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New FDA cellcept black box warning


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#1 fragiledancer2

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Posted 09 July 2008 - 10:10 AM

Hi everyone- I just came from my rheumatologist today who took me off Cellcept cold turkey. He said the Fda recently has come out with a new black box warning having found that 12 patients on Cellcept contracted the same neurologicaL disease that ms patients got from their new wonder drug. It is unlike him to be hasty and I wonder if any of your doctors have done the same-I couldn't find any previous posts on it.

#2 janey

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Posted 09 July 2008 - 04:08 PM

fragiledancer,
Thanks for bringing this to our attention!
Here are some excerpts from the letter.

"...new postmarketing
safety information has been added to the WARNINGS and ADVERSE REACTIONS sections (for MMF)"

"Cases of progressive multifocal leukoencephalopathy
(PML) have been reported in patients treated with mycophenolate mofetil (MMF)."

"Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been
reported in patients treated with mycophenolate mofetil (MMF). Hemiparesis, apathy,
confusion, cognitive deficiencies and ataxia were the most frequent clinical features observed."

"PML is a rare, progressive, demyelinating disease of the central nervous system (CNS) that
usually leads to death or severe disability."

"Novartis global safety database for MPA has no cases of PML. Because MMF is converted to
MPA, both drugs carry the same risk in humans."

"Roche has confirmed that ten confirmed and seven possible cases of PML were reported with
MMF."

"The indication for MMF use for the ten confirmed cases was as follows: six
solid organ transplant patients (three renal, two lung, and one heart transplant patient) and
four systemic lupus erythematosus (SLE) patients. The indication for MMF use for the
possible cases was as follows: four solid organ transplant patients (three renal, one heart) and
two SLE patients. The seventh possible case was an HIV positive patient who received MMF
after being diagnosed with PML and who subsequently died of PML infection."

Certainly something for those of us on cellcept to be aware of. Something else on my list for my next rheumatologist appointment. The problem I have is that I've tried so many different immunosuppressants that there's not much left. My wish is that at this point I could just come off them all together. Well - if wishes were horses all beggars would ride!

Thanks again!

Big Hugs,


Janey Willis
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International Scleroderma Network (ISN)

#3 Clementine

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Posted 09 July 2008 - 04:28 PM

I discovered that same warning a couple of weeks ago, when I was researching LASIK for my eyes. My husband's opinion is that it is such a low number of people with PML that I should not worry. I have been concerned though.

How do others feel about this? I don't have another rheumatologist appointment until December.

#4 barefut

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Posted 09 July 2008 - 04:40 PM

Thanks for the info fragiledancer and Janey~

Clementine,

I'm not sure what to think. It is a small number but a number nontheless...
I have an appt withRheumy Aug 5th. I'll ask her about it and let y'all know what she says.

I wonder how soon after starting MMF did symptoms of PML present themselves? And how long did patients take MMF?

#5 janey

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Posted 09 July 2008 - 05:16 PM

Good questions. I went back and reread it but couldn't find anything about "how long", however, I did find this which is very interesting.

"Transplant patients were taking concomitant immunosuppressants including steroids, cyclosporine, tacrolimus and azathioprine; SLE patients were taking concomitant medications including steroids, cyclophosphamide, and cyclosporine."

Sounds like some heavy duty immune suppression going on. How were they able to pinpoint cellcept as the possible culprit? The mysteries of modern medicine!

As far as what I feel about it, at this point, I'm not too concerned. It appears that the cellcept has been effective in stablizing my lungs so right now I'll consider it a safe trade off. At my last visit, my rheumatologist said he plans to take me off cellcept after two years. That's about 8 months away, so I guess I'll just be more aware between now and then for any new symptoms. BUT I will bring it up at the next appointment.

Big Hugs,
Janey Willis
ISN Support Specialist
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(Retired) ISN News Director
(Retired) ISN Technical Writer for Training Manuals
International Scleroderma Network (ISN)

#6 barefut

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Posted 09 July 2008 - 06:04 PM

Good point Janey!

I wonder if those other drugs got the same warning?

Since PML is the result of an infection (if I am understanding that right) It probably does not matter how long one has been on it anyway. Also, like you said, it sounds like there was heavy duty immune suppression going on so I am not going to worry about Cellcept alone, especially since I have been on it for over 2 years now and have remained stable as well.

#7 Peggy

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Posted 10 July 2008 - 05:43 AM

Thanks for this information. I am very concerned and don't know what to think. Cellcept is my last resort and seems to be working. I also don't have an appointment with my doctor until October as I just had my quarterly checkup. This is why I love this forum as I know people stay on top of this and keep us informed. I really hope everyone asks their own doctors what they think and then share it with the rest of us so we know what we should do!

Warm hugs,

Peggy

#8 Sarahp

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Posted 04 August 2008 - 05:35 AM

I am also on CellCept. I have been taking it for two years. I see the rheumatologist August 13 and will discuss this black box warning. I will post if I learn anything at that appointment.

Has anyone else who is on CellCept had a conversation with their rheumatologist about the new warning?

#9 razz

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Posted 04 August 2008 - 06:45 AM

fragiledancer2,

I've been taking cellcept since Feb. of this year. So far, I've had no complications. I don't know how long I will be taking this drug because it works and keeps the scleroderma from recurring. As we all know, every prescription drug we take has potential side effects. We have to be aware and tuned in to our bodies for any highly unusual signs or symptoms. My doctor recommended a painkiller drug to me years back. I tried it and didn't feel right. I just knew I didn't feel normal. I mentioned to him I didn't like the way the drug made me feel and he took me off it. Years later this drug was taken off the market because it was found to be the cause of many heart attacks. One of my friends with scleroderma was taking this drug and passed away.

Before everyone rushes to their doctor, please read the FDA report that Janey provided the link for.

On a worldwide case reporting system, seventeen cases were identified of which seven passed away. Given the amount of people taking cellcept worldwide, that is a small number of cases. The majority who passed away had organ transplants.

You doctor is looking out for you and using his judgement in what he thinks is best for you. I agree, information is knowledge. It is what we do with that knowledge that determines our fate.

For now, I'll ask my doctors if I should be worried but I'll also be listening to my body.

Thanks for the information.

Hugs,
Razz

:)
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