Remicade causes severe fungal infections | Arthritis Information

 

...according to DrugSettlement tort attorneys:
http://www.1888pressrelease.com/drugsettlement-com-attorneys-investigating-reports-of-histop-pr-76009.html



1888 Press Release | Archive News | Legal News | DrugSettlement.com Attorneys Investigating Reports of Histoplasmosis Related to Remicade
02
OCT
2008     DrugSettlement.com Attorneys Investigating Reports of Histoplasmosis Related to Remicade
DrugSettlement.com attorneys report that the drug companies only informed the public of 1% histoplasmosis cases known to be associated with Remicade.



New York, NY (1888PressRelease) October 02, 2008 - DrugSettlement.com attorneys have uncovered information that shows that the drug companies may have informed the public of only 1% of the histoplasmosis adverse events related to the use of Remicade. Histoplasmosis is a potentially fatal fungal infection that has been responsible for many deaths.

Remicade (Infliximab), developed by Centocor, a pharmaceutical company owned by Johnson & Johnson, is a drug used to control inflammation due to auto-immune disorders. It has been approved by the U.S. Food and Drug Administration for for the treatment of psoriasis, pediatric Crohn's disease, ankylosing spondylitis, Crohn's disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

On September 4, 2008 the FDA "announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died."

In the press release that accompanied the announcement the FDA reported that the had reprts showing that 240 users of TNF-blockers were found to have contracted a fungal infection called histoplasmosis. Remicade was involved in 207 of the cases.

Histoplasmosis is a fungal infection that exhibits symptoms similar to the flu. It is most prevalent in states bordering the Ohio River valley and the lower Mississippi River.

Unless an individual's immune system is suppressed the fungus remains asymptomatic. However, the immune systems of patients taking TNF-blockers, like Remicade, are suppressed as a result of therapy. This increases their risks of contracting this deadly fungal infection.

In patients who are immune suppressed, most have respiratory complaints like cough or shortness of breath. Others complain of unusual weight loss, fatigue and fevers. Their have also been reports of sores on the skin, bone sores, sores in the mouth or intestines and in some instances neurological complaints.

If untreated, these fungal infections can be fatal in as little as three weeks after symptoms were observed.

What is most shocking is that the manufacturer and distributer of Remicade have consistently issued vague reports of the total number of histoplasmosis cases that they were aware of. For example, the label for Remicade only reports having information concerning two cases. The FDA found 207 cases of histoplasmosis associated with Remicade, while Johnson & Johnson and Centocor reported only 2 cases.

DrugSettlement.com will continue to provide information as it becomes available.

Our attorneys are currently investigating claims on behalf of victims and their families, for those who died or who suffered from fungal infections or cancer following the use of these medications. If you or a loved one has suffered an injury or any of the side effects listed above while taking these drugs, make sure to contact the experienced, and knowledgeable DrugSettlement.com lawyers at http://drugsettlement.com

I've posted about this before.  Here is a Histoplasmosis Fact Sheet.   It is important to note: Histoplasmosis is an infectious disease caused by inhaling spores of a fungus called Histoplasma capsulatum. Histoplasmosis is not contagious; it cannot be transmitted from an infected person or animal to someone else.   Below is a partial list of occupations and hobbies with risks for exposure to H. capsulatum spores. Appropriate exposure precautions should be taken by these people and others whenever contaminated soil, bat droppings, or bird manure are disturbed. Bridge inspector or painter Chimney cleaner Construction worker Demolition worker Farmer Gardener Heating and air-conditioning system installer or service person Microbiology laboratory worker Pest control worker Restorer of historic or abandoned buildings Roofer Spelunker (cave explorer) http://www.cdc.gov/niosh/97146eng.html

AND..............

Just a little more info.......

 

Histoplasma capsulatum is primarily found in the temperate regions of the world and is the most common fungus in the United States. It's endemic in the Ohio, Missouri and Mississippi river valleys, where the great majority of people have been exposed.

The fungus thrives in damp soil that's rich in organic material, especially the droppings from birds and bats. For that reason, it's particularly common in chicken and pigeon coops, old barns, caves and parks.

Birds themselves aren't infected with histoplasmosis — their body temperature is too high — but they can carry H. capsulatum on their feathers, and their droppings support the growth of the fungus. Birds commonly kept as pets, such as canaries and parakeets, aren't affected. And although bats, which have a lower body temperature, can be infected, you can't get histoplasmosis from a bat or from another person.

Instead, you develop histoplasmosis when you inhale the reproductive cells (spores) of the fungus. The spores are extremely light and float into the air when dirt or other contaminated material is disturbed. That's why a high number of cases occur in farmers, landscapers, construction workers, spelunkers and people living near construction sites.

 

http://www.mayoclinic.com/health/histoplasmosis/DS00517/DSECTION=causes

I'm not sure what your point is, Lynne. Are you saying that because people can get it from other things that Remicade does not significantly increase the risk of people developing fatal histoplasmosis? Or that the drug companies did not purposely suppress information about the number of people who developed Remicade associated histoplasmosis? Please explain.


Gimpy-a-gogo2008-10-07 03:42:40I think her point is that Remicade is safe, that you only get fungal infections while on Remicade by breathing the spores.  Isn't that like saying standing inside a fire is safe as long as you don't let the flames get on you? The spores are common but don't affect most people. You can't really avoid them in places where they are prevalent. It's the immunesuppressing quality of the Remicade that makes you suseptable to it.

"Histoplasmosis is a fungal infection that is endemic to rural or farming areas. It is carried in the excrement of bats, It is most prevalent in states bordering the Ohio River valley and the lower Mississippi River. ( Positive histoplasmin skin tests occur in as many as 80% of the people living in areas where H. capsulatum is common, such as the eastern and central United States. )

Unless an individual's immune system is suppressed the fungus remains asymptomatic. Patients administered TNF blockers like Remicade and Enbrel have suppressed immune systems as a result of therapy."

Also, the press release cites that " 240 users of TNF-blockers were found to have contracted a fungal infection called histoplasmosis. Remicade was involved in 207 of the cases." That high a percentage linked to Remicade would indicate that Remicade in particular of the TNF blockers puts patients at a dramatically increased risk for histoplasmosis.



Apparently there are lots of meds consumers should be concerned about.... What are Unsafe Drugs?
Thousands of Americans are seriously injured and die every year from adverse reactions and side effects associated with prescription medications. Drug manufacturers have a responsibility to market drugs and medications that are safe for use by consumers. The Federal Drug Administration (FDA) is the agency responsible for approving prescription drugs before they are sold to the public. However, even FDA approved drugs may still cause harmful side effects not yet recognized during the approval process.

Drugs that May Be Considered Unsafe
The following is a list of prescription drugs that may be considered unsafe: Go-Go, I guess maybe Lynn is agreeing that any medication can hurt or harm the patient.  personally I think lawyers trying to make a buck on suing are as reliable as the drug companies themselves.  Give me data from someone who doesn't have an agendaWhat I haven't seen is info about how to spot a histo infection before it gets bad...is it sub-clinical, or are there warning signs?Katie I posted this before (from the CDC):
http://www.cdc.gov/nczved/dfbmd/disease_listing/histoplasmosis_gi.html#2

"Can anyone get histoplasmosis?

Yes. Positive histoplasmin skin tests occur in as many as 80% of the people living in areas where H. capsulatum is common, such as the eastern and central United States. Infants, young children, and older persons, in particular those with chronic lung disease are at increased risk for severe disease. Disseminated disease is more frequently seen in people with cancer, AIDS or other forms of immunosuppression."

Suzanne2008-10-07 10:28:46Thanks Buckey for posting that 'what to look for' info.  I'm copying that for my files.  Like I want to worry about that too.  Pics of the lesions - Ack!  I have heard about this before and I just checked out the web site on the symptoms and well, gee, I have every one of those most every day!  I guess I am even more at risk since I live in southern mi close to ohio and I have a chronic lung disease and I am on a high dose of remicade!  I wonder if taking nystatin, an antifungual medication, helps to decrease my risk?  The remicade causes me to have chronic yeast infections so I take nystatin twice a day.

I do have to say that remicade is the ONLY drug that has given me any sort of relief at all so I am not likely to give it up for something that MIGHT happen.
[QUOTE=micheleb]

I do have to say that remicade is the ONLY drug that has given me any sort of relief at all so I am not likely to give it up for something that MIGHT happen.
[/QUOTE]

I don't think anybody would stop a med that was working, but I think it is important that when news like this comes out, people know about it.  When it first came out, the article said that some of the people who died would have lived it they had been diagnosed and treated soon enough.  That is why it bothers me when, in my opinion, people try to downplay the risk of coming down with something like this.  It might not be common, but it is in the news because it is happening.
I'm curious as to why folks aren't pointing out that this is a press release from an ambulance-chasing firm.  Many people here get hot and bothered when press releases from Big Pharma are posted. I agree, people should be educated on the possible side effects of the drugs they are taking.  It just makes it hard when the possible side effects cause the same thing that we are taking the drugs for in the first place!  LOL!  How are we supposed to know if we are just in a bad flare or if we have contracted some fungus and its about to kill us?


[QUOTE=JasmineRain]I'm curious as to why folks aren't pointing out that this is a press release from an ambulance-chasing firm.  Many people here get hot and bothered when press releases from Big Pharma are posted. [/QUOTE]

I already knew about the histoplasmosis story; if these ambulance-chasers prove that the actual number of cases was hidden as they allege.....hmm, something to keep your eye on.
[QUOTE=micheleb]I agree, people should be educated on the possible side effects of the drugs they are taking.  It just makes it hard when the possible side effects cause the same thing that we are taking the drugs for in the first place!  LOL!  How are we supposed to know if we are just in a bad flare or if we have contracted some fungus and its about to kill us?


[/QUOTE]

Fever! 
I have sarcoidosis, my temp runs 99-100 every day, I have chronic cough, joint pain, fatigue, etc....a lot of the same things many of you guys have, that's why I was wrongly dx with ra for so long.  I get a few added bonuses like the cough, breathing problems, fever, heart arrhythmia's, etc......Both ra and sarc are really crappy diseases.  Too bad that fungus didn't make us turn purple or some other obvious sign so we can know for sure instead of the info just sitting in the back of your mind making you wonder! 

I am curious to know if the nystatin gives me any extra protection against it, guess I have some googling to do!

I agree, hard to know how much faith to put into the info you get from ambulance chasers but since the fda did make them change the black box warning, there must be something to it.
Damn - I was going to comment on the Ambulance Chasing PR but forgot!  And I agree, it definitely makes the info more suspect.  The only thing that caught my eye is the numbers.  If they are right, and its not being acted upon...if they are 'fear mongering' there should be some sort of huge fine.  Law firms hate fines and ... [QUOTE=JasmineRain]I'm curious as to why folks aren't pointing out that this is a press release from an ambulance-chasing firm.  Many people here get hot and bothered when press releases from Big Pharma are posted. [/QUOTE] michele [QUOTE=buckeye][QUOTE=JasmineRain]I'm curious as to why folks aren't pointing out that this is a press release from an ambulance-chasing firm.  Many people here get hot and bothered when press releases from Big Pharma are posted. [/QUOTE]
[/QUOTE]

I noticed that too, since I'm the one that posted it, and that's why I prefaced it with "...according to DrugSettlement tort attorneys:"

The reason I posted it is because there is an article about it in the Journal of American Medical Association, but I was unable to read it because it's a pay subscription site, so when I googled for more information I came across this one from the attorneys. I thought it was interesting that they allege the makers of Remicade puprosefully mislead people about the rates of Remicade associated histoplasmosis incidents.

All the information, however, can be corroborated by independent sources, for anyone who cares to google, or check out these links. Unfortunately most of the cohesive information articles are from subscription sites so there's only access to the preambles, but they do contain the relevant information. There are all kinds of secondary sources for this information (google: Remicade histoplasmosis), but I posted the attorney press release because it was the most inclusive. (And attorneys usually don't actually lie about anything because it destroys their credibility and weakens their case. IMO, anyway, but feel free to argue that to your heart's content)

Corraborative articles:

http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1834261&contentType=sentryarticle&channelID=30
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1834261&contentType=sentryarticle&channelID=30

Commentary letter from a doctor:
http://www.dailycomet.com/article/20080913/LETTERS/809130267/-1/living&title=Arthritis_drugs_under_scrutiny

Etc, etc:
http://www.chicagodefender.com/article-1841-fda-orders-stronger-.html

Untreated histoplasmosis is fatal. There are also incidents of Remicade reactivating past histoplasmosis. I think, while people may choose to use these drugs, there should be full disclosure of the risks.

And as Lynne always says, we're all entitled to our own opinions. From the US institutes of national health (eye division) website:

In the United States, the highest incidence of histoplasmosis occurs in a region often referred to as the "Histo Belt," where up to 90 percent of the adult population has been infected by histoplasmosis. This region includes all of Arkansas, Kentucky, Missouri, Tennessee, and West Virginia as well as large portions of Alabama, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Mississippi, Nebraska, Ohio, Oklahoma, Texas, and Virginia. Since most cases of histoplasmosis are undiagnosed, anyone who has ever lived in an area known to have a high rate of histoplasmosis should consider having their eyes examined for histo spots.


http://www.nei.nih.gov/health/histoplasmosis/I've had histo and never knew it.  The scarring was noticed in my lungs by my Georgia rheumatolgist in a chest x'ray.  I had just moved there from OhioI should clarify that untreated histoplasmosis CAN be fatal in immune compromised patients such as people using TNF blockers, particularly Remicade. The average person with a healthy immune system may never know they've had it.

However, someone like Buckeye who knows they have had it in the past should be aware that Remicade may reactivate the fungal infection, possibly leading to death in a worse case scenario.I did remicade I was at 10mg/kg at 4 wk interval.  The highest dose and shortest interval allowed...luckily nothing happenedBuckeye - Pip...no idea. I only posted that thing from the eye health site because it had a concise list oh high risk histoplasmosis areas.[QUOTE=Pip!]Buckeye - [/QUOTE] Lesions kind of like acne scars are left in the lungs from where the histo spores attach.  Seeing those scars on x'ray are often the only evidence anyone has had the idea. Ok, I'll worry about this one too.  LOL  I was here for over a decade before I was there.  Do you think I should ask for testing because whatever I have is resistant to most antifungals? the scars dont cause any problems  the scars are very small surface lesions.  there is no residual lung damage for the people who have simple histoplasmosis OK, I'm seeing him soon, I'll take the two things in and see what he says.  He has his own lab so it can't be that hard. Pip!2008-10-07 17:51:04I heard about this too. All of the biologics. I think I should stay uninformed. All these meds are scary and it seems rididiculous in my present condition that I even consider the side effects. I have a huge concern I will die before the housing prices turn around because my brother loaned me 50K for this house and if it does not keep its value and I die, he will lose a lot of money. I also do not know if I am the best caretaker of Kelsey but she wants to stay with me and I do not want her back in an institution. So, even though I fear death less and less, I want my brother and Kelsey to not lose by my dying. So I need to ignore all of these warnings if I want my body to get any better.That's crazy.

Every medicine has risks and benefits.
Well, I feel a bit better knowing I live further north than the major break out area's!  When they did my mediastinal biopsy of my lungs last year, they did culture for fungus and no fungi grew. (Should fungus and fungi be switched in that sentence?) I also had a FULL blood work panel, can we say 13 vials at once, just to test for fungus, bacteria and other crazy little critters by an infectious disease doc last January.

Scaring on the lungs can cause damage if there is enough of it.  I do not know what sort of damage this particular fungus is capable of but sarcoidosis can cause enough scarring to require lung transplants.  I have a fair amount of scarring already and have lost about 15% or so of my lung capacity from it. 

It appears the remicade is keeping the granuloma's to a minimum now though so hopefully I won't have any further scarring!  I look at getting remicade as a quality of life thing-it makes my quality of life substantially better, if it takes years off the top of my life, so be it-I'd rather live better and be able to enjoy what I do have.  I think thats a good why to look at most any drug we may be faced with taking!  Just my opinion though.  But I also agree that the drug companies should not be allowed to withhold information.
Roxy and Michelle -

Sometimes things come from left field, prepared or not. 

Do you have a picture of the spot you could post?  My baby has something that will not go away and we even took her to the doc in October because I was sure it was Scleroderma.  I was wrong, Thank God, but since she has vitilgo, I'm concerned. Pip, I didn't take pictures.  I was ready to if this last Dr. at UWA said it was psoriasis. Sorry.  My leg looked like Google images of psoriasis.  Very red, flaky, inflammed looking and kept growing.  By the time I got a correct diagnosis it had spread and was 8"X10" - quite large and ugly.  I wore long pants, couldn't go swimming, etc.  I was really depressed and had a lot of angst about it.  LindyThis is one small brown dot.  It doesn't grow or change.  It looks kind of flaky but that's about it.  Nothing like I had.  Didn't start that way either.  Might just be pigmentation.  LindyI believe the original notice for this was for doctors to test for it. The people who got seriously ill and died did because they did not get treatment. Its easily treated if caught early.

240 people out of millions on TNFs seems a small thing. Just insist on getting checked.I think the worry is that they're saying one or two people and they lawyers have found more that were told to the FDA and the FDA did nothing about it.  Frankly, I think this is nothing compared to c. diff and the biologics.  Again, knowledge is power and we need to know.  Is that going to stop us from taking our meds?  No.  But if we knew what could happen then at least we're prepared.  Oddly, reading the 'new' LATimes (12/07) this is one of the articles on Valley Fever - Drrr....I can never read NYTimes articles because my registration never works.
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