News Tagged ‘VA

Surgeons hopeful about new alternatives to heparin

Surgeons are anticipating the approval of new blood thinners that could replace more conventional methods currently in use, according to the Ortho SuperSite, a resource for orthopedic surgeons and rheumatologists.

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FDA clears Baxter in deaths following heparin injections

syringe 100x100Baxter Healthcare Corp. has been cleared by the Food and Drug Administration () in the deaths of two patients at a Delaware hospital following an injection of the drug maker’s heparin. The attributed the two deaths, and the illness of a third patent, to existing medical conditions. All three patients suffered intercranial bleeding following injections of heparin.

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Obama’s pick for FDA commissioner wants to restore trust in agency

President Barack Obama’s top pick for Food and Drug Administration () commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says that she wants to restore public confidence in the , according to Boston.com.

She already has Senator Edward M. Kennedy’s support. “Her expertise is valuable for problems we now face, such as combating food-borne illness, cooperating with other agencies to address the new flu outbreak and drug-resistant diseases, and protecting our food and drug supplies,” Sen. Kennedy said in a statement for the Health, Education, Labor, and Pensions Committee hearing.

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FDA approval for marketing generic Lovenox expected

The expiration of exclusivity period for Sanofi Aventis’ Lovenox has expired, moving Momenta Pharmaceutical Inc. one step closer to gaining approval from the Food and Drug Administration () to manufacture and market is generic Lovenox, M-Enoxaparin, according to Momenta’s first quarter 2009 Earnings Call.

Anticoagulants are often administered to patients before undergoing some surgeries and medical procedures to reduce the risk of life-threatening blood clots. Lovenox has been touted as an effective replacement for the heparin in patients undergoing abdominal surgery.

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Heart device may eliminate need for heparin, warfarin

A small device implanted in the heart to stop blood clots from triggering strokes could serve as an alternative to blood thinners such as heparin and warfarin, according to a new study conducted by the device’s maker, Atritech, Inc. The device, called the Watchman, is designed specifically for patients with atrial fibrillation, a type of irregular heartbeat.

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FDA panel recommends agency approval of heparin alternative

blood cells 100x100A Food and Drug Administration () advisory panel voted last week to recommend agency approval of experimental rivaroxaban, according to Forbes. The medication, made by Johnson & Johnson and Bayer Healthcare Pharmaceuticals, is designed to be used on a short-term basis to prevent pulmonary embolism and deep-vein thrombosis in patients having total knee or hip replacement surgery. Blood clots are common after such surgeries.

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Lawmakers debate safety of importing drugs

Congress continues to debate the notion of allowing people to buy inexpensive drug from other countries, as the Obama administration is encouraging, but the stickler seems to be ensuring the safety of those imported drugs, according to Portfolio.

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New budget supports plan for importation of drugs

obama budget 100x100As a presidential candidate, President Barack Obama said he supported individuals’ rights to import cheaper drugs from other countries provided the beefed up its inspections to ensure the imports are safe. His new budget plan backs up that claim, according to Reuters. The plan, released earlier this week, says it “supports the Food and Drug Administration’s (’s) efforts to allow Americans to buy safe and effective drugs from other countries.”

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Heparin producer’s insurers file lawsuit

The insurance companies for Scientific Protein Laboratories’ parent company, American Capital Ltd., are suing to nullify the policies with the laboratory, according to The Daily Record. The Wisconsin-based company entered a joint venture with Baxter International Inc. to produce heparin in . Last year, heparin produced at that plant was found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a -mimicking material that can cause life-threatening allergic reactions. The contaminated heparin killed more than 80 people in the U.S. and sickened hundreds more before several batches of the were recalled.

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Torti named interim commissioner of FDA

chief scientist and principal deputy commissioner Dr. Frank Torti will serve as the agency’s acting commissioner when Dr. Anderew Von Eschenbach leaves office this week, a position he will hold until the Obama administration appoints a new leader and the Senate approves the choice, according to Scrip World Pharmaceutical News.

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