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Vystar(R) Corporation And Alatech Healthcare, LLC Announce FDA 510(k) Clearance For Exam Gloves Made With Vytex(R) NRL
Vystar Corporation and Alatech Healthcare, LLC announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and sell the first exam gloves manufactured with Vytex® Natural Rubber Latex (NRL). Alatech plans to introduce exam gloves made with Vytex NRL in the near future.
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Plan To Reduce Red Tape Will Benefit Patients, Australia
Draft proposals by the Productivity Commission designed to reduce the red tape burden on medical practices will benefit patients, the AMA said today.
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Payment Reform: A Trend In White House Thinking
White House health reformers have pressed over the last month for payment reforms that would reward doctors and hospitals for spending less and delivering higher quality care, rather than simply providing a higher volume of services. The Wall Street Journal reports that reexamining payment systems is a hot topic among administration officials in other disciplines, too: "President Barack Obama believes you get what you pay for--in business, in health care and in teaching. And in each of those spheres, he doesn"t think the way the U.S. pays professionals is designed to get what the nation really wants and needs."
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FDA Approves Effient To Reduce The Risk Of Heart Attack In Angioplasty Patients

The U.S. Food and Drug Administration has approved the blood-thinning drug Effient tablets (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery. During an angioplasty, a balloon is used to open the artery that has been narrowed by atherosclerotic plaque.Often, a tiny wire mesh scaffold (stent) is inserted into the blood vessel to help keep the artery open after the procedure. Platelets in the blood can clump around the procedure site, causing clots that can lead to heart attack, stroke, and death. Effient was studied in a 13,608-patient trial comparing it to the blood-thinning drug, Plavix (clopidogrel), in patients with a threatened heart attack or an actual heart attack who were about to undergo angioplasty. The fraction of patients who had subsequent non-fatal heart attacks was reduced from 9.1 percent in patients who received Plavix to 7.0 percent in patients who received Effient.While the numbers of deaths and strokes were similar with both drugs, patients with a history of stroke were more likely to have another stroke while taking Effient. In addition, there was a greater risk of significant, sometimes fatal bleeding seen in patients who took Effient. "Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure," said John Jenkins, M.D., director of the Office of New Drugs, in the FDA"s Center for Drug Evaluation and Research."Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug." The drug"s labeling will include a boxed warning alerting physicians that the drug can cause significant, sometimes fatal, bleeding. The drug should not be used in patients with active pathological bleeding, a history of mini-strokes (transient ischemic attacks) or stroke, or urgent need for surgery, including coronary artery bypass graft surgery. Effient is manufactured by Eli Lilly and Company of Indianapolis, in partnership with Tokyo-based Daiichi Sankyo Ltd. U.S. Food and Drug Administration


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