News for February, 2009

New budget supports plan for importation of drugs

obama budget 100x100As a presidential candidate, President Barack Obama said he supported individuals’ rights to import cheaper drugs from other countries provided the beefed up its inspections to ensure the imports are safe. His new budget plan backs up that claim, according to Reuters. The plan, released earlier this week, says it “supports the Food and Drug Administration’s (’s) efforts to allow Americans to buy safe and effective drugs from other countries.”

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FDA knew of tainted syringes two years before inspecting plant

The received reports of about debris in syringes filled with heparin and saline distributed by AM2PAT as early as 2005, yet the agency didn’t follow up on those complaints until 2007, after five deaths and hundreds of illnesses were linked to the contaminated syringes, according to the Associated Press.

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Two sentenced for role in tainted heparin, saline syringes

syringe 100x100In an effort to ship heparin- and saline-filled syringes faster, workers at a facility in North Carolina failed to check sterility and then falsified manufacturing dates to make it appear those safeguards were followed, according to an Associated Press report. Those syringes, as it turned out, were tainted with a bacteria known as Serratia marcescens and may have lead to five deaths and hundreds of infections in those who received them.

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Baxter named in contaminated saline syringe lawsuit

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.

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Scientists propose new testing standards for heparin

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 were later found to have been contaminated with oversulfated chondroitin sulfate (OSCS) during manufacturing at Baxter International’s plant. OSCS is a -mimicking contaminant that can cause serious allergic reactions in humans.

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Heparin producer’s insurers file lawsuit

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 . Last year, heparin produced at that plant was found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a -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 were recalled.

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