New FDA warning

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Veteran Member

Date Joined Jun 2008
Total Posts : 1058
   Posted 9/4/2008 9:42 PM (GMT -7)   
Stolen from the arthritis forum:

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

frank j
Regular Member

Date Joined Jun 2006
Total Posts : 341
   Posted 9/5/2008 5:11 AM (GMT -7)   
FDA requests stronger warnings for rheumatoid arthritis drugs.
The Wall Street Journal (9/5, B5, Favole, Wang) reports that on Thursday, the Food and Drug Administration (FDA) "demanded beefed-up warnings on the labels of four big-selling drugs for arthritis and Crohn's disease to alert patients to the risk of serious fungal infections." The stronger warning labels will apply to "Johnson & Johnson's Remicade (infliximab), Abbott Laboratories's Humira (adalimumab), Enbrel (etanercept) from Amgen, Inc. and Wyeth, and UCB SA's Cimzia (certolizumab). The companies have been cooperating fully with the FDA, said Jeffrey Siegel, M.D., leader of the FDA division that regulates arthritis products." These drugs belong to "a class of treatments known as TNF [tumor necrosis factor] blockers." The agency "said it reviewed 240 reports of histoplasmosis, a particularly invasive respiratory disease with symptoms similar to the flu, in patients being treated with Enbrel, Humira, or Remicade. The FDA found one case of the disease in a patient taking Cimzia."

The AP (9/5, Alonso-Zaldivar) provides further details on histoplasmosis, adding that it "mimics the flu, [and] is prevalent in much of the middle part of the country. It can have particularly grave consequences if it isn't caught early, and spreads beyond the respiratory system to other organs of the body." To date, "a total of 45" or about 20 percent, of the 240 cases of histoplasmosis reported to the FDA have died.

As a result of these fungal infections, "the FDA ordered the companies to strengthen existing cautions in a black box in the drugs' prescribing information," Bloomberg (9/5, Larkin) notes. The drugmakers "also must educate doctors about the risks and the symptoms of fungal infections."

HealthDay (9/4, Gardner) pointed out that "the FDA is already in the middle of a safety review of TNF blockers, including an investigation into whether or not the drugs are linked with the development of cancer, particularly lymphoma, in children and young adults." Notably, "all the drug labels already include information about possible fungal infections, but authorities expressed concern that the issue wasn't highlighted appropriately." Dr. Siegel also stated that while the warning about "the possibility of serious infectious" has always been on the labels, "what's new is that" the FDA "became aware that some physicians may not be considering the possibility of fungal infections early enough," because the fungal infections "can mimic other conditions."

AHN (9/4, Sharma), WebMD (9/4, Hitti), the UPI (9/5), MedPage Today (9/4, Neale), Medscape (9/4, Waknine), the Wall Street Journal's (9/4, Goldstein) Health Blog, and USA Today's (9/4, Winter) On Deadline blog also covered the story.

Veteran Member

Date Joined Apr 2005
Total Posts : 2346
   Posted 9/5/2008 5:33 AM (GMT -7)   
Yes! Remember my posts back in June?! I tested positive for this in June. My gi does a yearly urine histoplasmosis test, and everybody on these drugs should have one done also. It is nothing to mess around with, but if caught early, it is treatable. I never did have any symptoms from mine, thankfully, but I was instructed by my infectious disease dr. that if I did develop symptoms to immediately go to the er, and tell them that I was histo positive, and they would then admit me, call infectious disease, and start treating me.

I live in Michigan, but had traveled to southern IN, and that is where my infectious disease dr. thinks I may have picked it up. My last urine was negative, but now for the next six months I have to have the urine test done before every remicade.

If your gi does not do this test and you are on these drugs INSIST that they order it! I am so thankfully for my gi and the knowledge she has!

Regular Member

Date Joined Aug 2005
Total Posts : 296
   Posted 9/5/2008 7:12 AM (GMT -7)   
I  just read this on my local new stations main page and was coming to right it up and it was here already, this is very scary but glad some drs are on top of it.

Surgery Aug 3,2007...15 inches small and 3 inches of large intestine removed. On no meds and in my first flare since.
"Part of the secret of success in life is to eat what you like and let the food fight it out inside." Mark Twain. I love that one!!!!

Veteran Member

Date Joined Mar 2006
Total Posts : 2739
   Posted 9/5/2008 8:41 AM (GMT -7)   
Geez, and people wonder why I'm scared to go up the medication ladder! Between hearing stuff like that and the lymphoma cancer risks, I'm very leary of these medications.

Diagnosed with Crohn's Disease 2/06 after sever GI bleed. Has been suffering since 1998. History of rectal fistula and gallbladder removal. Just finished tapering off Prednisone *YEAH*, Asacol, Questran, Toprol XL (for high blood pressure).

Rider Fan
Veteran Member

Date Joined May 2008
Total Posts : 1445
   Posted 9/5/2008 10:49 AM (GMT -7)   
I think people understand why Jen, but it's still risk/benefit. 240 people is not alot considering how many people are receiving these types of drugs around the world.
Dx'ed in 1999. No surgeries.

Current meds: 75 mg 6MP. 3mg prednisone (trying to taper). Udo's Choice Probiotics (30 billion).

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