thinner heparin will now include a new reference standard and test method that is used to determine the potency of the drug and detect impurities that may be present in it, according to a safety alert issued by the Food and Drug Administration (FDA). The change is effective as of October 1, 2009, and will harmonize the USP unit dose with the WHO International Standard unit does, which will result in an approximately 10 percent reduction in the potency of the heparin marketed in the United States. The alert was issued to pharmacists, physicians, hospital risk managers and ... Read More

USP updates standards for heparin

A recent report in Huliq News documents efforts by the U.S. Pharmacopeial (USP) Convention to improve the safety of blood thinner heparin by revising its written and physical standards for the drug. The update comes at the request of the U.S. Food & Drug Administration (FDA) following a 2008 public health crisis when more than 200 people died after being administered contaminated heparin. According to its web site, U.S. Pharmacopeia is an official public standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured in the United States. It is a non-governmental, not-for-profit public health organziation ... Read More

Four lawsuits filed in contaminated heparin case

Four lawsuits were filed last month in Cook County, Illinois court against the makers of the blood thinner heparin, claiming the product the company manufactured was contaminated and caused patients to die. Named in the lawsuit are Baxter International, Baxter Healthcare Corporation and Scientific Protein Laboratories. Both Baxter International and Baxter Healthcare have been sued 24 times in 2009 alleging the drug maker’s heparin was contaminated and led to death or serious injury. In February 2008, the Food and Drug Administration (FDA) ordered a recall of nine lots of Baxter’s heparin manufactured in the company’s China plant after more than ... Read More

Heparin alternative Angiomax granted pediatric exclusivity

The Food and Drug Administration (FDA) has granted pediatric exclusivity to The Medicines Company for its anticoagulant Angiomax. The approval is based on studies submitted in response to a Written Request by the FDA to investigate the use of Angiomax in pediatric patients aged birth to 16 years. “The FDA’s decision responds to the critical need for effective anticoagulant treatments for children undergoing intravascular heart procedures,” said Rolando Zamora, MD, Director of Pediatric Interventional Cardiology, Methodist Children’s Heart Institute, San Antonio, TX. “There have been very few studies of anticoagulation in children, especially in those undergoing these critical heart procedures, ... Read More

Watchdog group pressures FDA about contaminated syringes

Watchdog group Project on Government Oversight (POGO) is asking the Food and Drug Administration (FDA) inspector general to investigate why the agency failed to stop contaminated syringes from reaching the public that caused four deaths and 162 serious injuries to individuals who were treated with the tainted products. POGO is an independent nonprofit group that investigates and exposes corruption and other misconduct in order to achieve a more effective, accountable, open and ethical federal government. The organization has spoken out previously about the FDA and its handling of contaminated food and drugs, such as the tainted heparin scandal of 2007. ... Read More

FDA should have acted faster to prevent contamination

Leslie Fullerton provided the best care he could for his 29-month-old daughter Natalie with the medical equipment and medications provided him, but he still blames himself for her death. The little girl had already undergone a double-lung transplant and was recovering nicely when her father, following instructions of his daughter’s health care provider, used a pre-filled syringe to clean the tube implanted in Natalie’s chest to give her intravenous medication. Days later, Natalie became breathless and feverish as a bacteria infected her blood. Months later, Natalie died. Investigators now know that the pre-filled heparin and saline syringe Fullerton used was ... Read More

China says tainted drug blame should fall on foreign suppliers

A Chinese senior health official says China has been unfairly labeled as a center for fake drug production and that blame should be placed instead on foreign companies who do business with unregistered firms against Chinese regulations. Bian Zhenijia, director of the drug safety supervision department of the State Food and Drug Administration (SFDA), urged companies to be more responsible when dealing with foreign suppliers. “The problem lies in the fact that some overseas companies have an implicit deal with underground factories or illegal manufacturers in China, so the product involved has problems,” Bian said at a press conference. China’s ... Read More