Buy this domain.

free-best-hosting.com

J&J Blood Thinner Should be Approved, FDA Panel Says | 24-7-news.com cialis online

J&J Blood Thinner Should be Approved, FDA Panel Says

AddThis Social Bookmark Button

Earlier this week, U.S. Food and Drug Administration (FDA) staffers criticized a proposed new blood thinner called rivaroxaban, according to a Dow Jones report.  Now, says HealthDay News, the FDA’s advisory panel found that rivaroxaban’s benefits outweigh its risks, opening the door for FDA approval of the controversial drug.

Proponents of rivaroxaban claim it offers blood-clotting benefits over the more commonly used blood thinner, Heparin, said HealthDay News.  Heparin is typically used in hospital environments because it’s easier to monitor than Coumadin (generic:  warfarin), which—said HealthDay News—requires ongoing blood tests to manage blood levels; rivaroxaban is administered as a once-a-day pill.

According to an earlier report by Reuters, FDA staff found that bleeding, cardiovascular events, and potential liver injury were linked to the anti-coagulant; its brand-name European version—Xarelto was found to cause bleeding “in significantly more patients” than enoxaparin, the current treatment used in the U.S. Enoxaparin is sold by Sanofi-Aventis SA under the brand name Lovenox. The clinical review stated that long-term safety data is needed to adequately evaluate rivaroxaban’s liver damage potential, said Reuters, which results from an increase in a liver enzyme that is indicative of liver damage, said Dow Jones.

Data submitted to the FDA concerning the drug included four major clinical studies involving over 12,000 patients, said Dow Jones; the studies typically compared rivaroxaban to enoxaparin and revealed that bleeding which required medical intercession, while low, occurred at twice the rate as enoxaparin, a significant finding. The FDA found that in addition to bleeding risks being higher in the rivaroxaban group over the enoxaparin group, two rivaroxaban patients died of a fatal bleed during the clinical trial, said Dow Jones this week. There were no deaths in the enoxaparin group.

The anti-coagulant rivaroxaban was created to prevent blood clots from forming and, while better than some of its competition at such prevention, said Dow Jones earlier this week, the medication was found to increase bleeding in patients in clinical studies, the FDA revealed.  Regardless, the panel voted 15-to-2 in favor of the drug, made by Johnson & Johnson (J&J) as part of a joint venture with Bayer AG’s health care unit, said HealthDay News, which noted that while the FDA is not required to follow its advisory’s findings, it generally does.

Rivaroxaban is sold in Europe under the brand name Xarelto and was approved there last year.  The pharmaceutical companies had been awaiting FDA approval for short-term use in blood clot prevention following hip- or knee-replacement surgery.  Blood clots can be fatal if they travel to the lungs, heart, or brain and typically form in the legs, Dow Jones explained in its earlier report.  Dow Jones noted that no oral blood thinner has been approved by the FDA since warfarin in 1954; the FDA is scheduled to make its decision by May 28, according to the Associated Press, said HealthDay News.

Rivaroxaban differs from other anti-coagulants—Bristol-Myers Squibb Company’s and Sanofi Aventis SA’s Plavix and aspirin—because existing treatments ensure blood platelets do not stick together said Dow Jones, whereas rivaroxaban targets Factor Xa, an enzyme involved in blood-clotting.

« »

Leave a Reply

You must be logged in to post a comment.

NEWS CATEGORIES

GOVERNMENT NOTICES

ARCHIVES


Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!
defective-hip-replacement.com

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!
CAT-Scans-Radiation-Exposure.com

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.
WaterContaminationFrom Fracking.com

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to PCBs.com

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!
TallisPhoto.com

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Poligrip-Lawsuit.com

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!
Nassau-Personal-Injury-Lawyer-Online.com

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!
nursing-home-blog.com

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!
www.nassau-car-accident-lawyer-online.com

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!
www.suffolk-car-accident-lawyer-online.com

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!
www.veterans-benefits-denial.com

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!
www.oil-rig-spills.com

Whistle Blower

Stand up and say what you think is right. See something, say something.
whistlebloweradvisor.com