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Timothy L. Vollmer, MD
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Brian R. Apatoff, MD, PhD
Multiple Sclerosis Institute
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Wednesday

 

Information Update - MS drug Gilenya (fingolimod): Safety information on the risk of skin cancer and a rare brain infection

















Health Canada is informing Canadians that the drug label (product monograph) for the multiple sclerosis drug Gilenya (fingolimod) has been updated with new safety information on the risk of skin cancer, as well as a rare brain infection known as progressive multifocal leukoencephalopathy (PML).
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Tuesday

 

Cases of Brain Infection Reported in MS Patients Taking Gilenya

























Multiple sclerosis patients prescribed Gilenya (fingolimod) are now being informed about a handful of documented cases where the therapy was found to have led to a rare brain infection, according to the US Food and Drug Administration. The FDA has released a public warning indicating that cases of progressive multifocal leukoencephalopathy (PML) have been reported in several patients taking the drug. Even though these PML cases are the first to be reported and linked to the drug in patients who have no history of receiving any type of immunosuppressive therapy, the FDA is now mandating Gilenya’s manufacturer, Novartis Pharmaceuticals, add the appropriate warning to the drug’s label.
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Thursday

 

Researchers Suggest Short Transition Period Between Tysabri (Natalizumab) and Gilenya (Fingolimod) Therapies to Control RRMS Disease Activity




























An international team led by researchers at the University Hospital Basel in Switzerland revealed that a short period of 8 to 12 weeks is the optimal timing to be considered when patients with relapsing-remitting multiple sclerosis (RRMS) are switched from natalizumab to fingolimod therapy. The study was recently published in the journal Neurology and is entitled “Switching from natalizumab to fingolimod, A randomized, placebo-controlled study in RRMS.”
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Sunday

 

Study Links Gilenya Side Effects to Low White Blood Cell Count

























The findings of a new study suggest that side effects of the multiple sclerosis drug Gilenya may reduce the amount of certain types of white blood cells, depressing the body’s immune system in a previously undetected way.
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Wednesday

 

STUDY: Tysabri (Natalizumab) to Gilenya (fingolimod) washout in patients at risk of PML

Upon withdrawing natalizumab, resumption of disease activity was soon observed, beginning 3–4 months after the last dose of natalizumab
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Friday's News for Neurologists: Here's 276 New Studies from 10/1 to Friday 11/1




REGIONAL PATTERNS OF GREY MATTER ATROPHY AND MAGNETISATION TRANSFER RATIO ABNORMALITIES IN MULTIPLE SCLEROSIS CLINICAL SUBGROUPS.

CANNABINOID USE IN PROGRESSIVE INFLAMMATORY BRAIN DISEASE (CUPID) MRI SUB-STUDY.

DOES JCV ANTIBODY POSITIVITY ENCOURAGE CESSATION OF TYSABRI (NATALIZUMAB) THERAPY IN MULTIPLE SCLEROSIS?

EFFICACY AND SAFETY OF TYSABRI (NATALIZUMAB) TREATMENT FOR RELAPSING-REMITTING MULTIPLE SCLEROSIS: INTERIM RESULTS OF THE TYSABRI(R) OBSERVATIONAL PROGRAMME IN THE UK.

A SERVICE DEVELOPMENT AUDIT OF FAMPRIDINE USE IN MS.

NEUTRALISING ANTIBODIES TO INTERFERON-BETA PREDICT CONVERSION TO SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS IN PATIENTS WITH MULTIPLE SCLEROSIS.

A DECADE OF DATA FOR THE UK MULTIPLE SCLEROSIS RISK-SHARING SCHEME.

PATTERNS OF COGNITIVE DYSFUNCTION IN PROGRESSIVE MULTIPLE SCLEROSIS.

FIRST USE OF ALEMTUZUMAB IN BALO CONCENTRIC SCLEROSIS: A CASE REPORT.
A regenerative approach to the treatment of multiple sclerosis.

Multiple sclerosis: An old drug plays a new trick.

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Thursday

 

BETH DEAN, NEWS EDITOR, MSnewsChannel.com - BREAKING NEWS

BREAKING NEWS: FDA Warns of PML Case With Gilenya 

"The FDA advised clinicians to report side effects involving fingolimod to its adverse-event reporting system. It also told patients currently taking the drug not to stop it without talking first with their physicians"

 I'M BETH! Watch my 57 second video


MEDSCAPE: A patient being treated for multiple sclerosis and who had no history of using natalizumab (Tysabri) developed progressive multifocal leukoencephalopathy (PML) while taking fingolimod (Gilenya), the FDA said. 

"This is the first case of this disease ... reported following the administration of Gilenya to a patient who had not previously received Tysabri," the agency said in a statement posted on its website.

The patient, living somewhere in Europe, had been on fingolimod for "nearly 8 months" when PML was diagnosed, according to the FDA. The agency stopped short of saying fingolimod caused the condition, however.

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