Monday, May 8, 2017

Gilenya (Fingolimod) for MS - worth the side effects?

Gilenya, or Fingolimod, was originally developed to treat cancer but in the trials, was considered "unsafe" (too many side effects) for cancer patients.

So now they are really pushing it (heavy TV advertising) for MS (Multiple Sclerosis).

It's, at best, what they call a "disease reducing" drug meaning, it MAY reduce the symptoms of MS and now they apparently have a couple of trials of short duration (1 or 2 years) suggesting this in some patients. Were you to read the trials, you would likely, find they were on newly diagnosed patients who don't have many relapses anyway.  But the side effects, if you read them through, should scare anyone away from this drug (especially if one considers that it was too dangerous for cancer patients!).

Here are some of the side effects...

1. the slowing of heart rate (especially after the first dose). In the safety info they warn the patient to get an ECG to make sure all is OK.  Good stuff, not! Heartrate "usually returns to normal rate". Usually is not "always" and patients are warned to immediately seek attention if they feel dizzy or tired or feel like their hearts are beating slowly. They suggest 24 hour monitoring for the first dose at least. UH, I don't think trading heart disease for a slight reduction of symptoms would be worth this drug, and living with someone with heart disease, I can attest to the fact, it's not pretty.  MS patients are often desperate enough to grab at straws... this one may not be worth grabbing at.

2. But we are not done with side effects.  People with MS tend to have a compromised immune system so I'm not sure they will be pleased to find out that Gilenya might FURTHER compromise their immune system that is, they may get other diseases (including meningitis). Just what you always wanted, right? So the safety info says to warn your doctor if you are feeling confusion, dizziness, neck stiffness, or light sensitivity. (which you can have anyway with MS).

3. Gilenya can cause a usually rare but serious illness called PML because it works by reducing ALL the lymphocyte cells in your blood.  The lymphocytes are kind of like the police officers which go through the blood stream searching for invader bacteria - they attack the bacteria before it can cause a lot of damage.  You don't want to reduce these cells.  They are important and especially in folks with weakened immune systems to begin with. Symtoms of PML can include, lack of balance, weakness on one side of your body, or trouble using your arms and legs (according to the Gilenya safety info)

4. Macular edema or swelling of the macula part of the eye can also occur with this drug, causing vision problems including blurriness, shadows or a blind spot in the middle of your eye.

5. Swelling or narrowing of the blood vessels of the brain which they warn, in the safety info, can cause a stroke (and you do NOT want a stroke which can cause serious disability ADDED to any disability MS may be causing or worse.).

6. Gilenya can also cause shortness of breath or breathing problems.

7. And liver problems - Gilenya can cause liver problems too.

8. Finally last but not least, Gilenya can cause cancer (basal cell carcinoma) so you have to be on constant cancer watch.

A no brainer is, if you are pregnant (which if you have MS you should consider NOT being), Gilenya can harm the unborn baby.

And for all these risks, you are not guaranteed, it's going to help your MS.  The safety info states it CAN cut down MS relapses by 50% - Those don't seem good odds for me.

Not when the old advice the MS society used to give (before they were uh, "romanced" by the pharmaceuticals) of "some sitting, some standing, some lying down" worked the best (with no medications!).  MS typically starts earlier in life than diagnosed - sometimes even in kids and runs a course of about 25 years (as long as it takes your body to replace the lyphocyte B cells some of which are affected by the virus).  It's well worth waiting it out because after it runs its course, you can pretty much regain your former health.  I know that from experience.

Buyer beware - be very careful because in today's crazy society, risky medications are being heavily sold on TV. Knowing that MS goes into arrest after 25 years, if carefully handled, may make it worth waiting for and light range of motion exercises while you are waiting, are a good idea in addition to good diet, lots of rest and patience. And perhaps not indulging in a medication which isn't all that effective and can cause side effects you don't want.

Sadly, some MS patients are desperate for immediate relief of symptoms - so they don't bother reading the small print - I met a lady who had 2 boys and was using a wheelchair.  When she told me she was on "Gilenya", I said,"But that's a risky medication." Her response?  "Who cares", she said, shrugging her shoulders.

Bottom line, medicine is a business, first and foremost.