FDA seizes contaminated lots of blood-thinning drug heparin
ROCKVILLE, Md. The Food and Drug Administration has seized 11 lots of heparin from Cincinnati-based Celsus Labs, the agency announced Thursday.
United States Marshals seized five lots of heparin sodium and six lots of heparin lithium from Celsus at the FDA’s request as part of the agency’s efforts to ensure the safety of the country’s supply of the drug. The 11 lots, manufactured from material imported from China, were found contaminated with over-sulfated chondroitin sulfate, a substance that mimics heparin’s blood-thinning activity.
“This action will help prevent this contaminated heparin from finding its way into the marketplace,” FDA acting associate commissioner for regulatory affairs Mike Chappell said in a statement.
Contamination of injectable heparin products by OSCS has been linked to several adverse drug reactions and deaths, initially reported to the FDA in January. Since then, the agency has conducted comprehensive inspections and imposed import controls to remove OSCS-contaminated heparin products from the market.
AHIMA applauds Barack Obama for campaign success
CHICAGO The American Health Information Management Association has congratulated Barack Obama on his election as president of the United States, calling for reform of the healthcare system.
“Given the president-elect’s strong statements in support of health information as a key to expanding healthcare coverage while improving quality and controlling costs‹most recently during his infomercial last week—AHIMA is understandably optimistic,” AHIMA chief executive officer Linda Kloss said in a statement. “We urge the Obama administration to pursue the imperative of a 21st century health information platform that offers providers, payers and patients the accurate, integrated and secure electronic information they need to make decisions of utmost importance.”
GlaxoSmithKline consolidates U.S. headquarters, announces layoffs of 1,000
PHILADELPHIA GlaxoSmithKline, the maker of Abreva, Aquafresh toothpastes, Nicorette, Sensodyne and Tums will cut its workforce by about 1,800 jobs and make Research Triangle Park in North Carolina its permanent North American headquarters, replacing the current U.S. headquarters in Philadelphia, reports said today.
GlaxoSmithKline has had duel headquarters in the United States since the merger between Glaxo Wellcome and SmithKline Beecham was finalized in 2000, The Wall Street Journal today reported.
Today, GSK said that it will cut 1,800 positions, laying off about 1,000 people and eliminating hundreds of vacant positions, reports said.
GSK’s global headquarters are in London. The company is currently in the midst of belt-tightening in many departments due to growing pressure from the quickly expanding generic drug market and a decline in drug sales.