Aren't we happy the Bush administration's regulatory agencies are toothless fuzzballs? I mean, everyone knows how to get replacement livers on the black market, don't they?
Review of Sanofi Drug Is Sought - WSJ.com : An antibiotic from Sanofi-Aventis SA that has been linked to rare reports of severe liver problems -- including several deaths -- will be subjected to new scrutiny by federal health advisers, according to a document released Tuesday.The Food and Drug Administration has asked a joint panel of outside experts to discuss the overall risks and benefits of the French drug maker's Ketek antibiotic during a Dec. 14-15 meeting, according to a federal notice.
The announcement comes as the Senate Finance Committee investigates allegations of fraud connected with trials of Ketek, as well as how the FDA has handled safety issues associated with the drug. The joint panel's two-day review of Ketek could lead to a recommendation that the agency add further warnings to the drug's label or take other action.
Ketek, also called telithromycin, already carries a bold-type warning about the rare reports of liver failure and severe injury, some of them fatal, in patients treated with the drug. The FDA approved Ketek in 2004. The drug is used to treat respiratory-tract infections, bronchitis, sinusitis and community-acquired pneumonia.
Through April, the FDA received at least a dozen reports of acute liver failure, including four deaths, among people treated with Ketek. The FDA also knows of at least 23 other cases where patients suffered serious liver injuries after receiving the antibiotic.
The FDA, in previously disclosed documents, has said the rate appeared higher in comparison with similar antibiotics
Wonder how Michael Moore's movie is coming along?
Technorati Tags: ethics, FDA, Pharmaceuticals
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Sinusitis is an inflammation of the mucus membranes or lining of the Para nasal sinuses. Acute sinusitis is common and is often associated with a viral or bacterial nasal infection that spreads to the sinuses. When the sinuses become blocked, they become filled with fluid producing pain and pressure. Other symptoms of sinusitis are fever, fatigue, and postnasal drainage.
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