Buy this domain.
New Safety Info Added To Gilenya | cialis online

New Safety Info Added To Gilenya

AddThis Social Bookmark Button

New safety information has been added to Gilenya, manufactured by Novartis AG. Gilenya (gingolimod) is approved for the treatment of relapsing-remitting multiple sclerosis (MS) and is meant to reduce the frequency of flare-ups and delay physical disability.

Now, regulators in the United States and in Europe are placing new safety precautions on the drug, said Bloomberg Businessweek. The label change followed 15 deaths, which prompted a three-month review of Gilenya.

In its statement, the European Medicines Agency (EMA) said that physicians should not be prescribing Gilenya to those patients who have a history of cardiovascular and cerebrovascular disease or to those who take medications that lower the heart rate, wrote Businessweek. The U.S. Food & Drug Administration (FDA) set a similar rule, and also mandates an electrocardiogram prior to the first dose and, again, after the first six-hour observation period.

According to the EMA, Novartis stated that in those patients for whom Gilenya treatment is needed, heart activity should be monitored for at least overnight following the first dose and continually for at least the first six hours, according to Businessweek.

The FDA also said that monitoring should continue for at least an additional two hours in those patients whose heart rate was the lowest in the six hours following the first Gilenya dose. Also, wrote Businessweek, patients who develop significant heart problems—slow heart rate or electrical cardiac conduction issues—should be monitored at least overnight and until the issue is resolved.

In December, Novartis said one U.S. patient died within 24 hours of beginning Gilenya treatment, which prompted reviews by both the U.S. and European regulators. Reports of 10 additional deaths among Gilenya patients followed. Novartis stated that six of the deaths were unexplained, three were due to heart attacks, and one was linked to a disruption of heart rhythm.

Now, said the EMA, it has looked at a total of 15 cases involving either sudden or unexplained deaths in Gilenya patients. “Most of the deaths and cardiovascular problems had occurred in patients with a history of cardiovascular problems or taking other medicines,” the regulator said. “However, the data reviewed were not conclusive as to whether Gilenya was the cause of the deaths,” it added, wrote Businessweek.

« »

Leave a Reply

You must be logged in to post a comment.




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!

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!

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.

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

Great Photography

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

Poligrip Lawsuit

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

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!

Nursing Home Blog

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

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!

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!

Whistle Blower

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