FDA warning on stopping Gilenya

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Scott1
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FDA warning on stopping Gilenya

Post by Scott1 » Wed Nov 21, 2018 3:21 am

This came out today on the risks involved with stopping Gilenya

https://www.fda.gov/Drugs/DrugSafety/ucm626095.htm

"The Food and Drug Administration (FDA) is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability. As a result, we have added a new warning about this risk to the prescribing information of the Gilenya drug label and patient Medication Guide."

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Zyklon
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Re: FDA warning on stopping Gilenya

Post by Zyklon » Wed Nov 21, 2018 8:44 am

In the eight years since Gilenya’s 2010 approval, FDA received 35 cases of severe increase in disability accompanied by the presence of multiple new gadolinium-enhancing lesions on MRI following the discontinuation of Gilenya. All 35 patients received corticosteroids as the initial treatment. Of the six patients who were reported to have experienced a full recovery, 3 received only intravenous methylprednisolone, and the other 3 received plasma exchange, intrathecal triamcinolone, or re-started Gilenya. Other patients were also treated with plasma exchange, natalizumab, Gilenya, cyclophosphamide, rituximab, dimethyl fumarate, glatiramer, and methotrexate.
I think this is acceptable risk but needs more research.
Pain! You made me a, you made me a believer, believer
Pain! You break me down, you build me up, believer, believer
Pain! Oh let the bullets fly, oh let them rain
My life, my love, my drive, it came from... Pain!

ElliotB
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Re: FDA warning on stopping Gilenya

Post by ElliotB » Wed Nov 21, 2018 9:34 am

acceptable risk> Not in my opinion, why be a test subject especially when there are other proven drugs that are proven reasonably safe.

needs more research > definitely

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NHE
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Re: FDA warning on stopping Gilenya

Post by NHE » Thu Nov 22, 2018 1:25 am

Zyklon wrote:
In the eight years since Gilenya’s 2010 approval, FDA received 35 cases of severe increase in disability accompanied by the presence of multiple new gadolinium-enhancing lesions on MRI following the discontinuation of Gilenya. All 35 patients received corticosteroids as the initial treatment. Of the six patients who were reported to have experienced a full recovery, 3 received only intravenous methylprednisolone, and the other 3 received plasma exchange, intrathecal triamcinolone, or re-started Gilenya. Other patients were also treated with plasma exchange, natalizumab, Gilenya, cyclophosphamide, rituximab, dimethyl fumarate, glatiramer, and methotrexate.
I think this is acceptable risk but needs more research.
"6/35" Only 17% experienced full recovery.

Zyklon
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Re: FDA warning on stopping Gilenya

Post by Zyklon » Thu Nov 22, 2018 11:59 am

Out of how many patients? 35 cases in 100000? We need more data. We know lots of drugs are relatively safe to use. What about discontinue? I only know a little about immune reconstitution inflammatory syndrome. Please more research.
Pain! You made me a, you made me a believer, believer
Pain! You break me down, you build me up, believer, believer
Pain! Oh let the bullets fly, oh let them rain
My life, my love, my drive, it came from... Pain!

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