Vidyya Medical News Service
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Volume 6 Issue 321 Published - 14:00 UTC 08:00 EST 16-Nov-2004 Next Update - 14:00 UTC 08:00 EST 17-Nov-2004
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FDA to announce important labeling changes for mifepristone
The Food and Drug Administration will announce today important new safety changes to the Danco Laboratories, LLC's labeling of mifepristone (trade name Mifeprex, also known as RU-486). Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less. FDA and Danco Laboratories have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, including another death from sepsis that was recently reported to FDA. These reports have led to the revision of the black box labeling.  more

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Information for patients: Mifepristone questions and answers
FDA has been informed of additional postmarketing adverse events in the United States involving cases of bacterial infection in women following the use of Mifeprex and misoprostol for medical abortion. Overwhelming bacterial infection (septic shock) has led to death.  more

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Study clarifies impact of age on safety of warfarin treatment for atrial fibrillation
A study conducted at Massachusetts General Hospital (MGH) has clarified the risk of intracranial hemorrhage in older patients with atrial fibrillation who take the drug warfarin to prevent ischemic stroke. The report in the November 16 Annals of Internal Medicine showed that treatment at moderate levels of intensity has no greater risk of hemorrhage than does lower intensity treatment. Although the risk of hemorrhage did significantly increase in patients over 85, that risk often can be minimized by tight control of warfarin intensity. more

 


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Proposed addiction treatment successful, safe in second small trial
A second, small-scale clinical trial of a proposed addiction treatment originally investigated at the U.S. Department of Energy’s Brookhaven National Laboratory has produced favorable results in the treatment of long-term addiction to methamphetamine and/or cocaine, with no visual side effects in any of the 30 patients enrolled.  more

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Information for patients: GVG -- A promising strategy for treating addiction
GVG, or gamma vinyl-GABA, appears to prevent the biochemical and behavioral effects of nicotine and cocaine in much the same way it prevents an epileptic seizure: by altering the way brain cells talk to one another.  more

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Nuclear imaging offers possibility for early detection of patients with coronary heart disease
Nuclear imaging will play an increasing role in both the detection of atherosclerosis (coronary heart disease) and, more specifically, the composition of plaque build up that can block the flow of blood through an artery, according to journal reports published by the Society of Nuclear Medicine.  more

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New study shows patients experience asthma variability, despite strict adherence to guidelines
A study presented today at the 62nd Annual Meeting of the American College of Allergy, Asthma and Immunology shows that many patients with asthma continue to experience variability of disease control, despite strict adherence to treatment guidelines published by the National Heart, Lung and Blood Institute. more

 
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