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New risk factor for leukoencephalopathy Progressive multifocal (PML) associated with Tysabri (natalizumab)


The Food and Drug Administration (FDA) and inform the public that have been identified to test positive for antibodies against JC (JCV) as a risk factor for HIV leukoencephalopathy progressive multifocal (PML). PML is an inflammation of the brain are rare but serious associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn's disease.
It should be that the risks and benefits of continuing treatment with Tysabri be carefully considered in patients who are found to be anti-JCV antibodies of the positive and you have one or more of the other risk factors known to the PML. Patients who suffer from all the three known risk factors have estimated the risk of PML of 11/1 for users, 000. Risk factors are:The presence of antibodies against JCV.Longer duration of treatment Tysabri, especially after 2 years.Before treatment with immunosuppressive drugs (for example, mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or inhibition mofetil).
Has been revised drug label for Tysabri to reflect this updated information including the schedule of estimating the rate of PML stratified by three known risk factors.
Can determine the status of the patient's antibodies to anti-JCV antibody detection using the anti-JCV test that has been verified analytically and clinically, and ordered by a physician. JCV was cleared applied body ELISA test by the FDA on January 20, 2012.Test positive for anti-JCV antibodies means that a person is exposed to JCV in the past
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Comments

  1. Anonymous16 April 2012 at 14:27

    This is going to be a conclusive test for MS patients opting for Tysabri as treatment. In case the patients is tested positive certain measures should be taken:
    -closer monitoring for any signs of PML;
    -decrease the time between MRI scans.
    The doctors treating patients more susceptible to PML should be prepared to offer progressive multifocal leukoencephalopathy treatments as fast as possible.

    ReplyDelete

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