US FDA adds PML warning to Gilenya drug label

[agate]

The MS drug Gilenya will now have a warning about PML on its label according to the US FDA:

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[SuzE-Q]

Thanks.

Wonder if those new to MS or research take this as lightly as most people take the long list of warnings on the insert of a bottle of aspirin? Or just rely on their doctor's advice and go in some what blindly or only focused on the benefits?

[agate]

A 3rd PML case connected with Gilenya:

From Medscape, August 18, 2015:

Quote

Third Case of PML With Fingolimod (Gilenya) in MS

Megan Brooks

Freelance writer, Medscape

Disclosure: Megan Brooks has disclosed no relevant financial relationships.

Novartis has been notified of a third case of progressive multifocal leukoencephalopathy (PML) in a patient with relapsing multiple sclerosis (MS) treated with fingolimod (Gilenya).

According to an August 17 notice on the company's Gilenya Information Center Web page, the diagnosis of PML was based on suggestive clinical symptoms, magnetic resonance imaging findings, and tests for JC virus. The patient did not have prior exposure to natalizumab (Tysabri, Biogen) treatment, which is already associated with increased PML risk.

The patient has a history of colorectal cancer treated with chemotherapy and radiation treatment, as well as Crohn's disease, and Novartis says they are currently in "active discussions with external advisors to review details of this case and the role of various risk factors contributing to the development of PML."

Earlier this month, the US Food and Drug Administration (FDA) warned that a case of definite PML and a case of probable PML have been seen in patients taking fingolimod for relapsing MS, as reported by Medscape Medical News. Neither of these patients had previously received natalizumab treatment.

The first case was a 49-year-old who developed probable PML after taking fingolimod for approximately 4 years. The patient had a 5-year history of MS and had previously been treated for relapse with interferon beta-1a (Rebif) for 10 months in addition to short-term corticosteroids before and during fingolimod treatment.

The second case was a 54-year-old who developed PML after taking fingolimod for approximately 2.5 years. The patient had a 13- to 14-year history of MS and had previously been treated with interferon beta-1b for approximately 11 years, as well as with mesalazine for ulcerative colitis for the last 4 years.

....

In the August 17 notice, Novartis says with more than 125,000 patients have been treated with fingolimod and 240,000 patient years of exposure in both clinical trials and postmarketing setting, they continue to "stand behind the positive benefit-risk profile" of the drug in relapsing MS.

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[Howie]

Why take the chance, don't let a doctor talk you into it.