News Tagged ‘IC

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.

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China says tainted drug blame should fall on foreign suppliers

china flag1 100x100A 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.

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Surgeons hopeful about new alternatives to heparin

Surgeons are anticipating the approval of new blood thinners that could replace more conventional methods currently in use, according to the Ortho SuperSite, a resource for orthopedic surgeons and rheumatologists.

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FDA clears Baxter in deaths following heparin injections

Baxter Healthcare Corp. has been cleared by the Food and Drug Administration (FDA) in the deaths of two patients at a Delaware hospital following an injection of the drug maker’s blood thinner heparin. The FDA attributed the two deaths, and the illness of a third patent, to existing medical conditions. All three patients suffered intercranial bleeding following injections of heparin.

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Baxter says it’s not responsible for recent heparin deaths, illness

It’s like a bad dream happening all over again – people falling ill or dying after receiving doses of the blood thinner heparin. In 2007, tainted doses of heparin killed more than 80 Americans and injured hundreds more. And while investigations into the cause continue, the culprit was found to have been over-sulfated chondroitin sulfate (OSCS) a -mimicking contaminant that made its way into batches of that were manufactured in ’s China plant.

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New deaths, illness following heparin use spark FDA investigation

The Food and Drug Administration (FDA) is testing batches of the blood thinner heparin after two people died and one became ill after receiving doses of the heparin, according to the Wall Street Journal.

All three incidences occurred at the Beebe Medical Center in Lewes, Delaware, and all three were given supplied by Baxter, the same drug company at the center of last year’s contaminated heparin scandal. That , which killed more than 80 people and injured hundreds more, was manufactured in China. The latest batch was manufactured in Ohio.

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Obama’s pick for FDA commissioner wants to restore trust in agency

President Barack ’s top pick for Food and Drug Administration (FDA) commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says that she wants to restore public confidence in the FDA, according to Boston.com.

She already has Senator Edward M. Kennedy’s support. “Her expertise is valuable for problems we now face, such as combating food-borne illness, cooperating with other agencies to address the new flu outbreak and drug-resistant diseases, and protecting our food and drug supplies,” Sen. Kennedy said in a statement for the Health, Education, Labor, and Pensions Committee hearing.

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FDA approval for marketing generic Lovenox expected

The expiration of exclusivity period for Sanofi Aventis’ blood thinner has expired, moving Momenta Pharmaceutical Inc. one step closer to gaining approval from the Food and Drug Administration (FDA) to manufacture and market is generic , M-Enoxaparin, according to Momenta’s first quarter 2009 Earnings Call.

Anticoagulants are often administered to patients before undergoing some surgeries and medical procedures to reduce the risk of life-threatening blood clots. has been touted as an effective replacement for the blood thinner heparin in patients undergoing abdominal surgery.

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Congressman demands answers on tainted heparin scandal

rep joe barton 100x100 of Texas wants the Food and Drug Administration (FDA) to turn over databases stemming from last year’s tainted heparin scandal that killed more than 80 Americans and injured hundreds more, according to NASDAQ.com. At a public hearing last week, Barton raised concerns that the agency doesn’t know for sure what caused the contamination.

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FDA accuses Chinese companies of lying about role in heparin scandal

The Food and Drug Administrating (FDA) is accusing two Chinese pharmaceutical manufacturing companies of lying to federal regulators about their role in shipping batches of contaminated heparin into the United States between 2007 and 2008, according to Easy Bourse.

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