Chronic Fatigue Syndrome-any FDA approved meds?

[whopper]

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I have a patient who has chronic fatigue due to the effects of Epstein Barr Virus. She is not a substance abuser, and I've been able to keep her fatigue well controlled with Provigil.

Since Cephalon no longer gives out samples of this (thanks to Nuvigil) and since neither Nuvigil or Provigil has an FDA approval for fatigue due to Epstein Barr, I'm fearing I will no longer be able to provide this medication for her. Her insurance won't cover it, nor will patient assistance help unless she has an FDA approved reason to be on it.

Provigil does have an FDA approval for fatigue from multiple sclerosis, but not from Epstein Barr.

So, we got 2 months of sample left. After that--she's SOTL unless I can figure out something else to give her to help her fatigue. Anyone here know of any FDA approved meds for chronic fatigue syndrome?

 

[OldPsychDoc]

Why not methylphenidate?

 

[Regnvejr]

Or apply for getting the provigil off-label. I have done that with EBV before, just need a sleep study first. You got a few months to set it in motion, so you should be OK. That's about the time it takes me to get a PA on Provigil.

 

[masterofmonkeys]

Might also be worth it to try some cortisol studies and hook them up with an endo who knows CFS.

If they have the typical crappy morning cortisol levels and/or impairment on adrenal stim test, might be worth it to try some simple hydrocortisone AM & PM replacement.

 

[whopper]

Or apply for getting the provigil off-label. I have done that with EBV before, just need a sleep study first.

I have tried to get patients meds off label when it does not have an FDA approval though it has been difficult. I'm going to give this option a try though, and hope it works since I don't have many options for her, and she really does need the medication.

Might also be worth it to try some cortisol studies and hook them up with an endo who knows CFS.

I'll look into this as well, though the PCP who's supposed to be covering the EBV, well let's just say I seem to know more about it than the PCP, and I'm not expecting much to go on there.

Methylphenidate? I'll consider that.

The problem I've had with her that makes her case more frustrating, is that she's been tried on several medications and even at small dosages they cause her to be extremely ill. E.g. I just gave her Citalopram 5mg, and after we pushed it to 10 mg she became nauseous. This is a common trait in chronic fatigue syndrome. We know the provigil works, and is one of the few meds that helps her that does not get her feeling sick. She wants to avoid medications that could be potentially addicting such as methylphenidate. While I do know provigil has some abuse potential, its not as bad as the amphetamines.

 

[OldPsychDoc]

...
Methylphenidate? I'll consider that.
...She wants to avoid medications that could be potentially addicting such as methylphenidate. While I do know provigil has some abuse potential, its not as bad as the amphetamines.

In my little experience, those who worry about getting addicted are the ones least likely to actually do so...

 

[Regnvejr]

..She wants to avoid medications that could be potentially addicting such as methylphenidate. While I do know provigil has some abuse potential, its not as bad as the amphetamines.

The only ones with stimulant problems that I run into are the past addicts, and even them we can cover with stimulants. Esp. with a Strattera baseline.

GI issues are much more complicating, but you can try the Daytrana patch. It also won't give her a rush or a withdrawal feeling. Note that we still see about 10% of the users getting a contact rash, unfortunately.

 

[Regnvejr]

In my little experience, those who worry about getting addicted are the ones least likely to actually do so...

Pretty much. The more you need it, the less addictive.

 

[Sneezing]

What about Savella? It's the 'new' SNRI drug FDA approved for fibro. I hear it has a good energy kick to it, and if she has fibro, you might have a winner...

 

[masterofmonkeys]

my vote is still for going the corticosteroid route, if it applies to this person. Why not go to the root of the issue?

 

[whopper]

What about Savella? It's the 'new' SNRI drug FDA approved for fibro.

I haven't tried that one, but she was tried on pretty much every SSRI and SNRI you can think of aside from the above.

The only SSRI I haven't tried is Sertraline, and I put her on a course of it. I will see if it works.

With almost every single medication that has been tried, she showed little tolerance. As little of 10mg of Citalopram caused her to have extreme nausea. This further reinforced my belief that she has chronic fatigue syndrome for real due to EBV. As many of you know CFS is considered a BS dx by several doctors, yet she has all the classic features of the disorder (the right sx, the past history of EBV, and poor tolerance to even the most benign medications except provigil).

She is not seeking any of of the benefits that would clue one into malingering. She works, though needed to make an arrange with her boss to not work a set schedule. Her boss pays her not on the hour, but by the amount of work she performs. He is very understanding. She needs an unstructured schedule because several days a week, she doesn't have the energy to get out of bed.

 

[whopper]

my vote is still for going the corticosteroid route, if it applies to this person. Why not go to the root of the issue?

Agree--yet I'm not supposed to be treating her medical ailments as part of my agreement with my insurance company. I will though suggest that her EBV be properly treated and will call up the attending covering that issue (AGAIN!).

(Hmm, what do you do when the PCP isn't treating their medical issue, and I 've already left them a message that their (insert disorder here: hyperlipidemia, hypertension, hypothyroidism, seizure disorder) is not being treated--it's happening with a lot of my patients!

As for getting prior approval (PA) from the insurance company on provigil--nada. Rejection, and I found out by the nurse that's worked at the place for a few years (I just started there a few months ago). PA was attempted by the two previous psychiatrists, a total of 5 times, each time it was rejected because the insurance company said it was not an FDA approved reason to give provigil.

This suggests that they'll also reject pretty much any stimulant medication. I will continue trying to help her in this issue, but I'm thinking this will not be an easy road.

 

[masterofmonkeys]

god. As a resident i don't have to worry about that insurance crap. I just treat what's in front of my face.

Although given that CFS is a genuine psychoneuroendocrinological disorder, it can be argued that corticosteroids are a psychiatric treatment in this case.

 

[Regnvejr]

...As for getting prior approval (PA) from the insurance company on provigil--nada. Rejection, and I found out by the nurse that's worked at the place for a few years (I just started there a few months ago). PA was attempted by the two previous psychiatrists, a total of 5 times, each time it was rejected because the insurance company said it was not an FDA approved reason to give provigil.

Generally, I have about 3-5 circles of go-around with insurance companies (incl. a sleep study) before a final decision. At that point, it is 50:50.

 

[whopper]

Problem here is she does not have a sleep problem. Provigil is approved for sleep disorders, so doing a sleep study will if anything just make it harder to get provigil.

This is bugging me. I was always anticipating that at some point the limitations of the FDA approval system would somehow screw one of my patients. I'd really hate to put someone on methylphenidate which might not even work on her, her insurance may not even cover that medication, when we already found a safer medication that does work on her.

 

[Regnvejr]

Problem here is she does not have a sleep problem. Provigil is approved for sleep disorders, so doing a sleep study will if anything just make it harder to get provigil.

Actually, showing that there is nothing to fix with CPAP or RLS treatment will make it more likely that Provigil is needed, as nothing else worked or is fixable.

This is bugging me. I was always anticipating that at some point the limitations of the FDA approval system would somehow screw one of my patients. I'd really hate to put someone on methylphenidate which might not even work on her, her insurance may not even cover that medication, when we already found a safer medication that does work on her.

On the other hand, methylphenidate is reasonably cheap, esp. if she can get it through a community mental health center with sliding scale or similar.

 

[OldPsychDoc]

Actually, showing that there is nothing to fix with CPAP or RLS treatment will make it more likely that Provigil is needed, as nothing else worked or is fixable.
On the other hand, methylphenidate is reasonably cheap, esp. if she can get it through a community mental health center with sliding scale or similar.

Meth is cheaper... 🙄

(OK--I'm going to burn in hell for that, but I just filed for a commitment on a wreck of a female who tried threatening her psychiatrist to get Desoxyn-- basically so that when her urines were positive for methamphetamine, her PO and CPS worker couldn't violate her, since she "had a script for it". So I'm feeling quite cynical today. (Kudos to my colleague, who told her, "Sure, and why don't I just call the State Board today and hand in my license, too?" ))

 

[Regnvejr]

...but I just filed for a commitment on a wreck of a female who tried threatening her psychiatrist to get Desoxyn-- basically so that when her urines were positive for methamphetamine, her PO and CPS worker couldn't violate her, since she "had a script for it". ...

LOL, I thought that only had happened to me. 🙂

 

[Suprachiasmatik]

I have tried to get patients meds off label when it does not have an FDA approval though it has been difficult. I'm going to give this option a try though, and hope it works since I don't have many options for her, and she really does need the medication.


I'll look into this as well, though the PCP who's supposed to be covering the EBV, well let's just say I seem to know more about it than the PCP, and I'm not expecting much to go on there.

Methylphenidate? I'll consider that.

The problem I've had with her that makes her case more frustrating, is that she's been tried on several medications and even at small dosages they cause her to be extremely ill. E.g. I just gave her Citalopram 5mg, and after we pushed it to 10 mg she became nauseous. This is a common trait in chronic fatigue syndrome. We know the provigil works, and is one of the few meds that helps her that does not get her feeling sick. She wants to avoid medications that could be potentially addicting such as methylphenidate. While I do know provigil has some abuse potential, its not as bad as the amphetamines.

I know this an old post, but do you have any literature that supports your assertion that intolerance to SSRIs is common in CFS?

I had a similar reaction to Escitalopram...violent nausea [sickest I've ever felt in my life!]. I also have chronic fatigue.

 

[Shikima]

I know this an old post, but do you have any literature that supports your assertion that intolerance to SSRIs is common in CFS?

I had a similar reaction to Escitalopram...violent nausea [sickest I've ever felt in my life!]. I also have chronic fatigue.

Too much of a good thing - 5HT.

 

[Suprachiasmatik]

Too much of a good thing - 5HT.

That would make sense, and I do see some articles that discuss elevated serotonergic activity in CFS sufferers.

There are 3 things that seem to help my chronic fatigue: fasting and, in the short term, prednisone and/or stimulants.

Hopefully some more people will chime in.

 

[birchswing]

According to GoodRx, a month of Provigil at Costco pharmacy is $35.