Black Box Warning for Remicade, Enbrel and Other Rheumatoid Arthritis Drugs about Risk of Fungal Infection
The FDA has issued an alert to healthcare providers about the risk of a serious fungal infection which may develop in users of rheumatoid arthritis drugs Remicade, Humira, Enbrel and Cimzia. The agency indicates that new information will be added to the drugs’ black box warnings about the risk.
The warning applies to drugs that are part of a class of medications known as TNF blockers, which work by blocking a protein called tumor necrosis factor-alpha or TNF-alpha. TNF-alpha causes inflammation, which is a symptom in rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and Crohn’s disease. The drugs act as an immunosuppressant, which could increase the risk of invasive and potentially fatal infections.
All of the rheumatoid arthritis drugs already contain warnings about the risk of infections, which could include bacterial tuberculosis and the fungal infections like histoplasmosis, blastomycosis and coccidioidmycosis. However, the information will now be placed more prominently on the label to make sure doctors and users are aware of the side effects.
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Learn MoreThe FDA indicates that many of the cases involving patients who experienced severe problems were not properly diagnosed at first, and antifungal treatments were delayed. Doctors have been urged to watch for signs of histoplasmosis and other fungal infections, which could include symptoms similar to the flu.
The symptoms of a systemic fungal infection from Remicade, Enbrel, Humira or Cimzia could include cough, fever, fatigue, loss of weight, sweating and shortness of breath.
Over the past decade since the drugs were approved, the FDA has received reports of 241 cases of histoplasmosis in patients using the TNF-blocker drugs, and 45 of those cases resulted in death. In at least 21 cases, doctors did not recognize the fungal infection in time and delayed antifungal treatment, resulting in 12 of the deaths. Most of the cases occurred in the Mississippi River Valley and Ohio River Valley, where the fungus is prevalent.
Users of Remicade, Humira, Enbrel and Cimzia have been asked to call their doctor if they develop persistent cough, fever, fatigue or shortness of breath. Doctors have been advised to monitor their patients on TNF blocker drugs for possible fungal infections and to start aggressive antifungal therapy if needed.
In June 2008, the FDA issued an early communications alert about another possible side-effect of the TNF blocker drugs, involving a number of reports of lymphoma and other forms of cancer among children and young adults. The FDA is conducting an ongoing safety review of those reports, and estimate that it will take about four more months to complete.
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9 Comments
EndoraAugust 24, 2022 at 7:28 pm
I have PsA & AS started on embrel ..next was Concentex next was Humaria & 21 days ago I had my 1st remicade infusion . 3 days later my toes & foot turned ice cold & purple. 2 ER trips 3 Primary trips 1 cardiovascular surgeon and STILL no one knows what's wrong or going on . I can say I have 3 kids who were all natural child birth. The pain I'm experiencing in my foot & toes makes child birth fe[Show More]I have PsA & AS started on embrel ..next was Concentex next was Humaria & 21 days ago I had my 1st remicade infusion . 3 days later my toes & foot turned ice cold & purple. 2 ER trips 3 Primary trips 1 cardiovascular surgeon and STILL no one knows what's wrong or going on . I can say I have 3 kids who were all natural child birth. The pain I'm experiencing in my foot & toes makes child birth feel like a skinned knee !! I have also developed high BP since the infusion.. From what I been finding out Remicade can cause chemically induced neuropathy and its looking like that's what I have & at this rate could potentially lose toes or my foot . I found out there Is a connection with people with AS & PsA who have SI joint issues & this reaction. I don't know I'm not a medical person. All I know Is I wanted to enjoy things with my boys & grandson and I may lose my foot all because I trusted a Dr to help me to feel better
CathyMarch 17, 2014 at 3:01 am
I want everyone to know my husband had been on remicade for at least 7 years, and unknowingly developed lymphoma. He was diagnosed in December of 2013 and passed away 2 weeks ago. He had other health issues but I strongly feel if he were more closely monitored with frequent chest X-rays the cancer might have been caught in time. I am beyond livid at the Dr. who was giving him these injections. I a[Show More]I want everyone to know my husband had been on remicade for at least 7 years, and unknowingly developed lymphoma. He was diagnosed in December of 2013 and passed away 2 weeks ago. He had other health issues but I strongly feel if he were more closely monitored with frequent chest X-rays the cancer might have been caught in time. I am beyond livid at the Dr. who was giving him these injections. I am leary now of all of these "miracle" drugs.
DorothyJuly 16, 2013 at 3:48 am
My husband died dec.31-2012 he was taking remicade he had alot of sideffects from remicade I can see all the sideffects reading his doctor reports I have been trying to find a lawyer to suite remicade have not found one yet just knowing that remicade killed him is just eating my life away he took this drug since 2004 he was never told about the BLACK BOX WARNINGS if anyone knows about a lawyer tha[Show More]My husband died dec.31-2012 he was taking remicade he had alot of sideffects from remicade I can see all the sideffects reading his doctor reports I have been trying to find a lawyer to suite remicade have not found one yet just knowing that remicade killed him is just eating my life away he took this drug since 2004 he was never told about the BLACK BOX WARNINGS if anyone knows about a lawyer that could heip me please let me know if anyone is considering this drug Iam warning you please DONT
Seattle GirlOctober 5, 2012 at 3:31 am
Remicade killed my mother. All the warning signs were ignored by doctors, specialists, neuorlogists for years...in fact, none of them even seamed to be aware of the warning signs and blackbox warnings. October 1, 2012 was the one year anniversay of her memorial. If you are considering this drug, please do your research and read the testimonials.
JamesMarch 30, 2012 at 6:02 am
I was injured on the job(UPS) on May 5th 2000. Back injury that was not surgically correctable. As my COBRA heath insurance was about to run out, I decided to use my remaining health insurance to help me with a chronic problem, Psoriatic Arthritis. I found a Doctor in my home town who was willing to start me on Embrel quickly. I took the twice weekly injections for five months, July 2004 through [Show More]I was injured on the job(UPS) on May 5th 2000. Back injury that was not surgically correctable. As my COBRA heath insurance was about to run out, I decided to use my remaining health insurance to help me with a chronic problem, Psoriatic Arthritis. I found a Doctor in my home town who was willing to start me on Embrel quickly. I took the twice weekly injections for five months, July 2004 through Nov. 2004. In July of 2005 I became extremely sick with chronic meningtis I presented at the local health center and was not cured. I then traveled to University Hospital in Tucson AZ and presented my horrible brain damaging meningtis to the excellent staff there. The ER doctor asked if I had been tested for "valley Fever", a common name for Coccidioidmycois, a common fungal diease here in centeral AZ. I spent 11 days at University Hospital while they waited for the fungus spores to develop. I was treated with massive doses of Fluconazole, an anti-fungual medicine. I also received powerful pain killers to help cope with massive inter cranial pressure I was suffering from. I was told that I had "Deseminated Coccidioidmycois, a rare form of "Valley fever that had no cure, and I was instructed to take 800 mg of Fluconazole daily to help prevent flare-ups of the meningitis. Since then I have suffered everyday with massive blind-siding headaches that have no end. One doctor told me that the Embrel treatments brought my immune system way down and I was unable to fight off the coccidioidmycois, which in my case went extra-pulmaniary and attacked my central nervous system instead. I feel that the makers of Embrel did not complete the warnings section of their new drug, which had NO warnings about possible fungus infections, although I see these warnings now on the labeling.. I feel that "fast-tracking drugs has left me an extremely sick man, unable to lead a normal life syle and robbed of my health and putting me at death's doorstep. Respectfully submitted, James L Berry
MarieApril 17, 2010 at 3:49 pm
I have Chrones discease. Just have a problem with bloting in the small intestins.No pain, no vomiting. Bowel movments once a day, (in the morning with coffee and a ciggerett). My doctor told me that he was putting me on Cimszia. I left his office with a pamplet to read. He said he would get approval from my insurance, and order the cimszia right away. I read the info from the company, then I went[Show More]I have Chrones discease. Just have a problem with bloting in the small intestins.No pain, no vomiting. Bowel movments once a day, (in the morning with coffee and a ciggerett). My doctor told me that he was putting me on Cimszia. I left his office with a pamplet to read. He said he would get approval from my insurance, and order the cimszia right away. I read the info from the company, then I went on the computer. I called my doctor, and informed him that I was not comfortable taking this dangerous medication. He tried to intiminate me into agreeing to taking it. He told me that it was approved by my insurance, and ordered. I then ask the one important question that made up my mind. That question was -- how long would I be on this Medication .... 3 months? six months? how long? He told me that it would be a lifetime medication.My insurance got a call from me letting them know that I refused this Cimszia. I told them that, in my oppinion,It was a very dangerous drug. The insurance company thanked me for the call and said they would cancel the order. I quickley told him that there was no way that I would take that. I"m in great shape compared to all the reserch I"ve been reading. Just the other day I was running around, playing with my 3 year old grand daughter. I have an active life. I am not ready to lay down to this medication. I wonder if some docs are pushing these blockers that are so dangerouse. I will be seeing my doctor in a month for my checkup. If he has an aditude, I will change Docs, and I have been with this doc since 1983. That is how strong I am against this medication.
StanApril 10, 2010 at 3:17 am
Enbrel was my first drug with not much sucess. Started taking Remicade in 2005 for RA started with 300 mg and in Sept. 2008 I was at 900 MG when hospitalized for severe abdominal pain small particle intestinal blockage taken off Remicade placed on Humira (Oct. 2008) within 4 weeks increase to every week injections hospitalized March 2009 with three blood clots in left leg started taking warfarin [Show More]Enbrel was my first drug with not much sucess. Started taking Remicade in 2005 for RA started with 300 mg and in Sept. 2008 I was at 900 MG when hospitalized for severe abdominal pain small particle intestinal blockage taken off Remicade placed on Humira (Oct. 2008) within 4 weeks increase to every week injections hospitalized March 2009 with three blood clots in left leg started taking warfarin until just about a month ago when I was taken off to start radiation and chemo. In December 2009 underwent surgery to remove two-third of the right side of my tongue due to Squamous Cell Carinoma have started radiation and chemo which I am now hospitalized at this time from a very severe burned mouth.and a yeast infection with a white blood count of 1.1 thats good compared to the 0.8 that prompted my being admitted. Have lost 13 pounds in two weeks and I am still required to undergo another five weeks. Can't imagine what I will be like then or if I wil be alive. Becareful a small open sore can be danagerous and maybe fatal and can very quickly develop into cancer while using these drugs. Words of wisdom weight the disease effects vs the drug effects to treat the disease. If I had it to over I would suffer the RA effects.
LewisMarch 30, 2010 at 11:16 pm
I took Remicade, Enbrel, and Humira for RA. In February 2005 I was diagnosed with monoclonal protein in my blood. Then, on March 8, 2007, I was diagnosed with Non-Hodgkin's Mantle Cell Lymphoma. I began taking the drugs before Johnson and Johnson, i.e. Centocor, Abbott, and Amgen/Wyeth announced that TNF Inhibitors could cause Lymphoma. Upon diagnosis, I was given 6 months to live; however, I ha[Show More]I took Remicade, Enbrel, and Humira for RA. In February 2005 I was diagnosed with monoclonal protein in my blood. Then, on March 8, 2007, I was diagnosed with Non-Hodgkin's Mantle Cell Lymphoma. I began taking the drugs before Johnson and Johnson, i.e. Centocor, Abbott, and Amgen/Wyeth announced that TNF Inhibitors could cause Lymphoma. Upon diagnosis, I was given 6 months to live; however, I had a Stem Cell Transplant on August 27, 2007, at Wake Forest Medical Center, Winston-Salem, NC. I continue to take Chemo for this deadly disease. My last CT Scan did not show any tumors in his abdominal area. Our family has been and are still going through a nightmare over these drugs. All RA victims need to be aware of what these TNF Inhibitors can do to them. The doctor knows these drugs caused deadly Lymphoma in my husband. Remicade, Enbrel, and Humira are KILLER drugs. This is not fiction; this is a man's life. One life is One too many
anastasiaNovember 9, 2008 at 2:24 pm
I tried remicade with 2 treatments for crohn's disease and inflammatory arthritis, after 2 days I had severe vertigo,unsteady gait,ringing b/l ears.It has now been over a year and after several doctors I have now been dx with dystonia. My legs are horrible weak and can;t walk any distance and my posture is bent,if I try to stand up straight I fully spasm and fall. I've seen 3 neuro and all thought[Show More]I tried remicade with 2 treatments for crohn's disease and inflammatory arthritis, after 2 days I had severe vertigo,unsteady gait,ringing b/l ears.It has now been over a year and after several doctors I have now been dx with dystonia. My legs are horrible weak and can;t walk any distance and my posture is bent,if I try to stand up straight I fully spasm and fall. I've seen 3 neuro and all thought it was ms, had lumbar punture,vep and multiple brain mri that are normal. I had never had a problem with vertigo etc. until after receiving remicade. I currently am in a wheelcair,lost my job and often think what if I didn't do remicade if my life would be normal per say. I may know I have chrons small bowel and arthritis but I worked very well and managed it,we did the remicade because the sacroliac joints are so painful it was ahrd to get up and down,sleep with no pain etc. Now I have horrible pain still but all these new problems. I have been told by so many people they still think it is ms and would love to know if remicade could cause an early ms. My mri of thoracic showed benign hemanigoma and arthritis,my lower back has rheumatoid spondolitis,toracic showed enchancement also in a certain area,what are the possibitiy that this is an early ms with dystonia. I've worked in the medical feild 16 years,my family are all in the medical feild and still wonder also if this is a case of ms that presents oddly because of remicade. So many symptoms of ms it's scary.