Posts Tagged ‘Heparin’

Important Changes for Heparin (December 2009)

Tuesday, January 19th, 2010

Video originally created by FDA -- posted by Lawsuit.com on December 14, 2009

FDA is notifying healthcare professionals and patients about a new USP monograph for heparin. Under the new monograph, the reference standard used to determine the potency of the drug will be changed in order to make it compatible with the WHO International Standard. Despite these changes in the reference standard, heparin dosages will continue to be expressed in USP units. Partly in response to the recent heparin contamination problem, the new monograph also includes additional test methods that can detect potential impurities and contaminants.

As a result of the change in the reference standard, the potency of heparin marketed in the U.S. will now be reduced by about 10 percent, so, there could be up to a 10 percent decrease in heparin activity for each USP unit administered. This means that some patients may require more heparin to achieve and maintain the desired level of anticoagulation. Patients may also require more frequent or intensive monitoring of aPTT or ACT.

This could be especially significant in some situations -- for example, when heparin is administered as a bolus IV dose and it is important to achieve an immediate anticoagulant effect. The changes in heparin potency may not be clinically significant when it is given subcutaneously, because the drug’s bioavailability is lower and more variable when it’s administered this way.

Manufacturers began shipping the new heparin product in early October. For a while, both products will be available at the same time, to assure that there is an adequate supply for all patients. FDA has asked the manufacturers to label their heparin to differentiate between the old and new formulations.

FDA is working with heparin manufacturers to study the possible impact of reduced heparin potency on clinical care, and will share the results of these studies when they are available.

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Higher Mortality for Certain Elderly Patients w/ Innohep (March 2009)

Thursday, March 12th, 2009

Video originally created by FDA -- posted by Lawsuit.com on March 10, 2009

Celgene is alerting healthcare professionals of an increased mortality risk among certain elderly patients treated with Innohep (tinzaparin sodium injection). Innohep is a low-molecular weight heparin that is used along with warfarin to treat acute symptomatic deep vein thrombosis with or without pulmonary embolism.

Results of a controlled clinical study conducted in Europe suggest that elderly patients with kidney dysfunction may have a greater risk of death when treated with Innohep than comparable patients treated with unfractionated heparin. In a July 2008 letter, Celgene had highlighted this risk for patients who are 90 years and older, but the company has now changed the labeling to indicate that these risks apply to patients with kidney dysfunction who are 70 and older. The company says to consider alternatives to Innohep when treating these patients.

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More Heparin Dosing Errors with Neonates (Dec. 2008)

Wednesday, December 17th, 2008

Video originally created by FDA -- posted by Lawsuit.com on September 03, 2008

The Institute for Safe Medication Practices (ISMP) reports that serious dosing errors continue to occur when heparin is administered to neonates. ISMP cites an incident in Texas where as many as 17 infants in a neonatal intensive care unit received heparin overdoses. According to ISMP’s analysis, the infants may have received up to 100 times more heparin than intended.ISMP notes that when preparing solutions in the pharmacy, calculation errors are especially prone to occur when heparin is stocked in unfamiliar concentrations e.g., for example, if the pharmacy were to switch from vials containing 1,000 units per mL to vials containing 10,000 units per mL. The possibility of a dosing error increases if the pharmacy fails to verify the concentration of a solution before dispensing.Another problem, according to ISMP, is that there is no standard dosing protocol when it comes to using heparin for maintaining the patency of venous and arterial lines in neonates. This means a hospital might have to stock heparin solutions in several concentrations ranging from 0.5 units per mL to 10 units per mL, and this can make errors more likely.In this report and an earlier one, ISMP offered several suggestions to help avoid these potentially tragic errors. For example, the pharmacy could prepare and dispense heparin flush solutions, rather than having nurses do this in patient care areas. Or a hospital could consider using pre-filled heparin flush syringes, which are now available in several concentrations.ISMP notes that some hospitals use a refractometer to measure the specific gravity of the solutions as they are prepared, and that spectroscopy equipment can also be used to check accuracy. This can differentiate between abnormally high concentrations and the lower concentrations needed for babies. According to ISMP, other hospitals are choosing to outsource the preparation of neonatal heparin flush products, using commercial manufacturers who meet FDA Good Manufacturing Practices and assay their solutions before distribution.

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Heparin Recall Update

Thursday, October 2nd, 2008

Heparin has been an aid used in medicine to treat a variety of aliments for many years. Yet, in 2007, heparin has been related to harm contributing to 62 deaths and hundreds of additional potential legal cases citing death or severe reactions to heparin through contaminated lots produced in Chinese factories  As Doug Monsour, Attorney at Law of  Longview, Texas  explains, “Drugs like heparin do have side effects that can be very harmful to people. The catastrophic injuries that can result from drugs like heparin are devastating.” On June 1, 2008, the number jumped to 86 deaths in the United States associated with Heparin use, according to the FDA’s month-by-month adverse Heparin event reports .-1-The issues surrounding heparin have been linked to one of three manufacturers that produce Heparin- Baxter, International. The drug has been used as an anticoagulant to prevent deep vein thrombosis, pulmonary embolism as well as treat atrial fibrillation, peripheral arterial embolism, and thromboembolic disorder.

Heparin Recall: Prompting Law Suits Due to Anabolic Shock or Severe Allergic Reactions

The Baxter- Heparin recall was fueled in late February 2008 after a St. Louis doctor in January filed a report with the Centers for Disease Control and Prevention mentioning Heparin contamination witnessed in allergic reactions of two children having kidney dialysis. Then there were 448 more reports submitted describing similar allergic reactions in adults on dialysis. The FDA has identified 12 Chinese companies that have produced contaminated Heparin. On January 17, 2008, the FDA and the Chinese authorities finally made inspection of the Changzhou factory in China. This factory began shipping Heparin to Baxter International in 2004 and was never inspected until late February 2008. Inspectors found unclean tanks and untraced raw materials received from mystery vendors, knowing that Heparin is derived from the mucous membranes of the intestines of slaughtered pigs, which often takes place in unsanitary workshops in China. The contamination itself is suspected to originate from a chemically altered form of chondroitin sulfate resulting from unsanitary production conditions. Baxter received over 350 adverse reaction reports from mid December to end of January 2008The adverse reactions of heparin that have been documented include: Severe Nausea, and Vomiting, Abdominal pain, Burning sensation, Chest pain,  Excessive Sweating,  Breathing Difficulty,  Low Blood Pressure,  Death,  Diarrhea, Dizziness, Dyspepsia, Erythema, Flushing, Headache, Hypotension, Increased lacrimation, Loss of consciousness.

Heparin Patient Alert

As Joseph H Saunders, Attorney at Law, of Pinellas Park, Florida explains, “Because heparin is usually prescribed for an emergent condition, the most difficult factor to uncover in lawsuits is the true causation for injury. As personal injury attorneys, we must find anabolic shock or allergic reaction in hospital documentation as we know the contamination led to anabolic shock and allergic reactions.” Heparin is most often taken an emergent basis through injection on or may be less emergency related by month. Should you experience any side effects, your doctor may recommend testing and treatment such as Platelets using Automated Cell Count, Heparin-Induced Thrombocytopenia and Serotonin Release assay.

Inquire with your doctor about the requirement to avoid certain drugs that may increase bleeding such as Naproxin in Aleve, Aspirin and Ibuprophen.

Call your doctor for a new prescription if the medication has changed colors or has any particles in it.

Do not stop using the heparin until your doctor tells you to.

Heparin must not be injected into a muscle.

Use each needle and syringe only one time.

You need to test your blood on a regular basis.

Contact your doctor for instructions if you miss a dose of heparin.

Seek emergency medical attention in case of overdose signified by continuous bleeding, bruising, nosebleeds, or blood in your urine.

Store heparin at room temperature away from heat and moisture.

It is advised that any person receiving heparin seek out the advice of their doctor about continuing the use of heparin and report any adverse reactions immediately to your doctor. Personal injury attorneys that focus on heparin can also assist victims from heparin and can help assess the best means to get the word out about your adverse effect from heparin. Baxter is a trademark of Baxter International Inc. -1- 2-16-08 New York Times Article

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