new warnings on tysabri?

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new warnings on tysabri?

Postby reneelucia » Sun Jan 22, 2012 10:09 am

This came over my email today. I think its old news but maybe not to the FDA.


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

AUDIENCE: Neurology, Gastroenterology

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 using an anti-JCV antibody detection test that has been analytically and clinically validated, and has been ordered by a healthcare professional. The Stratify JCV Antibody ELISA test2 was cleared by FDA on January 20, 2012. Testing positive for anti-JCV antibodies means that a person has been exposed to JCV in the past.

BACKGROUND: Tysabri (natalizumab) is in a class of medications called immunomodulators. It works by stopping certain cells of the immune system from causing damage to the body. Tysabri is approved for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn's disease since January 2008.

RECOMMENDATION: The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. Patients with all three known risk factors have an estimated risk of PML of 11/1,000 users. See the Drug Safety Communication Data Summary section for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert
, including links to t
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reneelucia
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Re: new warnings on tysabri?

Postby civickiller » Sun Jan 22, 2012 8:15 pm

i dont want anybody to think testing negative for jcv virus means you wont get PML with tysabri

idk if its stated any where but the longer your on tysabri the increase risk rises for PML
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Re: new warnings on tysabri?

Postby HarryZ » Mon Jan 23, 2012 8:46 am

civickiller wrote:i dont want anybody to think testing negative for jcv virus means you wont get PML with tysabri

idk if its stated any where but the longer your on tysabri the increase risk rises for PML


You are absolutely correct Civic as there have been MS patients who get PML even though they have initially tested negative for the virus.

Biogen is doing a lot marketing/press release info with this new test because they know it will result in more Tysabri prescription$ being written by the neuros.
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