Not so Good News RE: Gilenya & PML

[kwarendorf]

We can't seem to catch a break!

http://www.medpagetoday.com/Neurology/MultipleSclerosis/41255?isalert=1&uun=g530414d189R5653774u&utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news&xid=NL_breakingnews_2013-08-29

[gypcwmn]

I was suppose t start taking Tecfidera a couple of months ago,

I only had to pay $10 a month, but I he er started it because

I'm afraid of what could happen. It seems the bottom line is

We're screwed if we do & screwed if we don't.

[Lulu54]

The direct link to the FDA release is

http://www.fda.gov/Drugs/DrugSafety/ucm366529.htm

[Lulu54]

I was just writing a blog about this story and find this is at least the second Gilenya/PML case.  The first was last year in a person who had been on Tysabri, which muddied the case history in tyring to determine the cause.  

This new case is a person in Europe who is Tysabri naive - having never been on it, so that is out of the equation.  71,000 people so far have taken Gilenya.

Interstingly, Tecfidera  (BG12) in its previous life as dimethyl fumarate , a psoriasis drug used in Europe, also had PML cases attributed to its use.  That link hasn't been made with its refined use for MS, but I wouldn't be surprised if that happens.

Unfortunately every drug has risks and we have to understand the risks vs benefits in making our decsions.


I second Jane's booooo's!

[JaneK1975]

Booooooo.

[doublevision1]

this is why I'm not in a rush to get on to a new non-injectable. I know they've been tested for safety but I will be more comfortable once they've been around for a while to see how larger groups of patients do on them over time.

[PastorDan]

Think I found thar article; link didn't work for me, but Google seems to have come to the rescue.

If I read what you read, this is news that was reported a month ago, but FDA is only now responding.  It involves only one patient so far, and that patient is still alive.  Despite ahving not used tysabri, they had used an interferon just before Gilenya, and steroids both before and during the Gilenya treatme t.

Worth keeping an eye on this story, for sure.