FDA warning re biologics and cancer risk

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Veteran Member

Date Joined Mar 2006
Total Posts : 1169
   Posted 8/5/2009 9:46 AM (GMT -7)   
For those on Humira, Remicade and other TNF drugs:

FDA Warns of Pediatric Cancer Risk with TNF Blockers

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By Cole Petrochko, Staff Writer, MedPage Today
Published: August 04, 2009

WASHINGTON -- The FDA called for stronger warnings in prescribing information for tumor necrosis factor (TNF) blockers to highlight a greater risk of cancer in children and adolescents.

The updated black box warning requirement arose from FDA analysis that showed an increased risk of lymphoma and other cancers -- particularly in younger patients -- with this class of drugs, which includes:

  • Infliximab (Remicade)
  • Etanercept (Enbrel)
  • Adalimumab (Humira)
  • Certolizumab pegol (Cimzia)
  • Golimumab (Simponi)

These drugs are commonly used to treat chronic inflammatory diseases, including Crohn's disease, rheumatoid arthritis, and juvenile idiopathic arthritis. They block overproduction of TNF-alpha, which can cause inflammation and damage to bones, cartilage, and tissue.

While previous safety labeling on TNF blockers included a warning for malignancies, it did not specifically mention leukemia. The labeling has also been updated to reflect the danger of new-onset psoriasis in patients on these drugs.

The FDA was aware of a possible risk of cancer in all patients taking TNF blockers and of lymphoma in children and young adults as early as 2006. It started an investigation in June 2008, after it received 30 reports of children under the age of 18 developing cancer.

Its review disclosed that the increased risk of cancer occurred after 30 months of treatment on average, with about half the malignancies being lymphomas. Most affected patients were also on other immunosuppressive medications with lymphoma risk.

The review suggested elevated risk with infliximab and etanercept, though there was little data for the other TNF blockers.

In late June 2009, a study of the TNF blocker golimumab in patients with refractory rheumatoid arthritis revealed no short-term safety issues, including cancer, despite concerns about the drugs' ill effects. (See Golimumab Treats RA When Other TNF-Alpha Inhibitors Fail)

The FDA recommended that physicians discuss these risks with families and monitor for malignancies during and after TNF blocker treatment and to monitor for new or worsening psoriasis during treatment.

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Veteran Member

Date Joined Jan 2006
Total Posts : 3143
   Posted 8/5/2009 9:59 AM (GMT -7)   
Hmmmm....won't say more for fear of starting controversy. Glad you posted this. It makes me more resolute in my current position on the meds for my own self.
Dx'd '90 (emergency rupture), symptoms ignored long before that, '03 fistulas and bad flagyl reactions, B12 weekly, Pentasa [until I surrender to the bigger meds]
I'm riding on the escalator of life....

Regular Member

Date Joined Jun 2009
Total Posts : 202
   Posted 8/5/2009 10:07 AM (GMT -7)   
Had the same information sent to me via e-mail from the IGuard RX program I'm part of.  Good information.  However, it does pertain to "children & adolescents" and since I'm neither one of those, I'm not going to let it stress me.  I trust my GI doc to do what's in my best interest.  She's the best!!

Crohn's Disease. 
Diagnosed 13+ years ago. 
Been in remission for short periods of time but each time I come out of remission my disease seems to have spread.  No longer isolated in my ileum, now from stomach down to rectum. 
Current Medications for the Crohns:  Humera 40mg injections every other week, Imuran 150mg, 3xday, Hyomax, Welchol 625mg, Flagyl 250mg, 3xday, Calcium, Acidophilus & Potassium
Previous Medications I've been on:  Asocal, Pentasa, Cipro, Prednisone & Entocort

Veteran Member

Date Joined Mar 2006
Total Posts : 1169
   Posted 8/5/2009 1:30 PM (GMT -7)   
I agree. From the data noted here it would seem that the cancer risk is still minute. The FDA is sometimes notorious for going overboard on product warnings. I am still of the opinion that ne's risk of lymphoma is probably greater from uncontolled Crohns inflammation over time.

Veteran Member

Date Joined Mar 2006
Total Posts : 2739
   Posted 8/5/2009 1:45 PM (GMT -7)   
This is a concern for me, if I ever am in need of such medications. We've already got Lymphoma in our family, including my own Mother. So I am naturally concerned if this would increase my risk further.
Diagnosed with Crohn's Disease 2/06, and Health Anxiety/OCD 12/08 Taking Asacol, Questran, Toprol XL, and Celexa.

Elite Member

Date Joined Sep 2005
Total Posts : 10404
   Posted 8/5/2009 2:34 PM (GMT -7)   
Mike, could you please edit your post so that it contains just a link to the relevant article?

It is a waste of expensive forum resources to cut and paste information from another website, and you also risk breaching copyright laws.

Thanks... and thanks too for the information,

Co-Moderator Crohn's Forum.

Medications for Crohn's ~~ Diet and Nutritional Therapy for Crohn's

Regular Member

Date Joined Jan 2009
Total Posts : 209
   Posted 8/5/2009 3:31 PM (GMT -7)   
I'm with you 100%!
No Remicade,no remission for me.
B-12injections,Pentasa,Loperamide,Entocort,6mp,Hydrochlorothiazide,8 week
Remission since surgery
and 8-week Remicade.

Veteran Member

Date Joined Dec 2005
Total Posts : 1768
   Posted 8/5/2009 3:46 PM (GMT -7)   
I agree with Mike B...I would worry about the damage caused long term not treating my CD and having to use steriods because of obstructions that Humira has kept at bay for 2 years. Of course there are risks associated with any meds, and you have to weigh the risk vs benefit.

31 yr old female-dx with Crohn's in '97 after emergency resection and appendectomy, 2nd resection '05
Currently on Humira, Prilosec, Effexor, Seroquel, Calcium, Vit D, sublingual B12; phenergan, ultram, clonazepam as needed

Regular Member

Date Joined Aug 2009
Total Posts : 31
   Posted 8/9/2009 10:18 PM (GMT -7)   
Look at the side effects that prednisone causes....If you look at the over all picture prednisone is the worse on of all! Isn't the risk for the tnf's like 1 in 10,000? Risk vs Benefits is what we all have to face with these medicines.

Veteran Member

Date Joined Sep 2006
Total Posts : 845
   Posted 8/10/2009 12:21 AM (GMT -7)   
Well, I have used 3 of the 5 on the list and still cancer free. Does this mean that I won't geti t in the future? Of course not, but I am not going to worry about this new warning. In fact, it is not a new warning at all to those of us that have used these medications in the past or currently. It is clearly marked on every box and the doctor or nurse that was administering the medication let you now the warnings and possible side effects. Sometimes you have to take a chance for success and I am personally willling to do almost anything for some relief. I may not be the 100 lb crohnie that is sometimes thought to be the poster child of those of us with this disease, but I want to be able to get back to work and live a productive life again. If it mean taking a slim chance with a blackbox warning to do this then I am all for it. All medications have some type of side effect and you are taking a risk every time you inject or injest it. The real question is whether the benefit outweighs the risk. In my opinion it does.
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