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   DIR Return to: GILENYA (fingolimod, FTY720)
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       #Post#: 887--------------------------------------------------
       Gilenya label to include PML warning according to FDA
   DIR By: agate
       Date: August 4, 2015, 6:29 pm
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       From MedPage Today, August 4, 2015:
       --- Quote ---
       > FDA Warns of Fingolimod PML Cases
       >
       > Neither patient had been on a previous immunosuppressive agent
       >
       > by Kristina Fiore
       > Staff Writer, MedPage Today
       >
       > The FDA has warned about two cases of progressive multifocal
       leukoencephalopathy (PML) -- one definitive, one probable -- in
       patients taking fingolimod (Gilenya) for multiple sclerosis
       (MS).
       >
       > The agency said these are the first cases to be tied to the
       drug in patients who haven't been on other immunotherapies. A
       previous case of PML, reported in 2013, couldn't be definitively
       tied to fingolimod because the patient had been on other
       immunosuppressant drugs, including interferon-beta and
       azathioprine.
       >
       >
       > That patient had also been taking intravenous corticosteroids
       while on fingolimod.
       >
       > At that time, fingolimod drugmaker Novartis said in a
       statement that "several features of this case of PML make it
       unlikely to be attributable to Gilenya."
       >
       > For the two new cases FDA is reporting, neither patient had
       been previously treated with an immunosuppressant drug for MS or
       any other medical condition.
       >
       > FDA recommended that patients taking fingolimod should contact
       their physicians immediately if they experience symptoms such as
       new or worsening weakness, increased trouble using their arms or
       legs, or changes in thinking, eyesight, strength, or balance.
       >
       > Fingolimod joins other MS treatments that have also been
       associated with PML, including natalizumab (Tysabri) and
       extended-release dimethyl fumarate (Tecfidera).
       --- End Quote ---
       The article can be seen here
  HTML http://www.medpagetoday.com/Neurology/MultipleSclerosis/52930.
       #Post#: 888--------------------------------------------------
       Re: Gilenya label to include PML warning according to FDA
   DIR By: agate
       Date: August 6, 2015, 9:22 am
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       The actual alert as it appears on Drugs.com can be seen here
  HTML http://www.drugs.com/fda/gilenya-fingolimod-safety-communication-fda-warns-cases-rare-brain-infection-13745.html?utm_source=ddc&utm_medium=email&utm_campaign=FDA+Alert+-+Drug+Safety+Communication%3A+Gilenya+%28fingolimod%29+-+FDA+Warns+About+Cases+of+Rare+Brain+Infection.
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