Please read! FDA Orders Stronger Warning...

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Ducky
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   Posted 9/4/2008 9:23 AM (GMT -7)   

Click here for the link...

WASHINGTON - The Food and Drug Administration is ordering stronger warnings on four medications used to treat rheumatoid arthritis.

The drugs — Humira, Cimzia, Enbrel and Remicade — work by suppressing the immune system, and the FDA says that can expose some patients to serious, even fatal, fungal infections. The agency said Thursday it has received 240 reports of one such type of infection, called histoplasmosis. In at least 21 of the cases, doctors didn't initially recognize the problem, and 12 of the patients died.

The fungus that causes the infection is common in the Mississippi and Ohio river valleys. Patients should stop taking their medication and call the doctor if they develop persistent fever, cough, shortness of breath and fatigue


Moderator of Arthritis Forum
Confirmed Diagnosis of - Psoriatic Arthritis/Spondylitis/Graves Disease/GERD/Scoliosis/Hiatal Hernia/Graves Disease of the Eyes/Chronic UTIs/Migraines/Hypertension
Current Meds -  Enbrel/Prilosec/Synthroid/Nitrofurantoin/Midrin/HYZAAR/Methotrexate
Past Meds - Inderal/PTU/Prednisone/Voltaren/Feldene/Mobic/Cortisone and Steroid Shots/HCTZ


starrnr
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Date Joined Dec 2005
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   Posted 9/4/2008 12:15 PM (GMT -7)   
Thanks Ducky for the heads up. Hope you're doing well.

~S.
Some days you're the bug, some days you're the windshield

RA, AS, intolerance/sensitivity to gluten, wheat and dairy.

Back to Enbrel 5/08 (I've gone full circle!), also currently taking .7ml (17.5 mgs) injectible Methotrexate weekly, 2 mgs Folic Acid daily


CaMama
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   Posted 9/4/2008 10:05 PM (GMT -7)   
Yikes! Is that the stuff that is found in dirt? I remember reading something about that back when I was on Remicade.

 


Kangaroo
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Date Joined Jul 2008
Total Posts : 117
   Posted 9/5/2008 8:56 AM (GMT -7)   

 It just goes to show that we shouldn't be backward in coming forward with our complaints!!!

Thanks alot for keeping abreast of things Ducky

Debbie
DebbieLou


Alicat
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Date Joined Aug 2008
Total Posts : 226
   Posted 9/5/2008 11:40 AM (GMT -7)   
Does anyone know how histoplasmosis is diagnosed?   Can they tell from a chest xray or bloodwork?    Just wondering if there are any routine tests that should be done while I'm on the Humira.
 
Thanks
 
Donna confused
psoriatic arthritis, peripheal artery disease


Ducky
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   Posted 9/6/2008 2:48 PM (GMT -7)   

Hey there.. this was taken from the Mayo Clinic's Website.. You can find all kinds of info there.. as well as signs/symptoms, etc..

Tests and diagnosis

Histoplasmosis can cause a variety of signs and symptoms, many of which resemble those of other illnesses. For that reason, it can be particularly challenging to diagnose. Complicating the matter further is the large number of tests available for detecting the presence of the fungus — each of which has some limitations. These tests include:

  • Fungal culture. This is considered the gold standard for confirming a diagnosis of histoplasmosis. During the test, a small amount of blood, sputum or tissue from your lymph nodes, lung or bone marrow is placed on a medium that enhances the growth of fungus and then checked for the presence of H. capsulatum. The drawback is the time it takes for the fungus to grow — two to four weeks and sometimes up to 12 weeks. For that reason, it's not a good choice in cases of disseminated disease where delayed treatment may prove fatal.
  • Fungal stain. In this test, a tissue sample, which may be taken from sutum, bone marrow, your lungs or a skin sore, is stained with dye and examined under a microscope. The accuracy of the test depends on the type of sample obtained and the skill and experience of the examiner. Other organisms can resemble H. capsulatum under the microscope, so confirmation with another test is desirable if an organism resembling H. capsulatum is identified.
  • Serology. This test examines blood for antigens and antibodies. It's a quick and fairly accurate way of detecting disseminated histoplasmosis as well as chronic or mild cases of the disease. But false-negative results are a problem, especially in people who have compromised immune systems or are infected with other types of fungi. The test can also be positive in people who live in endemic areas and have had past exposure to H. capsulatum, even though their current symptoms may be due to something else.

Depending on your signs and symptoms and the severity of your illness, your doctor may recommend other tests, such as:

  • Chest X-ray. Although not normally used to diagnose histoplasmosis, an ordinary chest X-ray can show inflammation and damage in your lungs.
  • Computerized tomography (CT). This X-ray technique produces more detailed images than do standard X-rays. CT can be especially helpful for detecting complications from histoplasmosis.
  • Bronchoscopy. Your doctor may use this test to help establish a diagnosis of histoplasmosis if the disease hasn't already been confirmed by a fungal culture, stain or serology test. During the procedure, your doctor examines your windpipe (trachea) and the air passages leading to your lungs using a thin, lighted tube (endoscope). A small sample of tissue (biopsy) can be taken through the endoscope.

Alicat
Regular Member


Date Joined Aug 2008
Total Posts : 226
   Posted 9/6/2008 3:21 PM (GMT -7)   

Wow, that's a lot of info and really informative.  Thanks so much. I like to be aware of these things, just in case.

Never can get too much info!  Thanks again so much.

We're getting a whole of rain here today and sure isn't helping the joints.    Still would rather be here than down South.   Although we are due for a hurricane here.  I hope we luck out again this year and miss them.  This tropical storm weather is about all I can handle.

 

Hope the sun is shining where you are and you're having a good day.

 

Donna :-)


psoriatic arthritis, peripheal artery disease


Ducky
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Date Joined Mar 2005
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   Posted 9/6/2008 3:26 PM (GMT -7)   
Hey Donna.. for now, the sun is shining.. TS Hannah just came through last night.. but the weather man is calling for rain tomorrow.. boo... :( Where are you, that you are feeling this TS weather?
Moderator of Arthritis Forum
Confirmed Diagnosis of - Psoriatic Arthritis/Spondylitis/Graves Disease/GERD/Scoliosis/Hiatal Hernia/Graves Disease of the Eyes/Chronic UTIs/Migraines/Hypertension
Current Meds -  Enbrel/Prilosec/Synthroid/Nitrofurantoin/Midrin/HYZAAR/Methotrexate
Past Meds - Inderal/PTU/Prednisone/Voltaren/Feldene/Mobic/Cortisone and Steroid Shots/HCTZ


CaMama
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   Posted 9/6/2008 10:18 PM (GMT -7)   

Thanks for the update Ducky!

Hope the weather is behaving for you folks!


 


Alicat
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Date Joined Aug 2008
Total Posts : 226
   Posted 9/7/2008 3:04 AM (GMT -7)   
Hi Ducky,

Looks like we didn't get the storm as bad as they thought. Just got up and don't see any wind damage. We got some heavy rain last night but don't think it was as much as they had thought we were going to get. I don't see any floods in the yard and hopefully there aren't any in the basement.

Supposed to clear up and the sun returns today. Now all eyes are on the new hurricane, Ike that's brewing.

I live in a little town in Massachusetts called Carver. Ever heard of Edaville Railroad? We have lots and lots of cranberry bogs here and the next town over is Plymouth, where the Pilgrims landed. How about you?
psoriatic arthritis, peripheal artery disease


Ducky
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Date Joined Mar 2005
Total Posts : 3199
   Posted 9/7/2008 7:12 AM (GMT -7)   
Yes, Ike looks terrible.. I'm worried about Jody.. :( I'm in Charleston, SC..
Moderator of Arthritis Forum
Confirmed Diagnosis of - Psoriatic Arthritis/Spondylitis/Graves Disease/GERD/Scoliosis/Hiatal Hernia/Graves Disease of the Eyes/Chronic UTIs/Migraines/Hypertension
Current Meds -  Enbrel/Prilosec/Synthroid/Nitrofurantoin/Midrin/HYZAAR/Methotrexate
Past Meds - Inderal/PTU/Prednisone/Voltaren/Feldene/Mobic/Cortisone and Steroid Shots/HCTZ


babyplace
Regular Member


Date Joined May 2007
Total Posts : 499
   Posted 9/7/2008 12:16 PM (GMT -7)   

Ok guys, now I am officially freaked....between this stuff with the enbrel and hurricane Ike....earth are we to do confused    Seriously, I am a bit nervous about Enbrel, this stuff sounds kind of scary..do you think they will take people off this med?  Not sure I want to keep taking it....but also don't want to go back to the way I was feeling before...Yes, I do live in Florida, which isn't in the area they are concerned about..but how can you be sure?

Enbrel aside...please keep praying this hurricane away....don't need anymore of these things!

Hugs to all,

Jody


Irish_Mom
Regular Member


Date Joined Apr 2007
Total Posts : 385
   Posted 9/9/2008 7:29 AM (GMT -7)   
There is also Coccidiomycosis. It's another fungal disease that comes from dirt. We're in California (Central Valley) and it's pretty common here. My son is on Humira and they said that's another one to watch out for.
Terri
 
_________________________________________________________________________________
Breast Cancer at 37; bilateral mastectomy with reconstruction.
Colon resection 2004; Sub-Total colectomy September 2007 for colonic inertia - didn't work.
Son with UC; taking Asacol and 6MP with Prednisone and Rowasa added during flareups. Recently diagnosed with ankylosing spondylitis - now on Humira. Canasa now added due to UP.
Husband with ankylosing spondylitis and psoriatic arthritis.


Alicat
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Date Joined Aug 2008
Total Posts : 226
   Posted 9/9/2008 8:44 AM (GMT -7)   

There are so many diseases I had never heard of before.  I worked for a  major health insurance company for five years and recognize a lot of them, but don't remember seeing some of them.   I guess they come  up with new names for things as more and more people get them. 

I live in Mass. so not sure if these things are a concern or not.  But never hurts to be well informed.

I have an outdoor cat who likes to hunt and I worry sometimes about getting something from him.   He gets his shots every year and has his own dishes etc.  Guess we can only be just so careful.   My cat belonged to my older brother who passed away two years ago at the age of 63.   His wife had to sell their home and move to a condo and she couldn't take him so I drove 3 1/2 hours to New Hampshire and brought him home.   He's been such a comfort to me since losing my Dad, Mom and brother all within a year and a half.   I swear sometimes that he's human.

 


psoriatic arthritis, peripheal artery disease


CaMama
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Date Joined Mar 2005
Total Posts : 1884
   Posted 9/9/2008 9:17 AM (GMT -7)   

Yeah, we live in SoCal and when I was on Remicade I was worried about camping up where they said that fungus was.....now DIRT is fatal.....<sigh> life can be ridiculous.

That is so sad about loosing so much of your family in such a short time Alicat. I'm glad to hear the cat is so much comfort. I swear my dog is part human too...of course, she seems part horse and moutain goat as well.... Anyway, don't the spiritualist say cats can be spirit guides or familiars...or something like that? (I really have no idea what I'm talking about so someone feel free to enlighten me  tongue )


 


Alicat
Regular Member


Date Joined Aug 2008
Total Posts : 226
   Posted 9/9/2008 9:39 AM (GMT -7)   

When I was little I remember Mom saying "you gotta eat a peck of dirt before you die"  Guess dirt was healthier then, ha ha.

Seriously, these meds can make a person really phobic about germs!

Waiting for the thunderstorms to arrive here today.  Don't like them at all.  My Mom used to laugh at me when I was taking care of her.   I told her she would have to sit in the hall during the storm so I could sit on the cellar stairs where I couldn't see the lightning.  Never used to be this frightened, but after seeing bolts hit three times it kinda freaked me out.\

Watch out for the dirt!

 

Alicat


psoriatic arthritis, peripheal artery disease


CaMama
Veteran Member


Date Joined Mar 2005
Total Posts : 1884
   Posted 9/9/2008 1:44 PM (GMT -7)   

LOL Alicat - me too! When I was little growing up in Mass, we had a round kitchen table with legs that came down with a metal bar around it making a little circle I could crawl in to. Every time we had a storm, I'd sit in there with my hands covering my eyes and ears! Sometimes, I'd watch TV and soon as I saw the lightening, I'd shut eyes and ears! tongue

Now I live in San Diego and we rarely have lighting/thunder storms - THANK GOODNESS! I don't mind watching them from afar on my trips, but forget about it if I have to be asleep in bed when they occur! Especially on nights my husband has to work!

I guess we can no longer say, "a little bit of dirt never killed anyone" shocked

***


 


leeloo67
Regular Member


Date Joined Aug 2006
Total Posts : 81
   Posted 9/30/2008 7:08 AM (GMT -7)   
How were those patients that got sick (and the ones that died) taking the medication? Were they the old-school twice a week Enbrel or the new once a week way? Enbrel has a half life of 60 hours, so the theory behind the once a week 50 shot vs. the two 25s per week is that the immune system has a few days to recover before you supress it again.

I've been on Enbrel for a year now and have been very very lucky - no discernable side effects whatsoever, other than two injection site reactions that lasted about a minute or two. I hope I continue to do well with it!
Arthritis (poss. RA) - Doc scripts: Enbrel 50 autoinjector, Methotrexate 5 pills/week, Folic acid. 

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