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MS Drug Tysabri (Natalizumab) Poses Hard Choices for Women Wanting Children

Posted 8 Feb 2018 by Drugs.com

THURSDAY, Feb. 8, 2018 – A powerful multiple sclerosis drug presents women with a tough dilemma if they would like to have children, a pair of new studies suggests. Those who take Tysabri (natalizumab) to manage their MS are more likely to suffer a relapse during pregnancy if they stop taking the drug before they conceive, the first study found. But if a woman remains on Tysabri while trying to ...

MS Drug Tied to Higher Risk for Potentially Deadly Brain Virus

Posted 28 Jan 2016 by Drugs.com

WEDNESDAY, Jan. 27, 2016 – People with multiple sclerosis who are treated with the drug Tysabri (natalizumab) may have up to a 10 times greater risk for a rare and potentially deadly viral infection, a new study finds. The germ in question is the John Cunningham virus (JCV), a pathogen thought to cause a deadly brain condition known as progressive multifocal leukoencephalopathy (PML). The link ...

Kidney Woes Tied to Raised Cancer Risk, Study Finds

Posted 12 Nov 2015 by Drugs.com

THURSDAY, Nov. 12, 2015 – Kidney failure and having a kidney transplant may increase the risk for certain types of cancer, a new study suggests. Poor kidney function and immune system-suppressing drugs may be behind this increased risk, according to Elizabeth Yanik, of the U.S. National Cancer Institute, and colleagues. For the study, published in the Nov. 12 online edition of the Journal of the ...

New Clues to Link Between MS Drug Tysabri and Rare Brain Disease

Posted 25 Mar 2014 by Drugs.com

TUESDAY, March 25, 2014 – Researchers report that they think they have figured out why patients who take the multiple sclerosis drug Tysabri face a high risk of developing a rare, and sometimes fatal, brain infection. A common virus that can cause the brain disease progressive multifocal leukoencephalopathy (PML) likes to infect and hide in certain blood cells that are triggered to mobilize by ...

Study Shows MS Patients at Most Risk for Drug-Linked Brain Illness

Posted 16 May 2012 by Drugs.com

WEDNESDAY, May 16 – Drug company researchers say they've determined which multiple sclerosis patients are most vulnerable to developing a rare brain infection while taking a powerful drug called Tysabri (natalizumab). Even the multiple sclerosis patients at highest risk of developing the brain infection face low odds of getting it while on Tysabri, but the infection can be deadly. "Now we can ...

FDA Medwatch Alert: Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

Posted 23 Jan 2012 by Drugs.com

ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn's disease. A patient's anti-JCV antibody status may be determined ...

First Test Approved to Help Detect Risk of Rare Brain Infection

Posted 22 Jan 2012 by Drugs.com

FRIDAY, Jan. 20 – The first test to help determine the risk of a rare brain infection among users of the drug Tysabri has been approved by the U.S. Food and Drug Administration. Tysabri (natalizumab) is commonly prescribed to treat multiple sclerosis or Crohn's disease. A relatively small number of users have developed a rare brain infection called progressive multifocal leukoencephalopathy ...

FDA Medwatch Alert: Tysabri (natalizumab): Update of Healthcare Professional Information

Posted 2 May 2011 by Drugs.com

[UPDATED Posted 04/22/2011] FDA has updated the Tysabri (natalizumab) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri for the treatment of multiple sclerosis (MS) and Crohn's disease. The update includes new safety information about patients who have ...

Scientists Find Clue to Dangerous Side Effect of MS Drug

Posted 25 Jan 2010 by Drugs.com

WEDNESDAY, Sept. 9 – Scientists may have discovered part of the reason why Tysabri, a drug used to treat multiple sclerosis, may lead to the development of a rare but potentially deadly brain disease in some patients. The drug seems to rouse the typically dormant JC virus from its slumber, allowing it to cross into the brain. Although this finding may lead to a way of predicting who is at risk ...

FDA Medwatch Alert: Tysabri (natalizumab) - Aug 25, 2008

Posted 25 Aug 2008 by Drugs.com

[Posted 08/25/2008] FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year. PML, which is usually fatal, is a known risk of Tysabri treatment, but previous cases in patients with multiple sclerosis were seen in combination with other immunomodulatory ...

FDA Medwatch Alert: Tysabri (natalizumab - Feb 27, 2008

Posted 27 Feb 2008 by Drugs.com

[Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an ...

FDA Medwatch Alert: Tysabri (natalizumab) - Jun 5, 2006

Posted 5 Jun 2006 by Drugs.com

[UPDATE 07/21/2006] Dear Healthcare Provider Letter issued. [Posted 06/05/2006] FDA notified healthcare professionals of the resumed marketing, with a special restricted distribution program of Tysabri (natalizumab), a monoclonal antibody for the treatment of patients with relapsing forms of multiple sclerosis. Tysabri was initially approved by the FDA in November 2004, but was withdrawn by the ...

FDA Medwatch Alert: Tysabri (natalizumab) - Feb 2, 2005

Posted 28 Feb 2005 by Drugs.com

[02/28/2005] FDA issued a public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (natalizumab) due to two serious adverse events reported with its use. FDA received reports of one confirmed, fatal case and one possible case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for multiple sclerosis. Although the ...

Tysabri May Treat Myelin Sheath Damage From MS

Posted 28 Apr 2009 by Drugs.com

TUESDAY, April 28 – The drug Tysabri (natalizumab) appears to regenerate and stabilize damage done to the myelin sheath in people with multiple sclerosis (MS), a study from drug makers Biogen Idec and Elan Corp shows. MS is nervous system disease that affects the brain and spinal cord. Symptoms experienced by MS patients are caused by damage to the myelin sheath that surrounds and protects nerve ...

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