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Wednesday, September 8, 2010

The Pros and Cons of Gilenya (Gilenia) (FTY720) - the first Oral medication for MS that will soon be FDA approved

For those that know me (Stuart Schlossman), they know that I often say, "there are pros and cons (positives & negatives)  to everything".  -- This includes the coming of the Oral Medications for MS.
Sure for many it may be easier to pop a pill rather than doing an injection, but just know there are adverse effects from the orals that can make it more dangerous than the injectable therapies or even the once a month infusion.

I obtained the information found below for you to learn more on how Gilenia works and the known side effects. ( I say known because until thousands begin using this, outside of research study, we really do not know what other side effects the medication might have)







The U.S. Food and Drug Administration (FDA) advisory panel approved the first line treatment for multiple sclerosis (MS) Gilenia is the first oral drug that Novaritis, a German drug maker, would sell under this brand name.
Gilenia (generic name Fingolimod) would be used for the relapsing form of MS. The drug significantly reduces MS attacks. The panel had approved it “safe and effective.”
The FDA panel voted 21-3 in favor of the drug, accentuating that the medication is effective in reducing the relapses of MS, which causes a host of movement and cognitive problems.
Study confirms effectiveness of Gilenia
To prove the effectiveness of the drug in dealing with MS, the Basel, Switzerland based pharmaceutical giant undertook a study on 1,200 patients suffering from the disease.
The results showed that patients who were adminstered the drug witnessed 30 percent reduction in the relapse rate compared to those taking other old drugs, such as Bayes's Betaseron and Biogen Idec's Aronex.
This drug can be consumed through mouth as previous preparation needed regular injections.
However Gilenia has some side effects like heart attack along with the lung, liver, and eye toxicity and increased risk of infection.
Gilenia is widely viewed as the most important drug in the Novartis pipeline, and many analysts predict it will achieve blockbuster status with $1 billion or more in annual sales once it hits the market.
How Gilenia works
In MS, white blood cells attack the myelin sheathes that protect nerve cells. Gilenia keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph-node door.
Fewer white blood cells mean fewer MS attacks. But it also means less protection against infections and cancers.
Side effects
However Gilenia has some side effects like heart attack along with the lung, liver, and eye toxicity and increased risk of infection.
In clinical trials, side effects linked to Gilenia included, elevated liver enzymes, muscular edema (swelling of the central portion of the retina, causing distorted vision), high blood pressure, shortness of breath, bronchitis, diarrhea, bradycardia , which is slowing of the heartbeat, seen only upon first treatment.
Two fatal herpes infections occurred in MS patients treated with Gilenia at 2.5 times the 0.5 mg dose.
Novartis has already assured to set up a careful program for educating and monitoring patients taking the drug. Moreover, the company will continue long-term studies to look for side effects that may occur with longer term use.
The FDA panel suggests that the first dose of the drug should be administered under medical supervision


Read more from the source for this information by clicking here

Then, please share this blog posting with others who may need to learn too.

Thank you



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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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6 comments:

Anonymous said...

After being on Copaxone for more than a decade I was excited to hear about the drug therapy's. Now having read your blog I will be doing a lot more research before asking my Doctor. Thanks.

Mansoor said...

I have been waiting for a cure and i see the very interesting side effects!!!

Stuart said...

Mansoor - How are things for you?
There is NO CURE yet, for MS...
Only different medications which each have various side effects and of course there is also CCSVI - which we really do not know the long term effects, complete negatives or complete positives. - Regards - Stuart

Anonymous said...

Stuart, I was in this study and had to withdraw to due to multiple, *horrible* adverse reactions. My immune system was essentially wiped out, I got some wicked infections (life-threatening) that were very difficult to get rid of. It sent my thyroid into a major hyper state. I have always had very stable blood pressure (if a bit on the low side).

I found myself having spikes so high that my doctor(s)-(cardiologist included) mentioned that the numbers were in "stroke territory" and this was danger with a capital "D". Another side/adverse effect on one of the many release forms I was asked to sign off on (there were several) was skin cancer. I am fair skinned (not milk bottle white, but "fair"), no freckles ever. BTW, I have also never been a sunbather, I hate heat and have always had an intolerance to it. I now find myself with a slew of freckles that have been popping up consistently since I started taking that pill and continue after I stopped (some raised). I saw a derm when I was in the study, but when I dropped out, all has been on MY dime (and he tells me I have to go back every six months, just in case!).

The test site and the drug co. wanted nothing to do with me the minute I reported an adverse reaction. I have been told repeatedly that I was most likely on the highest dose. I have also been told it will likely be approved and approached about whether I will consider going on the lower dose. Hmmmm (?) :O I'm thinking... NO.

Karen Lashbrook said...

I've been part of the first 3rd clinical trial, and now the extended study. Thet believe that I had the actual med for the first two years, due to the development of HBP after the first month. It has been kept under control successfully wit...h a low dose of Lisiniprol. For the 2nd part, we are on 0.5mg, due to increased heart problems with the 1.5mg dose. The HBP is the only side effect, thankfully that I've had after 3 years, one being on the drug for sure. The results, for me, have been very successful, as I've suffered on one exacerbation in the past three years. I hope to be part of the long term study!

Anonymous said...

Sorry I read this late. Every drug good and bad things about them. Some will get great benifits some awful side effects. The jury is out on this one for me so far
I am coming up on four yrs. on Tysabri. I had a 1 in 1,000 possibility to get PML. After four years who knows. I know it has kept me stable. Paula Garfield