› $4.85 Billion settlement in drug case
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.
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.
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.
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.
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 heparin-mimicking contaminant that made its way into batches of heparin that were manufactured in Baxter International’s China plant.
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 heparin supplied by Baxter, the same drug company at the center of last year’s contaminated heparin scandal. That heparin, which killed more than 80 people and injured hundreds more, was manufactured in China. The latest batch was manufactured in Ohio.
Rep. Joe Barton 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.
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.
The Food and Drug Administration (FDA) announced this week safety labeling changes on the blood thinner heparin to include warnings of fatal medication errors that have resulted in heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT), in particular in neonates, or infants less than a year old.
A Food and Drug Administration (FDA) advisory panel voted last week to recommend agency approval of experimental blood thinner rivaroxaban, according to Forbes. The medication, made by Johnson & Johnson and Bayer Healthcare Pharmaceuticals, is designed to be used on a short-term basis to prevent pulmonary embolism and deep-vein thrombosis in patients having total knee or hip replacement surgery. Blood clots are common after such surgeries.
