Buy this domain.
Novartis Announces Tekturna Label Changes, Valturna Withdrawal | 24-7-news.com cialis online

Novartis Announces Tekturna Label Changes, Valturna Withdrawal

AddThis Social Bookmark Button

Novartis just announced label changes to its blockbuster hypertension medication, Tekturna (aliskiren), in the United States, following a U.S. Food & Drug Administration (FDA) review. The company also said it will pull another aliksiren product, Valturna, from the market by July 20, 2012.

The agency review involved preliminary findings from the ALTITUDE study, which was meant to review aliskiren’s effect, including the brand Tekturna, on the possibility of adverse reactions to the cardiovascular system and kidneys in high-risk diabetes patients, explained NewsInferno. More than 8,600 type-2 diabetes patients were enrolled in ALTITUDE and treated with either aliskiren or a placebo, along with their regularly prescribed blood pressure medication—either an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).

Novartis brought Tekturna to market in 2007, with hopes of blockbuster status. Tekturna is approved for high blood pressure treatment and is used as either a monotherapy (alone) or in combination with other medications, said NewsInferno.

The ALTITUDE trial was ceased this past December following findings by an independent review committee that found higher adverse events in patients receiving aliskiren in addition to standard of care. An increased incidence of serious side effects in the high-risk group was seen after 18-24 months and included nonfatal stroke, kidney complications, hyperkalemia, and hypotension. Novartis also stopped promotion of Tekturna and combination products containing aliskiren that are taken in combination with an ACE inhibitor or ARB.

The new label changes include a contraindication against combined use of aliskiren-based products with ACE inhibitors or ARBs in diabetic patients. The FDA also requested inclusion of a warning against the use of aliskiren-based products in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) taking an ACE inhibitor or an ARB. Aliskiren-based products will continue to be available in the U.S. for the treatment of high blood pressure in appropriate patients. GFR—Glomerular Filtration Rate—is a marker of kidney functioning, explained NewsInferno.

Novartis, after consulting with the FDA, is also stopping its promotion in the U.S. of Valturna (aliskiren and valsartan, USP), a single pill combination of aliskiren and the ARB valsartan. Novartis is also withdrawing marketing authorization of the same combination pill in Switzerland, known there as RasivalR (aliskiren and valsartan), which received marketing approval for export but was not launched.

Possible Tekturna side effects include nonfatal strokes; heart attacks; acute kidney failure and other kidney complications; hyperkalemia, a condition caused by abnormally high levels of potassium in the blood; hypotension, which is abnormally low blood pressure; and syncope, which is a loss of consciousness.

« »

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