A severe side effect response to gilenya

Gilenya, or Fingolimod, is the first approved oral disease modifying drug for MS.

A severe side effect response to gilenya

Postby Cece » Sat Mar 31, 2012 6:29 pm

https://www.facebook.com/notes/ccsvi-in ... 5834334919

A Canadians first dose: "Well unfortunately it did not go well. My blood pressure dropped so quickly, to 30 bpm they sent me to VGH and after, every Doctor and their dog came to see me, as they are unfamiliar with Gilenya.

They had to call Poison Control. That's where the ER Doctors had to get the info.

I spent 26 hours in the Cardiac Care Unit, I'm good now and home but they say I'm still at risk for the next 21 days! I still have to go get a portable monitor to wear.

Remember all people react differently, and I usually react well to drugs. i was unaware that 11 people had died, when I was told 2."

Some people with CCSVI have low blood pressure to begin with.
Gilenya has been through trials, and supposedly the benefit outweighs the risk. But there is risk to taking it. There is risk to having MS. And there is, however small, a risk to having angioplasty done. We are getting the results of studies done at various centers, and these are shedding light on what the true risks are, rather than what the media or the neurologists uninvolved with studies might say.

I am glad that the outcome was ok for the Canadian who had this response to Gilenya.
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Re: A severe side effect response to gilenya

Postby David1949 » Sun Apr 01, 2012 12:38 pm

Another amazing success story from the mainstream medical community... saving patients from MS by killing them. :evil:
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Re: A severe side effect response to gilenya

Postby mscubed » Wed Jan 16, 2013 4:59 pm

So, wait. HOW many have died? What is the source for "11 deaths?" My doctor is strongly urging that I start 'Gilenya,' because 'we are running out of options.'

When he first told me about it, I left the office just shy of tossing the info in the trash can on my way to the bus. Then I thought about it a few days, read some good posts, and now this afternoon I feel like I am reading nothing but negative reviews.

I'm pretty angry because in the 6 months I was on Tysabri, the instances/risk of PML went from 1:1,000 to 1:500. Now I am being tested for it.
Also wasn't told about the Rebound Effect.

So, seeing as there are quotes of "11 patients," and not 2, as I was told, can anyone site a source for this figure? Because I'm sick of not being told things that are so critical to my health/longevity.

Thanks!
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Re: A severe side effect response to gilenya

Postby euphoniaa » Wed Jan 16, 2013 5:35 pm

mscubed wrote:So, wait. HOW many have died? What is the source for "11 deaths?" My doctor is strongly urging that I start 'Gilenya,' because 'we are running out of options.'

When he first told me about it, I left the office just shy of tossing the info in the trash can on my way to the bus. Then I thought about it a few days, read some good posts, and now this afternoon I feel like I am reading nothing but negative reviews.

I'm pretty angry because in the 6 months I was on Tysabri, the instances/risk of PML went from 1:1,000 to 1:500. Now I am being tested for it.
Also wasn't told about the Rebound Effect.

So, seeing as there are quotes of "11 patients," and not 2, as I was told, can anyone site a source for this figure? Because I'm sick of not being told things that are so critical to my health/longevity.

Thanks!


There are lots of news items from last January, 2012 about 11 deaths being investigated:
http://www.bloomberg.com/news/2012-01-2 ... hs-2-.html

I wonder how many more in the last year since they added an extended monitoring of patients taking their first dose?

Here's a quote from an article in the Jan 23, 2012 Pharma Times (also 1 year ago) that just describes the mysterious deaths they're investigating:
The latest set of opinions from the European Medicines Agency has been dominated by the news that a safety review of the benefits and risks of Novartis' oral multiple sclerosis treatment Gilenya has begun.

The agency's Committee for Medicinal Products for Human Use (CHMP) has started the probe following reports of heart problems in patients taking Gilenya (fingolimod), as well as the death of one patient in the USA less than 24 hours after the first dose. The exact cause of death is still unexplained, the agency notes.

The EMA also cited six other unexplained deaths (including three cases of sudden death) that have been after starting treatment with Gilenya, plus three deaths due to heart attack and one due to disruption of the heart rhythm. Currently, "it is not clear if these were caused by Gilenya or not", it stressed.

http://www.pharmatimes.com/Article/12-0 ... _drug.aspx
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Re: A severe side effect response to gilenya

Postby euphoniaa » Wed Jan 16, 2013 6:01 pm

And here's a link to the official Gilenya Patient Medication Guide, updated in May, 2012 to reflect the increased safety measures to avoid immediate death on the first dose & stuff. They're now keeping some patients overnight to monitor them after their first dose. My neuro asked me to look into Gilenya at my appointment last month.

Here's the link and some quotes:
http://www.pharma.us.novartis.com/produ ... ya_pmg.pdf

MEDICATION GUIDE
GILENYA™ (je-LEN-yah) (fingolimod)
Read this Medication Guide before you start using GILENYA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about GILENYA?

GILENYA may cause serious side effects, including:
1. Slow heart rate (bradycardia or bradyarrhythmia) when you start taking GILENYA.
GILENYA can cause your heart rate to slow down, especially after you take your first dose.You will have a test to check the electrical activity of your heart (ECG) before you take your first dose of GILENYA. You should stay in a medical facility for at least 6 hours after you take your first dose of GILENYA.

After you take your first dose of GILENYA:
• Your pulse and blood pressure should be checked every hour.
• You should be watched by a healthcare professional to see if you have any serious side
effects. If your heart rate slows down too much, you may have symptoms such as:
o dizziness
o tiredness
o feeling like your heart is beating slowly or skipping beats

• If you have any of the symptoms of slow heart rate, they will usually happen during
the first 6 hours after your first dose of GILENYA. Symptoms can happen up to 24
hours after you take your first GILENYA dose.

• 6 hours after you take your first dose of GILENYA you will have another ECG. If your
ECG shows any heart problems or if your heart rate is still too low or continues to
decrease, you will continue to be watched.

• If you have any serious side effects after your first dose of GILENYA, especially those
that require treatment with other medicines, you will stay in the medical facility to be
watched overnight. You will also be watched for any serious side effects for at least 6
hours after you take your second dose of GILENYA the next day.

• If you have certain types of heart problems, or if you are taking certain types of
medicines that can affect your heart, you will be watched overnight after you take your
first dose of GILENYA. Your slow heart rate will usually return to normal within 1 month after you start taking GILENYA. Call your doctor or go to the nearest emergency room right away if you have any symptoms of slow heart rate.


Besides the sudden death side effect 8O , my medical history hits a couple of the other warnings/precautions (macular edema, HIGH blood pressure), so Gilenya doesn't sound like it's for me. Although my neuro would love for me to take something. Anything. She doesn't care what I choose.
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Re: A severe side effect response to gilenya

Postby ariehs » Fri Jan 25, 2013 5:08 pm

euphoniaa wrote:Besides the sudden death side effect 8O , my medical history hits a couple of the other warnings/precautions (macular edema, HIGH blood pressure), so Gilenya doesn't sound like it's for me. Although my neuro would love for me to take something. Anything. She doesn't care what I choose.


Before I begin, please don't assume I'm being harsh or judgemental. Sometimes I sound that way in text when that's not my intention.

My experience with MS has been a roller-coaster. I have had really good periods followed by really bad ones. Things change suddenly. The saddest thing I ever saw, though, was when I went for a (highly legit) autologulous stem cell transplant. Te patient in the next bed over had been diagnosed 15 years before and for the first 10 did nothing. Then things kicked into high-gear, and overnight his life was changed. After that, he tried everything, but he had been diagnosed SPMS by then and it was unclear if anything that wasn't working by then would have helped before.

I follow a strict diet, and I exercise regularly. That helps a lot, but it helps MORE while I'm on something that works. I relapse a LOT (3-4/yr) otherwise, even though my nominal health is great. Please don't wait too long. I'm very happy on Gilenya - it's way easier than copaxone or tysabri - but even if that's not your choice, start finding what DOES work for you.

As to the "sudden death"s - When you have thousands or tens-of-thousands of people in a trial, it happens sometimes that things happen to them unrelated to the drug. Even in a double-blind, you get anomalies. I'm not saying that these people died and it was unrelated, but so far no related mechanism has been found. If it was caused by Gilenya, then it is a rare thing, with a so-far unexplained trigger. That's a good reason to worry, but don't take it too far.
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Re: A severe side effect response to gilenya

Postby euphoniaa » Sun Jan 27, 2013 8:35 am

ariehs wrote:
euphoniaa wrote:Besides the sudden death side effect 8O , my medical history hits a couple of the other warnings/precautions (macular edema, HIGH blood pressure), so Gilenya doesn't sound like it's for me. Although my neuro would love for me to take something. Anything. She doesn't care what I choose.


I follow a strict diet, and I exercise regularly. That helps a lot, but it helps MORE while I'm on something that works. I relapse a LOT (3-4/yr) otherwise, even though my nominal health is great.
Please don't wait too long. I'm very happy on Gilenya - it's way easier than copaxone or tysabri - but even if that's not your choice, start finding what DOES work for you.

Hi ariehs,

I thought I should address a couple of your comments to me, such as your admonishment, "Please don't wait too long." Well, I'm 62, have likely had MS for 40 years, since I had to be literally carried to the ER at the age of 22. And considering some of the weird physical episodes in my childhood recollections, it's quite possible I had MS even that long ago.

And "what DOES work" well for my overall health, has been the diet and exercise plan I established about 25 years ago. At the time of my surprise MS dx almost 10 years ago, the only complaint I gave a doctor was a tremor in one finger. I still work full-time (even overtime) and daily I still navigate flights of stairs while I'm there.

I have Really Old MS. It's pretty silly at this point for anyone to consider me still RR, and none of these meds are really intended for old, progressive MS. I can never get a straight answer from my neuro about why she still noted me as RR on her reports - until the last one, where she just says I have "Multiple Sclerosis." I always report no sign of a relapse.

My previous neuro said I was too far gone for Copaxone, my current neuro agrees no interferons due to my history of suicide ideation, so she asked me to research all the new ones - the ones that are still developing their true safety profiles outside a trial. When it comes to Gilenya, I hit the other precautions anyway, which makes it a bad choice for me.
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Re: A severe side effect response to gilenya

Postby euphoniaa » Sun Jan 27, 2013 2:11 pm

ariehs wrote:As to the "sudden death"s - When you have thousands or tens-of-thousands of people in a trial, it happens sometimes that things happen to them unrelated to the drug.


Hi again, ariehs,

I hate to keep pounding on this topic, but I think it's important to give our TiMS readers the most accurate info possible when their lives are on the line. So... according to the actual prescribing information, here are the total numbers in the 2 fingolimod trials (now Gilenya) - 1,703 patients, not "thousands or tens-of-thousands of people". That's why they don't have a truly accurate safety profile until the drugs are distributed into the general population. Here's a quote:

6.1 Clinical Trials Experience
A total of 1703 patients on GILENYA (0.5 or 1.25 mg once daily) constituted the safety population in the 2 controlled studies in patients with relapsing remitting MS (RRMS) [see Clinical Studies (14)].

Study 1 was a 2-year placebo-controlled clinical study in 1272 MS patients treated with GILENYA 0.5 mg (n=425), GILENYA 1.25 mg (n=429) or placebo (n= 418).

Adverse reactions in Study 2, a 1-year active-controlled (vs. interferon beta-1a, n=431) study including 849 patients with MS treated with fingolimod, were generally similar to those in Study 1.
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Re: A severe side effect response to gilenya

Postby ariehs » Sat Feb 02, 2013 1:55 pm

euphoniaa wrote:
ariehs wrote:As to the "sudden death"s - When you have thousands or tens-of-thousands of people in a trial, it happens sometimes that things happen to them unrelated to the drug.


Hi again, ariehs,

I hate to keep pounding on this topic, but I think it's important to give our TiMS readers the most accurate info possible when their lives are on the line. So... according to the actual prescribing information, here are the total numbers in the 2 fingolimod trials (now Gilenya) - 1,703 patients, not "thousands or tens-of-thousands of people". That's why they don't have a truly accurate safety profile until the drugs are distributed into the general population. Here's a quote:

6.1 Clinical Trials Experience
A total of 1703 patients on GILENYA (0.5 or 1.25 mg once daily) constituted the safety population in the 2 controlled studies in patients with relapsing remitting MS (RRMS) [see Clinical Studies (14)].

Study 1 was a 2-year placebo-controlled clinical study in 1272 MS patients treated with GILENYA 0.5 mg (n=425), GILENYA 1.25 mg (n=429) or placebo (n= 418).

Adverse reactions in Study 2, a 1-year active-controlled (vs. interferon beta-1a, n=431) study including 849 patients with MS treated with fingolimod, were generally similar to those in Study 1.


euphoniaa, I'm sorry to say it, but you're cherry-picking your numbers. You've chosen to discuss the number of people who died from a group that is FAR larger than the groups you cited just now. THOSE numbers are the people in the original safety studies. By listing one fact from one group, and another from a different group, you're creating a false correlation.

I am not trying to argue that YOU specifically should be on Gilenya. I do think that whatever your age you are best off making sure things don't get worse. It can be sudden, and you and I both know that MS can sit comparatively quiet for decades and the change over the course of a day - RRMS is defined not by time, but by disease activity, and even that is a very gray line. I'm not here to nag you, though, I only wanted to encourage you once (now twice) not to stop looking. New treatments are coming fast, these days, as opposed to most of your life with MS.
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Re: A severe side effect response to gilenya

Postby mscubed » Fri Feb 22, 2013 7:46 pm

So, ultimately, after a lot of research and back-n-forth, I decided NOT to chance the Gilenya effects. I started having seizures again, which puts me BACK on the "observation table" for post-Tysabri PML. Instead of Gilenya (Aubagio was never an option in my belly, with my neuro's concurring input), I have opted to undergo IV-Solumedrol. Granted I spent most of the post IV experience down-the-Pub, I am content. Besides the metallic taste, it's pretty cool. I don't know, Gilenya just seemed to fall under the category of "Unnecessary Risk." MSers have so many things to be alert, over- why have effed up, gnarly side-effects worsen an already murky territory? I vote "EFF NO!"
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Re: A severe side effect response to gilenya

Postby Theresaa » Sat Dec 14, 2013 9:49 am

I started G, 2 wks ago and so far I have experienced motor skills problems like cant even hold/write with a pen. loss of strength in left hand ( my writing hand) feel I should stop it but frightened to. would love some good input from anyone who has experience of G
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Re: A severe side effect response to gilenya

Postby NHE » Sat Dec 14, 2013 12:47 pm

Theresaa wrote:I started G, 2 wks ago and so far I have experienced motor skills problems like cant even hold/write with a pen. loss of strength in left hand ( my writing hand) feel I should stop it but frightened to. would love some good input from anyone who has experience of G


Hi Theresaa,
It sounds like it might be best to contact your doctor and let them know what's going on with these new symptoms.
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