Fingolimod (Gilenya) and PML

[MrsChip]

I was recently sent information from an MS Research Team in the UK asking if i wished to participate in a trial of Fingolimod. It involved taking the drug for 4 months and midway having a flu shot. I guess they were trying to ascertain what the bodys reaction to a flu shot is as Fingolimod causes the body to store the T Cells in the Lymph Glands hence increasing the chances of infections (dont really get this as I thought flu shots were a dead virus)? I've already has my shot so couldnt participate anyway.

Anyway, in the literature it carried a lengthy warning that this drug has PML as a rare side effect in a tiny number of people. I knew that Tysabri carried this risk but not Fingolimod (Glienya).

Anyone got any info on this please?

[Redwings]

Hi MrsChip:
Any medication or condition that suppresses the immune system can cause PML. Tysabri, for some reason, seems to set up especially favorable conditions for it, but it can occur with any immunosuppressant medication. A couple of years ago there was an alert issued about a patient with lupus who developed PML after taking Rituxan. Otherwise, it doesn't happen often enough to get any publicity.

PML just seems to be a quietly accepted risk with immunosuppressant medications, and is nonspecifically included under the "risk of serious infection" that's listed as a possible adverse effect. I currently take three different immunnosupressants and PML isn't specified as a risk for any of them. It could be that PML was specifically mentioned in the literature you read because it was a disclosure for a drug trial. At least in the "civilized world" that includes the US and the UK, drug trials require a detailed "informed consent" that isn't required after the drug is approved for the marketplace.

PML was a surprise that showed up a few years into Tysabri use. It might also be a surprise that shows up later as some of the newer MS medications come into more widespread use.

[Cindarelly]

I would agree the list of side effects with all drugs can go on and on.
They do have to list EVERYTHING that occurred at the time the drug was being tested.
This is why it's really important to read all the information.
I think we are all a little jumpy about a new drug, I know I am. We all know they learned things about TY they had not known until it had been out longer.. so we are a little more nervous.
It just can't be helped.

[MrsChip]

Thanks very much for the info - it makes sense now that any immunosuppressant could potentially allow opportunistic infections in, and that with a trial, they have to cover every possibility no matter how remote.

I totally agree that we all need to keep this in perspective and you can't waste your time worrying about every tiny risk as we all have enough to deal with with the MS!!