The Food and Drug Administration ordered stronger warnings about the risk of potentially deadly fungal infections on four medications widely used to treat rheumatoid arthritis and other serious illnesses. The FDA has received 240 reports of patients taking such drugs as Cimzia, Enbrel, Humira, and Remicade, known as TNF-alpha blockers, who said the drug lowered the body’s defense to infections. Overall, 45 patients died. They developed histoplasmosis, a fungal infection which spreads throughout the body.

The drugs work by suppressing the immune system to keep it from attacking the body and they are approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and Crohn’s disease. But the treatment can leave patients vulnerable to other complications, or diseases.

“FDA has asked the manufacturers of these four drug products to highlight existing warnings of fungal infections,” Dr. Jeffrey Siegel, clinical team leader at the FDA…He added that the box warning must be upgraded to “strongly warn doctors to consider the occurrence of histoplasmosis and other fungal infections.”

The agency is also investigating a possible link between the four medications and cancer in young patients. The FDA had received 30 reports of cancers, mainly lymphomas, in patients who began taking the medications when they were 18 or younger. The agency said it has a six-month timeline for the review. “We intend to meet that timeline,” Siegel said.

Scary stuff. Once again, you have to question the thoroughness of FDA pre-release testing.




  1. bobbo says:

    So, the numerator is 240 and the denominator is unknown?

    Immune suppressors are all dangerous as every breath of air, every inch of skin contains fungus, mold, and who knows what else.

    Our immune system evolved to keep us alive ala “War of the Worlds.” Suppressing it really is dangerous. Cancer patients often take “broadband anti-biotics”–kill every to get at the cancer and you die from other stuff your healthy body normally fights off.

    So, yea, make the drug so weak its worthless but safe and a money maker, or effective but requiring a hospital stay for monitoring which even the best healthcare system in the world can’t afford.

    Or==be informed, and make your choice or risks.

  2. ECA says:

    I have an EYE DROP, my doctor just started me on for 3 months…

    LET me get my +2.00 glasses out and read this.
    5-15% chance..
    POTENTIAL
    Cardiac failure
    Obstructive Pulmonary disease
    vascular insufficiency
    reactivity to allergens
    Muscle weakness
    Masking hypoglycemic symptoms
    masking thyrotoxicosis

    Combigan..

    THIS from an EYEDROP..

  3. ECA says:

    NOW…
    I aint complaining..
    But.
    For a person with eye problems, WOULDNT you think that this would be in a LARGER FONT.
    THIs little sheet of paper in the box, could make a NICE 20 page book.

  4. bobbo says:

    #2–ECA==5-15% chance?? Wow! Didn’t know they allowed euthanasia in the USA. Very progressive state you are in.

  5. gunny says:

    Hey, there’s no such thing as a free lunch. Messing around with your body’s immune system at that level will get you unintended consequences. And as the other posters pointed out, this is all statistical probability anyway — it is not certain you will get any of these other diseases. You pay your money and take your chances.

  6. Jen says:

    Here’s the thing — if you actually read the paperwork they give you before you start taking the medication and have a frank discussion with your doctor about the risks, then you know ahead of time this is a possibility. I’ve been on Remicade for 3 years for polymyositis. It was made very clear to me that taking this drug puts me at a higher risk of infection and I therefore have to be more vigilant about that. Don’t ignore early warning signs. Don’t go in for treatment when you know you’re under the weather. The tradeoff is that I have a relatively normal life. I would guess that most people who are taking it would continue taking it because, in my personal experience, the benefits far outweigh the risks.

    As to the cancer research — the last documentation I looked at said they hadn’t yet been able to determine if the increased cancer risk was due to the diseases being treated in the first place or due to the drugs used to combat them.

    I’m all for safe drugs, but if you are suffering with a rare disease for which there is little to no research dollars, there aren’t many options for treatment. the next alternative for me would be total immuno-suppressive drugs (like what they give to transplant recipients) — also expensive, and they come with their own set of not great risks and long term complications.

    i think the real key is to be an informed patient. Make your doctor take the time to discuss options and risks before you start treatment so you knwo what you’re getting in to.

  7. Floyd says:

    Histoplasmosis is a fungus that is endemic to the West, Midwest, and Southern US. Most people who grew up there already have immunity to it. However, if this drug suppresses that immunity, it could be a real problem in that part of the country.

    It’s a tough choice–let your body destroy itself (that’s what arthritis and other autoimmune diseases do), or be attacked by histo and other such diseases.

  8. Ron Larson says:

    In other shocking news, the Dept. of Transportation reports that every time you drive your car there is a chance of serious injury or death. Last week alone in the US more than 200 people were injured. So please people, don’t drive.

    Also, the FAA reports that over the last ten years, some people have died as a results of airline crashes. These accidents are usually fatal. So please people, don’t fly.

    The AMA reported that dozens of Americans have died from choking since they started tracking it. So please people, don’t eat.

  9. bobbo says:

    #8–Ron==so you’re saying the long term side effects/risks are as well known and obvious as those attendant to driving a car?

    Really?

  10. Eric says:

    I suffer from Psoriasis, and was just prescribed Enbrel on Wednesday. Thank GOD I read this article today, as I was about to head on down to the blood bank to get tested to make sure that I can take this drug. Lung fungus is not the only risk to taking this type of drug, so are various types of cancer, and a few other problems.

    I’ve spent the last 2 days running over the information that I can gather about trying this treatment, and everything that keeps coming back is that the cure might be worse than the disease, which is saying a lot, since the disease is pretty damn bad in the first place.

    Also, and this is the one that pisses me off to no end. There is no cure for what I suffer from. None whatsoever. Just ways to keep it suppressed, not cured, so they get to get us on the comeback for the rest of our natural lives. That’s what it seems medicine has come to. We’re no longer looking for the cure, we’re just looking for the way to keep people alive for as long as possible.

    Which is why the real work in Biology is happening elsewhere in this world, where there’s less incentive to keep people paying, and more incentive to get them to stop paying. Government health care may be controversial here in America, but lets face it, as long as there’s money to be made by keeping people sick through higher premiums and continued medical intervention, there’s no reason for us to ever find another cure again.

    I didn’t start out as an advocate one way or another with regards to health care reform, but I’ll tell you what, when you’re the one who’s sick, your perspective has a tendency to change fast. I’m still not convinced that Government run Health Care is the answer, but damn, I’m certainly starting to see where those that are in favor of it are coming from.

  11. jccalhoun says:

    My mom’s been taking Enbrel for years for Rhematoid arthritis. There’ve been a history of issues with it but it is still the best medicine for her so she keeps taking it.


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