Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The sole provider of heparin in the United States, APP Pharmaceuticals LLC, has launched a Web site as a first step toward improving the safety of the medications it sells in the U.S., according to Reuters.

The Web site details the safety measures the pharmaceutical company has taken over the past several months, including enhanced labeling, unit-of-use bar codes, large lettering and color-coded bottle stoppers to help eliminate misuse of its products, which also includes injectible drugs for oncology.

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President-elect Barack Obama has made no formal announcement as yet, but it appears likely that Sen. Tom Daschle will be appointed Obama’s choice for Health and Human Services secretary, according to The Federal Times.

If so, Dashle will inherit a department that oversees the FDA, an agency that is rife with issues. The agency has been the subject of criticism over its handling of the tainted heparin scandal earlier this year in which more than 80 Americans were killed and hundreds more sickened after receiving injections of heparin from China.

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Clinical tests conducted by the Journal of the American Medical Association comparing brand and generic cardiovascular drugs show that generic drugs are bio-equivalent to the drugs they are patterned after. And, the FDA adds, generics are far less expensive than brand-name drugs. However, U.S. News & World Report raises questions about the quality of the generic drugs.

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The FDA announced this week that it has received information about the Innohep in Renal Insufficiency Study (IRIS) that was stopped in February because of an interim finding of increased all-cause mortality in patients who received Innohep. Innohep contains tinzaparin sodium, a low molecular weight heparin that is given to patients in conjunction with warfarin sodium intravenously to treat blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs (pulmonary embolism).

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A team of researchers from the Massachusetts Institute of Technology (MIT) has confirmed that over-sulfated chondroitin sulfate was, in fact, the contaminant in heparin that was manufactured in China and triggered serious allergic reactions that caused more than 80 Americans to die and hundreds more to be sickened earlier this year, according to ABC Action News.

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