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August 6, 2009 at 3:06 pm #302508RoseParticipant
Saw this today thought it night be of interest.
News & Events
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FDA NOTE TO CORRESPONDENTS
For Immediate Release: Aug. 4, 2009
Media Inquiries: Office of Public Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA
FDA: Cancer Warnings Required for TNF Blockers
The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn?s disease, and other inflammatory diseases.
In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.
TNF blockers target and neutralize tumor necrosis factor-alpha (TNF-a), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. The drugs in this class include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).
Today?s action is based on the completion of an investigation first announced by the FDA in June 2008. An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average. About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.
Additional required updates to the prescribing information include incorporation of reports of psoriasis associated with the use of TNF blockers.
August 6, 2009 at 5:13 pm #332488TrudiParticipantThanks for the post.
Trudi
Lyme/RA; AP 4/2008 off and on to 3/2010; past use of quinolones may be the cause of my current problems, (including wheelchair use); all supplements (which can aggravate the condition) were discontinued on 10/14/2012. Am now treating for the homozygous MTHFR 1298 mutation. Off of all pain meds since Spring '14 (was on them for years--doctor is amazed--me too). Back on pain med 1/2017. Reinfected? Frozen shoulder?
August 6, 2009 at 7:27 pm #332489Jan LucindaParticipantI know a gal who got colon cancer after 5 years on Enbrel. Glad these warnings are out.
August 6, 2009 at 7:48 pm #332490Joe MParticipant[user=677]Jan Lucinda[/user] wrote:
I know a gal who got colon cancer after 5 years on Enbrel. Glad these warnings are out.
I know a guy who got liver cancer and never was on Enbrel. Go figure!
Anyway, for some balance:
http://interactmd.com/content/jury-still-out-tnf-blocker-link-cancer-arthritis-patients
August 6, 2009 at 7:58 pm #332491Jan LucindaParticipantEveryone makes their own decisions.
August 6, 2009 at 9:16 pm #332492SuzanneParticipant[user=20]Joe M[/user] wrote:
[user=677]
Anyway, for some balance:
http://interactmd.com/content/jury-still-out-tnf-blocker-link-cancer-arthritis-patients%5B/user%5D
But Joe, the FDA warning is for children and adolescents, not adults with RA. According to the FDA site:
“Understand that some immune-related diseases, such as Crohn?s, have been shown to increase cancer risk independent of treatment with TNF blockers while for others, such as juvenile idiopathic arthritis (JIA), it is unknown whether there is an increased cancer risk.”
Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.
August 6, 2009 at 9:18 pm #332493SuzanneParticipantAlso this from the press release:
“An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average.”
That they identified a time frame means something to me.
Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.
August 7, 2009 at 2:28 am #332494TiffParticipant[user=18]Suzanne[/user] wrote:
Also this from the press release:
“An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average.”
That they identified a time frame means something to me.
An average is not a time frame, it is an average of the times of all the cases they found. The range of those cases might be quite large.
Thanks, Rose and Joe, for the articles! I dread keeping up on this stuff so it is really helpful to have updated information around here!
I developed cancer of the thyroid after about 30 months of being on antibiotics for my skin. I had never had any type of steroid or TNF blockers. Did the long term use of antibiotics cause cancer in me? I doubt it, but I know lots of people who would think that it did. (We need to remember lots of people are very fearful of antibiotics and especially it being over used.)
The fact is that we don't even know what causes cancer, so deciding if a cancer is caused by the same thing that caused the RA (whatever that is?), the RA disease process, the meds, the environment, genetics, or other factors seems pretty difficult to me. We can only look for high correlations if it is directly related to the meds. I think it is safe to say that the correlation is not as terrifyingly high as it might be, and that is a good thing.
No one wants to be on those meds. They are all scared. Any hopeful news where RA is concerned should be celebrated. There isn't much of it.
I'm sorry if this sounds argumentative. I do not mean it to. 😛 It is just that there are people on this site who are on these meds (I might be headed in that direction myself) or have been in the past, and there are others who may be in the future. It is good to have both the good news and the bad to make decisions. AP won't work better if TNF blockers cause cancer.
August 7, 2009 at 3:04 am #332495sueraParticipantGood post Tiff.
Sue
RA
MTX, Enbrel, APAugust 7, 2009 at 3:30 am #332496SuzanneParticipant[user=45]Tiff[/user] wrote:
[user=18]Suzanne[/user] wrote:
Also this from the press release:
“An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average.”
That they identified a time frame means something to me.
An average is not a time frame, it is an average of the times of all the cases they found. The range of those cases might be quite large.
AP won't work better if TNF blockers cause cancer.
Another article put it this way:
“After more than a year of review, Food and Drug Administration scientists said the drugs appear to increase the risk of cancer after they are used beyond 2 1/2 years.”
They did not use the word 'average' here. I believe they have something that gives them a time frame now.
I totally agree with your last statement, but it is not uncommon for any type of FDA news pertaining to arthritis to be shared here.
Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.
August 7, 2009 at 3:33 am #332497SuzanneParticipant[user=45]Tiff[/user] wrote:
Thanks, Rose and Joe, for the articles! I dread keeping up on this stuff so it is really helpful to have updated information around here!
I hope you also took the time to read the updated FDA safety info for patients and providers. It is informative and current.
Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.
August 7, 2009 at 8:31 am #332498ParisaParticipantI believe alot of cancers are triggered by viruses, bacteria, etc. I'm sure there are other aspects such as toxic environment and genetic predisposition. When cancer research and autoimmune research start getting to the cause I believe they will make real progress in the treatment.
August 7, 2009 at 12:26 pm #332499SuzanneParticipantI have one more comment on this subject. Children are not miniature adults. If they were, we would not need pediatricians, just drs. who could divide by four.
No one questions that young children should not take mino or the tetracyclines.
Perhaps we are learning they should not take biologics or should not take them for an extended period of time. Time will tell.
Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.
August 7, 2009 at 12:34 pm #332500A FriendParticipant[user=13]Parisa[/user] wrote:
I believe alot of cancers are triggered by viruses, bacteria, etc. I'm sure there are other aspects such as toxic environment and genetic predisposition. When cancer research like autoimmune research starts getting to the cause I believe they will make real progress in the treatment.
Parisa,
Your post 'parroted' my thoughts… which have been further shaped by what I've studied/learned especially the past 2-1/2 years. One of the great scientists on his dying bed said something to the effect that “the germ is nothing; the terrain [of the body] is everything.”
My reading has enforced that if our body becomes more and more over-burdened with toxic wastes from many/all causes, is allowed to become overly acidic and not returned to a balance, it becomes the perfect 'breeding ground' for viruses, bacteria, parasites, mycoplasma, etc. to multiply and corrupt the very cells of our body, which can then switch from aerobic to anerobic, and cancer and other maladies can develop.
I believe we should never “blythely” take any medication protocols thinking they are a magic bullet, and not continually monitor other things. The magic bullet is the body given what it needs to stay or return to balance/health, and helped to get rid of what it doesn't need.
AF
August 7, 2009 at 4:35 pm #332501Joe MParticipant[user=45]Tiff[/user] wrote:
The fact is that we don't even know what causes cancer, so deciding if a cancer is caused by the same thing that caused the RA (whatever that is?), the RA disease process, the meds, the environment, genetics, or other factors seems pretty difficult to me. We can only look for high correlations if it is directly related to the meds. I think it is safe to say that the correlation is not as terrifyingly high as it might be, and that is a good thing.
No one wants to be on those meds. They are all scared. Any hopeful news where RA is concerned should be celebrated. There isn't much of it.
I'm sorry if this sounds argumentative. I do not mean it to. 😛
Not argumentative at all Tiff. In fact, a good dose of common sense. Thanks!
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