more news on Enbrel use in children | Arthritis Information
From the article:
"First, the agency wants to beef up labeling for Enbrel to include a
warning that, when used in children, the drug carries the risk of
death. Enbrel is up for pediatric approval for use in
psoriasis--currently it's only approved for psoriasis use in adults --
and in preparation for the advisory committee discussion tomorrow, FDA
staffers combed the adverse events database. They found some serious
problems in kids using Enbrel, such as malignancies, infections, and
neurological problems, many of them life-threatening--and some deadly.
Given the fact that the number of children on Enbrel is fairly small,
these serious adverse events are a red flag, FDA said. The agency is
recommending that the label be changed, regardless of whether the drug
gets the additional psoriasis nod."
http://www.fiercepharma.com/story/enbrel-antipsychotics-draw-warning-fire/2008-06-17
Suzanne2008-06-18 11:40:226t5 - did you notice they mention neuro problems now? The list keeps getting longer, doesn't it?
Suzanne, Yup it sure is. I get the feeling that in a few years some of these biologics will be GONE...neuro symptoms are a listed side of effect of enbrel...nothing new there. I can see them toughening up the labeling thoughMore from the FDA...
http://healthday.com/Article.asp?AID=616653
From that article:
The agency is investigating about 30 reports of cancer in this younger age group submitted between 1998, after the approval of the first TNF blocker, through April of this year. TNF blockers have also been linked to an increased risk of infection.
"I think it's a fair thing to say this is an area of ongoing concern that has not been resolved. It's not something new," Dr. Chaim Putterman, chief of the division of rheumatology at Montefiore Medical Center and Albert Einstein College of Medicine in New York City, said last month when the FDA review was announced. "[The drugs] were approved in adults, and more drugs are coming out, and everyone would prefer an indication in children, so the FDA has decided to clear it. It has always been a concern, and it's something that should be clarified."
Four TNF blockers are currently approved in the United States: Enbrel, Humira (adalimumab), Remicade (infliximab) and Cimzia (certolizumab).
The FDA review is focusing on the first three. All four are approved for multiple indications.
The drugs have clear benefits, experts said last month, and have revolutionized the treatment of some of these diseases.
[QUOTE=buckeye]neuro symptoms are a listed side of effect of enbrel...nothing new there. I can see them toughening up the labeling though[/QUOTE]
Neuro symptoms were not listed with the side effects in the recent FDA warning letter concerning Enbrel use in children. 6t5 had pointed that out the other day when we were discussing it.
[QUOTE=Lynn49]More from the FDA...
http://healthday.com/Article.asp?AID=616653
[/QUOTE]
From the same Healthday article, which covers this FDA news:
" A U.S. Food and Drug Administration advisory panel recommended
Wednesday that the psoriasis drug Enbrel be approved for use in
children who have moderate-to-severe forms of the skin disease.
The outside medical experts, in a 7-5 vote with one abstention, said
the drug appears effective, but they did express concerns about whether
it increases risks of malignancy and serious infections like
tuberculosis, according to Dow Jones."
7 for approval, 5 against, one abstaining. Close one, huh? "
Appears effective". Gotta love that endorsement, too. Thanks, outside medical experts!
but neuro symptoms are covered in the overal patient prescribing informatio nfor the medication. I'm not trying to imply that people shouldn't be concerned but only that it is not a new or unknown issue to the prescribers
[QUOTE=buckeye]but neuro symptoms are covered in the overal patient prescribing informatio nfor the medication. I'm not trying to imply that people shouldn't be concerned but only that it is not a new or unknown issue to the prescribers[/QUOTE]
Right, it has been in the patient info, along with risk of infection and cancer. We have been talking about the new, recent warnings regarding children. It has been covered as currently newsworthy, not old news. And this article is newly including neuro symptoms in the list of concerns for children. Which is a new development in a developing story. Stay tuned. You never know what will happen with a med that appears effective, according to 7 of 13 outside medical experts.
Amazing that you don't consider your anti pharma websites as propaganda.
Have you ever seen a child with severe psoriasis? I have, and it is a terrible terrible handicap in our society. Enbrel works like a miracle, and the appearance is obvious to anyone who sees a before and after. Your lack of understanding of the pain and crippling nature of these diseases makes it evil that you over and over promote scariness. This is not news, nothing is new except another anti pharm propaganda post by a person who does not have RA.No, Anna, she's a mother with a child who has severe RA. If APers are correct, and I truly believe they are, then Enbrel is a bandaid and nothing more. It takes the pain away. But the disease rages on behind the scene. Which makes sense if the posts we see here every day are indications.
Suzanne and 6t5 - is this also on the list?
Pip
[QUOTE=Pip!] No, Anna, she's a mother with a child who has severe RA. If APers are correct, and I truly believe they are, then Enbrel is a bandaid and nothing more. It takes the pain away. But the disease rages on behind the scene. Which makes sense if the posts we see here every day are indications.
[/QUOTE]
It obviously isn't a bandaid solution for some...
Patients with moderate-to-severe early rheumatoid arthritis (RA) achieved three measures of remission—radiographic, functional, and clinical—with ETN plus MTX, according to 1-year results from Combination of Methotrexate and Etanercept in Active Early Rheumatoid Arthritis (COMET) study presented at the annual European League Against Rheumatism meeting in Paris, France.1
"These results demonstrate that remission is a realistic therapeutic goal when combination therapy is initiated early in the RA disease process," concluded lead study author Paul Emery, MD, a professor of rheumatology at the University of Leeds in the United Kingdom.
Fully 80% of patients with early active RA achieved radiographic remission (or nonprogression defined as a change in total sharp score of ≤0.5 at 1 year) when treated with ETN plus MTX. By contrast, 59% of patients achieved radiographic remission when treated with MTX alone.
Reference
1. Emery P, Breedveld F, Hall S, et al. Clinical remission, radiographic non-progression and normalized function with the combination of etanercept and methotrexate in the treatment of early active rheumatoid arthritis: 1-year results of the COMET trial. Presented at: EULAR 2008; June 11-14, 2008; Paris, France. Abstract OP-0008.
Lynn492008-06-18 23:47:55[QUOTE=Pip!]No, Anna, she's a mother with a child who has severe RA. If APers are correct, and I truly believe they are, then Enbrel is a bandaid and nothing more. It takes the pain away. But the disease rages on behind the scene. Which makes sense if the posts we see here every day are indications.
Suzanne and 6t5 - is this also on the list?
Pip
[/QUOTE]
Pip, are you saying that AP is more than just a band aid? That clinical remission is different for AP users than biologic users? Clinical remission is much more than just the pain going away. Since there is NO cure, then all any of us can hope for is clinical remission. From what I've read clinical remission is the same for APers and is defined the same way as clinical remission in biologic users. Of course I may be wrong but clinical remission is just that no matter what your choice of drugs to achieve it. Lindy
Check out Amgen's statement. They've awarded themselves the abstaining vote. Isn't that special?
http://www.fiercebiotech.com/press-releases/amgen-and-wyeth-statement-outcome-dermatologic-and-ophthalmic-drugs-advisory-committe
Pip, that link looks like adult info, so no, I don't think it is on the new children's warnings. A friend who is a physician told us from the beginning that peds is not just adult medicine divided by four, and I believe that.
I know three adults with psoriasis, though, and none of them are on Enbrel for a variety of reasons.
This article says the new pediatric indication for psoriasis would only mean about 1,000 new patients a year:
http://www.reuters.com/article/marketsNews/idINN1847493020080618?rpc=44
BirdGirl makes a very good argument as does Lynn49 with her facts. It's easy to constantly criticize and look for negatives for a medicine when you don't have the disease. If you have ever seen someone with severe psoriasis you would understand why using a drug with rare side effects is a acceptable option. I for some reason don't like to even sit next to someone with severe psoriasis. If my child had it I would absolutely use the enbrel and be very diligent to watch for the signs of bad side effects just as we with ra should be doing even those that take zithromax.
Zithromax (Azithromycin) is a popular antibiotic manufactured by Pfizer that is used to treat different types of bacterial infections such as bronchitis, pneumonia, tonsillitis, skin infections, ear infections and sexually transmitted diseases. Recently there have been reports of severe side effects from the drug, including liver damage resulting in the need for liver transplant surgery and liver damage resulting in death.
Zithromax, also referred to as the "z-packs" and "tri-packs", is in a class of drugs known as macrolide antibiotics. Like all macrolide antibiotics, Zithromax prevents the spread of bacteria by interfering with their ability to make proteins. Until recently, Zithromax was widely prescribed for all types of bacterial infections, from pneumonia and sinus infections, to throat infections and sexually transmitted diseases. However, recent warnings have been added to the drug's label regarding abnormal liver function, jaundice, necrosis, liver failure and even death.
Symptoms of liver damage from Zithromax include:
- Abdominal pain
- Fatigue
- Nausea and vomiting
- Clay-colored stools
- Dark urine
- Skin discoloration
Zithromax was approved by the Food and Drug Administration in June of 1996. There are reports that Pfizer knew about potential side effects as early as 1998 but waited to change the warning label until they were required by the U.S. Food & Drug Administration to do so in late 2000. The new warning label was modified to state that liver failure, abnormal liver function, necrosis and jaundice had been reported by some patients taking Zithromax.
There is no drug that disrupts the life structure that does not have some very serious side effects. To those that constantly look for every possible negative or rumor to the medicines that we must take I ask you, what do you think we should do, be cripples?
LEV
My apologies to the board, I don't usually get so upset but Anna's continual attacks against Suzanne just reached the boiling point last night.
Lindy - yes, I'm saying AP is more than a bandaid. The theories behind the two treatments are radically different.
One theory says your body is attacking itself and the method of treatment is to reduce your bodies ability to fight back by stopping some naturally occuring compund in the body - ie - block the TNF's or remove the B-cells. The other says you have an intracellular infection caused by a mycoplasma or some other nanobacteria that's hiding in your white blood cells that your body is attempting to fight but missing because they've co-opted the very cells in your body designed to remove a pathogen.
So, in various studies, when researchers use different scales for remission (ie counting going from ARC 20 to 50 as remission) or in some cases with Mino studies (counting non-complaince as failures) yes, I question the methodology. And while we're on the subject, if TNF's are all that, why is always better with MTX?
And I question your use of the word 'cure'. If 10% of APer's manage to go med free and stay there, is that not a 'cure'? It's a cure when cancer survivors make it 5 years cancer free.
From posts here on AI, it seems to me that most people go 3 years tops on the first biologic, about a year on the second, and about 3 months on the third. Then the freakin' rheumies say - ooooh, to bad, looks like you have severe refractory RA, here, sign up for a study and be our guinea pig. Does that not sound like Cordy to you?
It's not whether or not remission was reached, its if it's maintained. And for how long? Same with the APers. All my research is into this question. How to maintain remission and what makes the medicine free remission APers 'special'. Is it co-infections? Gut mucosa? What is it?
Now, my question. If the APer's are right, and it is infecton, then doesn't that explain the infections re-emerging on a immunosuppressent?
And if APer's are right, and you choose to suppress your immune system, and there is an underlying infection (be it myco or not), doesn't common sense say you're going to get sicker? Where the hell is common sense in all this? It seems to me it's a much larger leap of faith to say your body is 'attacking itself' than it is to say 'I have an infection' especially considering all the reports of fevers, chills, aches, and feeling 'flu-like' before a flare.
How is that not a bandaid?
Pip
Again, that's your theory. My sister-in-law has used MTX for over 15 years. She hasn't gotten sicker and lives an active life. She just recently switched RD's(her's retired) and he says she is in remission. Not to bad for a 72 year old women!
[QUOTE=levlarry]
To those that constantly look for every possible negative or rumor to the medicines that we must take I ask you, what do you think we should do, be cripples?
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