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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.

Tags: FDA Heparin Baxter International
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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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

Tags: Insulin Heparin Patient Safety FDA Diabetes
CNN's Dr. Sanjay Gupta looks at the FDA's statements that new evidence links China to tainted Heparin.

Tags: Heparin China Drugs poison
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

Tags: Fatal Heparin Overdose FDA Infant Death Patient Safety
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/

Tags: heparin death hospital lawsuit recall grandmother lawyer celldweller1982
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

Tags: Heparin FDA Recall Baxter Lawsuit Lawyer Attorney CDC
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

Tags: Recall Heparin flush syringe saline B. Braun contamination Sierra Pre-filled FDA
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.

Tags: health medicine
I honestly think this is what killed my Mom a year ago. She was taken too soon. I miss her so much and to think, she could possibly still be here watching her grandchildren grow up. This story makes me sick. What kind of heartless person would do this? *I would like to further add......since so many people are getting upset at me and thinking i blame the whole country of China, I do not. I blame Baxter, I blame the FDA, I blame the INDIVIDUAL(S) involved in the tainted Heparin. The United States company, Baxter subcontracted to China, so they are responsible.......NOT CHINA itself. The FDA admits out of over 300 vials of Heparin brought into the USA, they tested 90. That is a shame in itself. So please, people of other countries, do not plaque me with racism, i am not racist at all. I am a well rounded, open minded girl. Thanks for watching my videos :) ~Peace

Tags: heparin drug china communist cnn news death tainted sad mom
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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Joshua Ezrin, an attorney at Audet & Partners, LLP, speaks about the recent Heparin recall.

Tags: heparin recall baxter drug audet attorney class acction
Lecture presented at EISCM congress held in Berlin on October 8th, 2007

Tags: HIT Thrombocytopenia Critical Care Thrombosis
China points the finger at the US. FDA points the finger at China. Wall Street Journal explains how bad heparin has caused adverse health effects, including several deaths.

Tags: heparin drugs contaminated death medicine
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

Tags: Heparin-Induced Thrombocytopenia FDA Pulmonary Embolism Heart Attack Stroke Patient Safety Drug Reaction
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

Tags: ohio medical malpractice nursing home neglect personal injury law firm of elk Heparin Recall
Globalizimi konsiderohet shpesh si një koncept ekonomik. Por ai mund të ndikojë edhe tek shëndeti publik, duke filluar nga lojrat e prodhuara në Kinë, që përmbajnë plumb, e deri tek ushqimet për kafshë, te prodhuara në Kinë, të cilat përmbajnë kimikate të dëmshme. Tani amerikanët po mësojnë se disa nga ilaçet që ata përdorin, prodhohen në Kinë, dhe fatkeqësisht një prej tyre ka shkaktuar probleme

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

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Running Normal Saline versus Heparing

Tags: Med errors
TV advertisement about Heparin Recall from Audet & Partners, LLP

Tags: heparin recall TV ad audet partners llp
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.

Tags: heparin recall baxter's reactions law legal actions baxter induced thrombocytopenia deaths injections overdose problem
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