Gilenya and PML

[msmything]

Has anyone heard any details with regard to the case of the woman in Germany? who came down with PML as is a danger in Tysabri? I had just decided "enough with these injections!" NO MORE! Now a connection, no matter how tenuous, to PML makes my stomach spin.

[CaliReader]

Here is the first half of an article from MedPage Today.

Steroids and Azathioprine seem to be the other possible factors. I won't be taking steroids while on this drug.

FDA Warns of PML Case With Gilenya
Published: Aug 29, 2013

By John Gever, Deputy Managing Editor, MedPage Today
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SILVER SPRING, Md. -- 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.

"We are working with Gilenya's manufacturer, Novartis, to obtain and review all available information about this occurrence," the agency said. "We will communicate our final conclusions and recommendations after our evaluation is complete."

For its part, Novartis issued a statement indicating that the firm does not believe fingolimod was responsible for PML in this case, which it had reported publicly in late July.

"Having reviewed all available information, Novartis considers that several features of this case of PML make it unlikely to be attributable to Gilenya," the company asserted.

Fingolimod was not the only drug the patient had been taking, both Novartis and the FDA noted.

"The patient had been treated with interferon beta-1a and azathioprine for 1 month before initiating Gilenya treatment; those medications were stopped when Gilenya was started. The patient also received multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment," according to the FDA.

[centenarian100]

"Novartis issued a statement indicating that the firm does not believe fingolimod was responsible for PML in this case"

Hahaha. Of course fingolimod isn't responsible per Novartis!

Man that cracks me up

[CureOrBust]

I liked the "in this case" which to me sounds like they know of another case that the press/public don't know about.

[cheerleader]

I would suggest that any considering Gilenya read the Institute for Safe Medicine Practices full report on fingolimod/Gilenya from 2011.
http://www.ismp.org/QuarterWatch/pdfs/2011Q2.pdf

The Institute for Safe Medicine Practices has zeroed in on Novartis' ($NVS) new multiple sclerosis pill, Gilenya. In the wake of 11 deaths among Gilenya patients--and amid U.S and European reviews of its safety--the not-for-profit group sifted adverse event reports, concluding that Novartis and the FDA should consider restricting its use.

Sixty-eight reports of serious infections hit the register during the second quarter of last year, including one herpes infection that ended in death. Sixty eye-related side effects were also reported, including macular edema and vision disruptions. In 14 cases, Gilenya patients experienced more generalized symptoms, including heart-rhythm problems and liver damage.

Here's my write up on how Gilenya flew thru the FDA approval process:
http://ccsviinms.blogspot.com/2013/10/t ... rosis.html

cheer

[HarryZ]

Unfortunately, as the drug companies continue to produce stronger and more powerful immune system altering medications for the treatment of MS, we are going to see more and more PML and other related infectious side effects from their use. Sad but true!

Harry