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       #Post#: 887--------------------------------------------------
       Gilenya label to include PML warning according to FDA
       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).[/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
       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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