Enbrel Gets "Black Box" Warning | Arthritis Information

 

I think most of us taking enbrel are aware of a risk for infection and a concern for TB.  My rheumatologist recently has started requiring all patients on biologics to have an annual TB test.  With that said, I thought I'd post the following that appeared in today's news FYI:

Biologic Drug's Infection Risk Warning Strengthened to "Black Box" Warning

 

By Miranda Hitti
WebMD Medical News

Reviewed by Louise Chang, MD

May 1, 2008 -- The arthritis and psoriasis drug Enbrel now has a "black box" warning about the risk of serious infections that may lead to hospitalization or death.

Enbrel is used to treat rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. It already carried a warning about infection risk. Now, those risks appear in a "black box" warning, the FDA's sternest warning.

The new black box warning notes that infections seen in patients treated with Enbrel have included bacterial sepsis and tuberculosis. The warning recommends teaching patients taking Enbrel about infection symptoms, monitoring them for infection during and after treatment with Enbrel, and screening them for tuberculosis before and during Enbrel treatment.

Amgen and Wyeth, the drug companies that make Enbrel, wrote a letter to doctors in March to tell them about Enbrel's black box warning. That letter now appears on the FDA's web site.

http://arthritis.webmd.com/news/20080501/enbrel-gets-black-box-warning

 

Well, now I know why the other post was made. Our Ghost Talker told me one was coming. Just scanned the post you were referring to Pip.  Interesting timing, yes, and, responsible too.

 

My name is Joy, and I'm an enbrel user, to borrow from AA intros :-)  (attempt at humor)  I've been on some form of biologic for 6 yrs now and during that time I've been fortunate to have been seldom sick -- no cold, no flu, no infections (knock on wood, my head)  I'm aware I'm on a drug that suppresses my immune system, so I try to counter that by a healthy diet, getting enough sleep, etc.  Plus I'm not out and about in the public much, exposed to all those viruses and bacteria.

 

For me, the choice to go onto enbrel was not taken lightly and it has not excluded consideration of alternative or supplemental treatments.  I think its important to be aware of ALL possible RA treatments, sharing information of risks and benefits and personal experience, may help someone facing the decision of what drug to choose.

      

hi joie i fear as time goes by more results of bioogics will be revealed.
as we allknow the longterm effects of biologics are uknown..
my nurse said they are frightend to give me bioogics due to bad reactions
on other meds.
Boney
does someone have a link to the letter to the FDA?The link below is to an article from a biotech industry website that discusses this.  It states:

Amgen and Wyeth are informing healthcare professionals about the revisions to the U.S. PI through a “Dear Healthcare Professional” letter, and will post the letter and updated PI on www.enbrel.com. Physicians, patients and caregivers who have additional questions may contact 1-888-4ENBREL.

I did a quick check of  the enbrel site but wasn't able to find the letter.  (PI means prescribing information)

 

 http://www.fiercebiotech.com/press-releases/amgen-and-wyeth-announce-enbrel-drug-gets-black-box-infection-risk-warning

 

Excuse my ignorance but does the black box warning mean it is even more likely than previously thought to cause TB? I think it means that the number of TB cases is of concern, therefore warranting the black box warning, not sure if its necessarily an increase as it doesn't mention time periods .  From biotech website:

 

"Other PI updates include the addition of reported incidence of tuberculosis infection observed in clinical studies in the Adverse Reactions section. In global clinical studies of more than 20,000 patients, tuberculosis was observed in approximately 0.01 percent of patients. In more than 15,000 patients from clinical studies in the U.S. and Canada, tuberculosis was observed in approximately 0.007 percent of patients."

 

So, .007 percent of 15,000 is 105 patients.  Something to definitely discuss with your doctor

 and to further research, its hard to evaluate such things on our own.

 

I share your same concern.  I live in California, and there are a lot of people here that travel to India, Russia, and S.E. Asia, areas where TB rates are high.    

 

 

If you are concerned about TB you might think of adding vitamin D to your diet...

Vitamin D might help the immune system fight tuberculosis infection by activating a bacteria-killing protein, according to a study published in the Feb. 23 issue of Science, HealthDay reports. According to Robert Modlin -- head of dermatology at the University of California-Los Angeles' David Geffen School of Medicine -- the immune system can stimulate white blood cells to convert vitamin D into a form used to produce a protein that fights TB bacteria. The researchers also found that blacks -- who are at an increased risk of TB infection and often develop more severe cases of the disease -- have lower levels of the vitamin in their blood, according to Modlin. He added that melanin, the pigment that darkens skin, reduces vitamin D production in blacks because it absorbs sunlight's ultraviolet rays, and vitamin D is produced in large part by exposure to sunlight. The researchers found that cells developed in blood serum taken from blacks produced 63% less of the bacteria-killing protein than cells grown in blood serum from whites. According to Modlin, the cells increased production of the protein when researchers added vitamin D to the cultures. Further studies need to be conducted into whether taking vitamin D supplements would produce the same results, Modlin said, adding that researchers are examining the effects of vitamin D on the immune system (Edelson, HealthDay, 2/24).
  I have been on remicade,enbrel,humeria,ect .  I work in a hospital for 14 yrs. in housekeeping. If we have a isolation with tb i dont go in because of my meds. we also have yearly tb tests. I feel if your on these meds you must educate your self with the info available at the time. i am sure that they dont know all the long term effects and i pray that its nothing bad.If i want a life now i have to take chances with my future...

Yes, I agree with JennyB and Joy -

My doctor is pretty cautious.  Starting last year I have to get a yearly TB test (blood test, not the skin test).  It's also worth noting that the DMARDs and prednisone are also associated with higher risk of TB infection.  Of course, unteated RA also has significant side effects including cardiovascular disease.  Frankly I don't think there are any low risk options. Yes, we have a heck of a disease.  That being said, I want us as protected as possible.  They know about Vioxx 2 years before it was pulled.  They knew about Phen-fen from Europe - but it was still approved here.  How much do you want to bet that Accomplia with a 48% increase in suicide problems STILL gets FDA approval in the states.

Pip,

What is this "we"? We have rheumatoid arthritis. You have palindromic arthritis. The only thing the two have in common is that both cause joint pain. Rheumatoid arthritis destroys joints and erodes bone, palindomic arthritis doesn't. Palindromic arthritis pain may last for hours or even days and then not come back for months and then I guess you "herx". Rheumatoid arthritis pain does not stop and constantly destroys joints unless our wonderful medicines slow the inflamation that destroys the joints and bones. What's your problem with our medicines. We are an informed group of rheumatoid arthritis patients. My doctors (and I would imagine most every ra patients doctors advised them) advised me concerning the risks and benifits of our drugs and we with the crippling disease, rheumatoid arthritis have decided that the benifits outweigh the risks and the crippling. You can't understand that because you don't have a crippling disease. You don't have rheumatoid arthritis. Before I started enbrel I was well aware of the rare chance of sepsis and tb. Even before I read the statement given with enbrel my doctors had discussed it with me, you know, my U of M doctors. They monitor me closely. Lab tests every two to three months. I'm constantly warned about what to watch for and advised to always go to urgent care at the slightest sign of something unusual. They know and I know that I have a very serious disease that has the potential to kill me. They know and I know that I take very serious drugs with very serious possible side effects that must be closely monitored. They know and I know that prior to the new drugs and during the antibiotic years, all ra patients could look forward to was deformed limbs, and excruciating crippling pain but not anymore. You don't even know how dangerous your ap therapy can be. When a bug outwits your minocin, you and the world have bigger troubles than sepsis or tb. When mrsa mutates into a minocin resistant strain, look out world. It's strange that you can forsee all the possible future nagatives with our drugs but yet your drugs can have nothing but a happy ending and all you are doing is presuming, cause you don't know. Let me say it one more time, you don't know, it's that simple, simple stuff, isn't it?

you know when the biologics came out ,i was game on!! get me out of pain an on with life.. It did work for a long time but have slowly come to the end of the bio train.Do i regret ? no way !! i would do it the same because it gave me some time away from the never ending pain an stiffness..mirsa  scares me,cousin is in the ICU 8wks an counting. still fighting for her life at 48..To have confidence in our choice of  drug treatment, we must have access to ALL research findings.  Recent legislation now requires that all clinical trials be available to the public.  The following excerpt is from an article in the National Library of Medicine and Medlineplus.gov website that I have found helpful and you might too:

 

"An analysis finds the U.S. Congress' recent efforts will make more results of clinical trials and results of clinical trials open to the public.

Writing in Science, the authors cite areas of progress including a new requirement that standardized summary results should be available within 12 months of a clinical trial completion, or within 30 days of the FDA's approval of a drug or device.

In the future, the public will have access (for the first time) to basic information about the findings of clinical trials, such as the demographics and baseline characteristics of the trial participants, the primary and secondary outcomes of the study, the statistical analysis used by the investigators, and possible agreements that restricted researchers from disseminating previous results at scientific meetings.

In the past, this information was only available if a trial sponsor voluntarily disclosed the information, such as by publishing it in a medical journal.

The authors provide some recent examples of deficiencies in disclosing information about the safety and effectiveness of a medication -- after approval by the U.S. Food and Drug Administration (FDA). The authors note the Congressional legislation passed in September 2007 will require more openness in providing clinical trial information to the public. So, some future concerns about drug or device safety and effectiveness might be addressed sooner through mandatory disclosure of the results."

For rest of article see:

 

http://www.nlm.nih.gov/medlineplus/podcast/transcript041408.html

 

   

what i was trying to get at with out a speech about access to research ( im sure that is going to bite me)when this all started with biologics there was no long tearm research on side effects..to me it probably wouldnt of mattered. I was looking for a fix for my pain filled life.I guess i will deal with the long term when it gets here.Jennyb - i agree an thats why they black boxed it right? Im saying alot of these meds are now just coming in with long term effects. these are fairly new drugs that came out in the last 10 yrs i believe(not a Quote)..Chomp!  :-) Sorry, Jenny, my post wasn't directed at you, but at an earlier post about info being withheld from the public.  I just wanted to post about legislation that corrected  that.  The article referenced also has a tutorial on understanding the clinical trial process.  I'm sorta nerdy and find this kind of stuff interesting.  End of speech.

 

To get personal, I had had RA for 25 years before I began biologics.  By that time, I had a lot of joint damage, and two knee replacements.  So I totally understand and share your point of view.  I too will deal with any long term effects, consequences of MY decision,.  I hope there won't be, but that was the risk I took for the benefit of stopping further joint damage.     

i too want all info to be accessable . my DD has ra an i want safety for her future..i have had ra for 17yrs an it is relentless.i keep on fighting but some days its damn hard and im  weary...Never give up, you guys.  Never.  There's a way out for everybody.  We just have to find it to heal. thanks pip sometimes i need a cheerleader No tears.  I'm thinking we need our own slogan.  How about that movie with Tom Hanks - A League of Their Own.  Paraphrasing -
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