Two infants died with large amounts of Hepairn found in their blood. Hospital officials are linking it to a mixing error. Maggie Rodriguez speaks to the grandparents of the children.

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Apr 22 - The FDA was in the hot seat on Capitol Hill after a tainted drug was implicated in multiple deaths.A recent study found that more than 80 percent of active ingredients in U.S. drugs come from abroad, but only 11 percent of foreign suppliers are investigated by the FDA.Deborah Lutterbeck reports.

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Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recommendations on this continuing issue. Heparin is an anticoagulant commonly used subcutaneously and intravenously in patients undergoing kidney dialysis, certain types of cardiac surgery and other procedures. It is also used in lock flush solutions to maintain the patency of IV catheters, and as a coating or ingredient in certain medical devices and diagnostic products. Towards the end of 2007, FDA started receiving an increasing number of reports of adverse events associated with injectable heparin products, especially when the heparin was administered as a bolus dose. Many of these events were consistent with either an anaphylactic-type reaction or acute hypotension. A small number of similar events have also been reported for heparin flush solutions. FDA has identified a contaminant in the heparin, an oversulfated chondroitin sulfate, that may have led to the adverse events. This contaminant mimics heparin activity so closely that routine testing did not uncover it. Special test methods are needed to detect this contaminant, and the major U.S. heparin manufacturers and suppliers have agreed to perform these tests to screen all heparin active ingredient that they receive. FDA has also asked medical device companies to identify any product they market that contains heparin or uses heparin in processing. A number of companies have recalled heparin or products containing heparin. They did this based either on reports of adverse events or as a precaution after the special testing revealed that the company had been supplied with contaminated lots of heparin. FDA is asking healthcare professionals and facilities to take the following steps: • Report adverse reactions associated with any drug or device that contains heparin. FDA is continuing to actively monitor this situation and it is essential that new events are reported as soon as possible. FDA is focusing on events involving injectable heparin, heparin lock flush solutions or medical devices that contain heparin. That could include certain blood collection tubes, intravascular catheters, vascular stents and grafts, and other devices used during cardiac procedures, such as oxygenators, pumps, filters and blood reservoirs. • Pay attention to recalls of heparin or heparin-containing products, including those by Baxter Healthcare, American Health Packaging, B. Braun, Covidien, Medtronic and Atrium Medical. • Check all drug and device storage areas, including emergency kits, crash carts, dialysis units and automated drug storage cabinets, to make sure that all recalled heparin products have been removed and are no longer available for use. The investigation of contaminated heparin is still underway. The links (see "Additional Information" below) will be updated with the latest information as it becomes available.

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FDA is alerting healthcare professionals that the onset of heparin-induced thrombocytopenia (HIT) can be delayed in patients who had previously been treated with heparin sodium injection. HIT results from an irreversible aggregation of platelets. About half the time, it can lead to development of venous and arterial thromboses, a condition called heparin-induced thrombocytopenia and thrombosis (HITT). If this occurs, serious thrombotic complications can include pulmonary embolism, stroke, MI, skin necrosis, gangrene and even death. New warnings in the drug label point out that HIT, with or without thrombosis, can occur up to several weeks after heparin therapy is stopped. So patients who present with thrombocytopenia or thrombosis after they discontinue heparin should be evaluated for HIT and HITT. Heparin should not be administered to these patients until their platelet count is checked, because giving heparin to these patients could cause serious or even fatal reactions. Additional Information: FDA MedWatch Safety Alert. Heparin Sodium Injection. December 8, 2006. http://www.fda.gov/medwatch/safety/2006/safety06.htm#Heparin

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Heparin Lawsuit Areas of Inquiry discussed, including time frame for contamination of Heparin, forensic and pathological investigations, issues, with respect to permanent damage in survivors. Attorney Gordon Johnson http://heparin-law.com 800-992-9447

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Here is an alert about a nationwide recall of all heparin and normal saline flushes manufactured by AM2 PAT, Inc. These pre-filled syringes are distributed under two brand names: Sierra Pre-filled and B. Braun. Some of the syringes have been found to be contaminated with Serratia marcescens, which has caused patient infections that can be serious and even fatal. All sizes and strengths of these heparin and saline flushes are being recalled. If you have any of these syringes, stop using them immediately. Quarantine them and return them to your distributor. For questions, contact the company at 919-552-9689. FDA Patient Safety News: March 2008 For more information, please see our website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=73#2

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my grandmother fell and broke her hip on the 14 of april and was in the hospital 3 days and died..... she was administered heparin, a type of blood thinner than is used to prevent blood clots. we think this killed her.... there is an ongoing class action lawsuit going on and i contacted a lawyer last night... info; http://www.heparin-law.com/

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Recently there have been four deaths and 350 significant allergic reactions to Heparin made by the Baxter Brand. For Baxter, a key ingredient for Heparin is being made in China that has been linked to the adverse reactions.

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How do you manage a elderly person with Myocardial infarction ?

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Video provides information on recalled Heparin. There have been multiple Heparin recalls issued by a large number of manufacturers due to the chance that their products may contain contaminated Heparin. Learn more about the Heparin recall by visiting our website: http://www.injuryhelpnetwork.com

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The New Jersey Department of Health and the Institute for Safe Medication Practices (ISMP) have each recently warned about several different ways that dangerous mix-ups can occur between insulin and heparin. Some of these mix-ups happened when patients receiving total parenteral nutrition had insulin added to their TPN bags instead of heparin. In one case, a premature infant in the NICU had a blood glucose level of 17 mg/mL several hours after being started on a TPN infusion. Despite multiple administrations of dextrose, the hypoglycemia did not completely resolve until TPN was stopped. A later analysis showed that the fluid contained insulin, not heparin. This infant's long term outcome has not yet been determined, and ISMP describes two similar incidents where the babies died. These kinds of errors can happen other ways. For example, two patients who were not diabetic died after being injected with insulin instead of heparin during a vascular catheter flush procedure. In a different case, a nurse erroneously transcribed a verbal order to resume an insulin drip as "resume heparin drip." And in yet another case, a pharmacist entered an order for heparin 500 units into the computer as "regular insulin 500 units." ISMP says several factors contribute to these mix-ups. First, the 10 mL vials of insulin and heparin often look similar. Both insulin and heparin are typically used every day during each shift, so these similar-looking vials are often next to each other on a counter, a drug cart, or under a pharmacy IV admixture hood. Both drugs are dosed in units. And ISMP says that as insulin infusions become more common, the risk of a mix-up may be growing. The New Jersey Department of Health and ISMP recommend a number of strategies to reduce the risk of these kinds of mix-ups. Here are some of them: • Do not keep insulin and heparin vials next to each other. • To avoid using vials that look alike, consider using heparin bags of 100 units/mL. Heparin prefilled syringes could be used for admixtures. And consider providing insulin to patient care units in pen devices rather than vials. • Require independent double-checks of IV insulin and IV heparin doses and infusions, and also an independent double-check through each step of preparing TPN solutions. • Write verbal orders directly on order forms and then verify the accuracy by reading back the order. • Finally, when a patient develops unexpected, unexplained hypoglycemia, consider the possibility that a medication error may have occurred and take the following steps: discontinue all current infusions and hang new solutions, treat the patient as necessary with dextrose, and check for unintended additives by sending the infusion bag(s) for analysis. Additional Information: ISMP Medication Safety Alert! Action needed to prevent dangerous heparin-insulin confusion. May 3, 2007. http://www.ismp.org/Newsletters/acutecare/articles/20070503.asp

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Heparin 23.05.2007

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http://www.medpagetoday.com ROCKVILLE, Md. -- The FDA said today that a heparin-like contaminant found in heparin and linked to several deaths has been identified in crude lots of the drug at a Chinese processing plant.

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Continuing with anticoagulants.

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when i was at the hospital they inserted a really long and big needle into me and just taped it there.. its called a heparin lock.. its where they inject dye into my veins for my ct scan.. hurt like hell

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Fox Business Happy Hour - Jeremy Discusses how America's lead over China in science, medicine and industry translates into valuable opportunities for American Business

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Joshua Ezrin, an attorney at Audet & Partners, LLP, speaks about the recent Heparin recall.

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Dr Deutsch Reports on the FDA recall of Contaminated Heparin which is linked to 80 deaths in the US

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The Institute for Safe Medication Practices recently cited a case in which three premature infants died after receiving an overdose of heparin. According to ISMP, this may have occurred because heparin vials containing 10,000 units/mL were placed in an automated dispensing cabinet where vials containing 10 units of heparin per ml were normally kept. The vials looked somewhat similar, and the nurses did not notice that the ones that were taken from the cabinet actually contained 10,000 times more heparin than they expected. ISMP notes that errors in filling automated dispensing cabinets are common, and so it is important to double-check the contents of these cabinets before they leave the pharmacy. The ISMP Alert lists several other steps to help prevent these kinds of errors. For example: • Consider which medications might be removed from automated dispensing cabinets for safety's sake, especially in those cabinets that are used for high-risk patients such as neonates and children. • Take steps to minimize look-alike packages and labels. When possible, do not stock items on nursing units that require further preparation before administration. • Consider bar coding for medication administration management systems throughout the hospital, if not already in place. Even if bedside scanning is not being used, dispensing cabinet vendors provide bar code systems to make sure the right medications are stocked in these cabinets. Additional Information: ISMP Medication Safety Alert! Infant Heparin Flush Overdose. September 21, 2006. http://www.ismp.org/Newsletters/acutecare/articles/20060921a.asp

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Lecture presented at EISCM congress held in Berlin on October 8th, 2007

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Heparin sodium, a blood thinner used in patients undergoing surgery & dialysis, was recalled due to an increased number of reports of serious side effects including low blood pressure / hypotension, refractory hypotension, blood clots, stroke, death.

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Individuals who may have used lot #070926H of the Sierra pre-filled heparin flush should immediately stop using the flush and contact their healthcare provider for a replacement supply and seek immediate medical attention if they develop a fever or other signs of an infection. If you have any questions please call the Law Firm of Elk and Elk at 1 800 ELK OHIO http://www.baxter-heparin-recall.com/ http://www.medical-malpractice-ohio.com/ http://www.elkandelk.com/index.shtml

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TV advertisement about Heparin Recall from Audet & Partners, LLP

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Here is an alert about a nationwide recall of all heparin and normal saline flushes manufactured by AM2 PAT, Inc. These pre-filled syringes are distributed under two brand names: Sierra Pre-filled and B. Braun. Some of the syringes have been found to be contaminated with Serratia marcescens, which has caused patient infections that can be serious and even fatal. All sizes and strengths of these heparin and saline flushes are being recalled. If you have any of these syringes, stop using them immediately. Quarantine them and return them to your distributor. For questions, contact the company at 919-552-9689.

Tags: Heparin Saline Flush Syringes Sierra Pre-Filled B. Braun Recall FDA

Heparin sodium recalled due to serious side effects (low blood pressure or hypotension, refractory hypotension, blood clots, stroke & death). Prefilled heparin & saline flush syringes recalled due to bacteria contamination causing infections.

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