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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.
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.
Congress continues to debate the notion of allowing people to buy inexpensive drug from other countries, as the Obama administration is encouraging, but the stickler seems to be ensuring the safety of those imported drugs, according to Portfolio.
A class action lawsuit has been filed against Baxter claiming the drug maker substituted an ingredient in its blood thinner heparin with a cheaper, more dangerous one in order to reap more profits, according to the Madison-St. Clair The Record. Twenty-eight people are named in the lawsuit, most of whom are spouses of individuals who died after receiving injections of the tainted heparin. The lawsuit was filed in St. Clair County Court in Illinois.
Pharmaceutical giant Baxter International faces yet another lawsuit, this time for playing a role in the distribution of a contaminated saline syringe that was used on a woman who afterward suffered serious medical problems that may have led to her death a year later, according to the Hays Daily News.
Scientists are proposing new standards for testing the quality and safety of heparin with new equipment that can analyze a broader range of impurities than the screening tools currently in use, according to the Daily Herald. The proposal stems from last year’s tainted heparin scandal that resulted in the deaths of more than 80 Americans and illness in hundreds more. Batches of heparin were later found to have been contaminated with oversulfated chondroitin sulfate (OSCS) during manufacturing at Baxter International’s China plant. OSCS is a heparin-mimicking contaminant that can cause serious allergic reactions in humans.
The insurance companies for Scientific Protein Laboratories’ parent company, American Capital Ltd., are suing to nullify the policies with the laboratory, according to The Daily Record. The Wisconsin-based company entered a joint venture with Baxter International Inc. to produce heparin in China. Last year, heparin produced at that plant was found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a heparin-mimicking material that can cause life-threatening allergic reactions. The contaminated heparin killed more than 80 people in the U.S. and sickened hundreds more before several batches of the blood thinner were recalled.
Lawmakers’ concern over the U.S. becoming too reliant on foreign countries to produce drugs are calling for a rule to require certain drugs to be made or stockpiled in the U.S., according to the New York Times. The Times quotes Sen. Sherrod Brown of Ohio as saying that relying on other countries to produce our country’s medicines opens the door to “supply disruptions, counterfeit medicines, even bio-terrorism.”
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