Dangers of enbrel--this is a SCARY drug!

** Originally posted by ScottinFL **

I just searched enbrel on Yahoo and Google. This is a very scary drug!!

It seems that the FDA ordered the company to go back and revise their warning label after several deaths and many serious infections, siezures and more.

Wow, horrible.

Scott

Other Dangerous Treatments Enbrel

Many other patients with autoimmune diseases such as rheumatoid arthritis have used Enbrel (etanercept). This drug was approved by the U.S. Food and Drug Administration in 1998. Like Remicade, Enbrel was widely promoted its maker as a wonder drug, however it also has potent and dangerous side effects. The adverse effects that are known are often serious and can be fatal. Attorneys believe that many patients have not been fully warned of the risks of using enbrel and many have suffered serious long term injury.

Enbrel is a genetically engineered antibody, that works by inhibiting the natural actions of the body's inflammatory and immune systems. Enbrel works by inhibiting part of the body's natural defenses against serious infection called the tumor necrosis factor (TNF). The suppression of this chemical can lead to serious problems however.

Although many sufferers of rheumatoid arthritis prescribed Enbrel have had positive responses, the drug has a dark side. In subsequent studies Enbrel is reportedly linked to serious infections and sepsis, nervous system disorders such as multiple sclerosis, seizures, blood disorders, tuberculosis, SLA, inflammation of the nerves of the eyes, and death. Other researchers are concerned about the long-term effects of Enbrel and TNF antagonists in general both in the dangers of infection, and autoimmune disease.

Within months of approval, reports about Enbrel noted nearly thirty serious infections and six fatalities. This prompted a warning letter to be send out to prescribing doctors and added to the drug label warnings section. The new warnings discussed infections and sepsis and advised doctors not to use Enbrel to use caution in patients with a history of recurring infections, and to stop Enbrel if serious infection arises.

In October 2000, a second warning letter was sent out to doctors stating that "Rare cases of central nervous system disorders, including demyelinating disorders such as multiple sclerosis, myelitis, and optic neuritis; have been reported in patients with rheumatoid arthritis who have received Enbrel therapy [and that] rare cases of pancytopenia, including aplastic anemia, some with a fatal outcome, have been reported in patients with rheumatoid arthritis who have received Enbrel therapy."

In January 2002, the FDA warned about serious nervous system problems related to Enbrel, involving demyelination, producing MS and other conditions; patients were also warned to watch for vision changes.

Remicade has also been linked to the deaths of congestive heart failure patients. On October 18, 2001, Centocor, Inc. issued an "Important Drug Warning" which announced that seven of one hundred one patients treated with Remicade had died during ongoing testing, compared to zero deaths among 49 test patients not using Remicade. The following day, the Food and Drug Administration revealed Remicade's potentially negative effects on patients with congestive heart failure. Subsequently, a detailed statement was issued to physicians describing the reasons for the warning and recommended treatment changes for patients with congestive heart failure taking the drug. According to the Centocor, Inc. it was determined that patients with moderate to severe congestive heart failure were at higher risk of death or worsening of their condition while taking Remicade. For congestive heart failure patients with Crohn's disease or rheumatoid arthritis, Centocor, Inc. advised against initiating any Remicade therapy.

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31 replies. Join the discussion

** Originally posted by Emsmom **

You've done all this research and you've found something that has worked well for you. I truly am happy for you and hope that you have continued success.

My question is what you would do if you were in my position. I don't know if you've read everything I've written. To recap~~ my 14 year old daughter has been on methotrexate for nearly 12 years. She was on Enbrel for two years and has been on Remicade for 20 months. She takes prednisone periodically, though we have fortunately not needed it long term since starting biologics. She also takes a non-steroidal twice a day and tylenol as needed for pain. She has been in and out of physical therapy. Her diet is really quite healthy but by no means perfect. But it's quite good for a 14 year old. Several years ago we tried stopping all drugs after the arthritis had been well controlled for a while. Within 3 weeks all hell broke loose. My daughter couldn't walk, dress herself, hold a pencil, etc. So I was faced with a tough decision~~~ back on meds or allow my daughter to become severely and permanently disabled. Arthritis can be very aggressive and in many cases you simply don't have 3 or 4 months to spare without permanent damage occurring.

I agree~~ the drugs are scary. And my daughter is in the first generation of kids to start them before puberty. The decision to use them was not an easy decision to make. But when faced with deciding between possible side effects and the known effects of an untreated disease, I really feel that I had no choice. My daughter is very bright and involved in her health care. We~~ my husband, her medical team and I~~ share all of the info with Emily. She chooses the risks of the meds that allow her to participate fully in life over being permanently disabled and unable to take care of even her most basic needs.

So, my question is this~~` With all the research you have done, have you found anything that is non pharmaceutical that would quickly, before damage could occur, allow my daughter to have quality of life and a pretty normal childhood? And that would prevent further damage from occurring? Remember, we're dealing arthritis as well as psoriasis. If so I really would love to hear about it.

Thanks!

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** Originally posted by nitegale **

Emsmom~

I am so sorry about what is happening to your daughter. It must be really difficult to have an ill child. The decision to take these meds with all their potential risks is not an easy one, and I'm sure you thought long and hard before you made it. No one wants to take meds if they don't have to, but sometimes there is no other choice.

I hope for you and others a cure can be found.

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** Originally posted by GitOverIt **

Emsmom: yes I sympathize with you...and following the Dr's advice is why we go to them....BUT....while I was doing what they suggested, I would still be doing my own searching ..."I just watched Lorenzo's Oil a few months ago and knew if that were me, I would be doing the same as his parents....that's just me, when others accept the inevitable is when I start fighting!!!

I don't know if you followed the thread on "saw the derm yesterday interesting visit" by girl24..... but she asked Dr. Heng about PA and this is her answer!
Keep in mind this is a researcher in psoriasis and PA..head of the derm dept at UCLA and on the cutting edge of what is happening in the field of P and PA

I would call and make an appointment with this doctor....even if it is only a phone appt. I'm not trying to be pushy but you did ask :p

Yes, psoriatic arthritis is associated with streptotoccal infection in patients with HLA-B16 and HLA-B27 genetic background.

Antibiotics - e.g. keflex for at least 4 weeks or longer is the answer.


I will divide my advice into two parts:

Joint disease: The following induce the formation of immune complexes which lodge in the joints. If you have the right genetic background e.g. HLA -B27, you will get joint involvement with the following: penicillin allergy, streptotococcal infection, herpes simplex infection, lupus tendency/cryoglobulinemia, and hepatitis.

I will deal with these in turn::
(a) penicillin allergy: penicillin is used to prevent infection in the udders of the cows. It is fed to the cows in the hay feed, and is excreted in the milk. The milk from different herds is pooled and there is some penicillin in every batch - and the concentration of penicillin varies depending on when the cows are fed the penicillin (about once every two weeks). Do not ingest anything that is made from milk (milk itself, yoghurt, milk shakes, ice-cream, puddings, desserts, cream soups with milk, bread with milk, sauces with milk, cheese etc).

(b) Streptotoccal infection - you also need to have HLA-B16 genes. Sources of Strept infection (throat, ears, sinuses, axillae, groin, perianal). Keep your ears dry, gargle with soy milk (contains soy agglutinin which binds to your raw mucous membranes of your sore throat (induced viral infections, respiratory allergies, dry air from weather, airplanes, heaters in house), and prevents the streptotoccus from binding to the raw surfaces and inducing immunoglobulin synthesis by B lymphocytes, and cytokine production causing redness and swelling. If you are too late, the soy may not work and you will have to go on a course of keflex 500 mg 4 times daily for 4 weeks. Usually patients with penicillin allergy are not allergic to keflex. To be sure, you take one capsule, and if you do not have a rash after 24 hours, you may take the full dose of keflex. Keep your axilla/groin dry to avoid yeast (Candida albicans) infection, which will predispose the skin to other infection (streptotoccus and staphylococcus). Use regular talcum powder (no corn starch as this will feed the yeast, and no sodium bicarbonate (bicarbonate or soda) as this lowers the resistance to yeast infection. If you have diabetes, the diabetes must be treated.

(c) herpes simplex. this should be treated episodically. If you start to have the symptoms of a prodrome (u.e,. irritation etc, which tell you the flare is imminent) you should start on a antiviral (famciclovir, valtrex, acyclovir) for 5-7 days.

(d) lupus tendency tends to aggravate the condition because this is associated with a defect in the removal of circulating immune complexes, which therefore tend to persist for a longer tune.

(e) hepatitis. This is a difficilt issue to treat, but new drugs are being developed.

Psoriasis Plaques/Lesions:

Psoriasis is a genetic problem induced by injury. Once the injury (allergic reactions, infections, cuts, wounds, sunburn etc) is present, a chain of reactions which is supposed to assist in wound healing is induced. In psoriasis, the epidermis grows too quickly, and instead of turning over once every 60 days producing mature, functional stratum corneum/barrier cells, the psoriatic epidermis turns over once every 4 days, producing defective stratum corneum/barrier cells which are leaky and allows bacteria to enter the skin. Curcumin, which is derived from turmeric, helps the skin turnover to slow down to once every 4 days. This is accomplished by inhibiting phosphorylase kinase, too much of which is found in psoriatic skin because of a genetic defect (17th chromosome) which does not allows phosphorylase kinase to switch off after wound healing (see review article in the Dermatology Times).

To grow your barrier back, you must address and avoid all the precipitating factors. Your doctor or I can help you identify these for treatment. I will also send you the formed letter which contain some information on this. Please also check the information website: psoriainfo.org, and click on all the squares to open up the information pages.

Please let me know if I may be of further service. Please also check our website: psoriainfo.org and click on all the squares to open the information pages. It is only with knowledge that you can be without disease despite your genes.

With kind regards,

Madalene Heng MD, FRACP, FACD
Professor of Medicine/Dermatology
UCLA School of Medicine

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** Originally posted by bratsareus **

That is some interesting findings Sally. It sure couldnt hurt to try that. Its a lot easier to try before going to the big drugs.

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** Originally posted by Emsmom **

Thanks for the feedback. You've given me some interesting research to do.
My daughter has had more that one strep culture (not rapid) and they have all been negative. She is also HLA-B27 negative. I'll have to ask her rheumatologist about the HLA-B16.

I am a believer in modern medicine and am very thankful for the drugs that are available. But if there are drug free ways to help as well I am always open to those.

Liz

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** Originally posted by Emsmom **

Thank you for your kind words. Yes, it sometimes is overwhelming when a child is chronically ill. But we are fortunate that Emily has had access to the best medical care available and has been able to lead a good life, even though there have been some very rough times. We were recently at a Juvenile Arthritis conference and a lot of families in attendance have not had that access to care. It really shows when you look at the disability that many of those children have. It makes me more thankful than ever for what we have, including those meds!

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** Originally posted by jennmkirby **

Liz,

Just wanted to say that I have a 2-year-old, and I imagine the decision to put your daughter on the drugs at that age must have been just agonizing for you! But I'm glad that there is something available to help her. I'm sure you would love to find something outside the realm of pharmaceuticals for her to take or do. (The diet changes and supplements, etc. have helped me a lot, but I fully recognize that I'm lucky that way.)

Not sure what else to say... just wanted to extend a warm pat on the shoulder and support from one mom to another. :)

jenn

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** Originally posted by Emsmom **

I appreciate the support.

Liz

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** Originally posted by NL **

We can all read the package inserts. This is a very difficult decision and I am sick and tired of constantly reading the warning label on this site.

Good luck to you Emsmom.

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** Originally posted by chaimFL **

We can all read the package inserts. This is a very difficult decision and I am sick and tired of constantly reading the warning label on this site.

Good luck to you Emsmom.

Enbrel is really only scary to people who do incomplete research or just don't know any better. Most doctors now-a-days hold it in very high regard with a strong safety profile.

The digusting part is that people would post warnings about something they know nothing about just to be disruptive.

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** Originally posted by NL **

Thanks chaim.....guess I should be using the ignore feature too but I just keep wanting to defend myself and my choices. It's not worth being crabby and upset on a Monday morning though.

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** Originally posted by evergreen **

Hey Emsmom! I've had P for over 10 years...I've tried just about everything you can get without a prescription - including ingesting all kinds of nasty tasting stuff...the only thing that helped me that wasn't modern medicine was a nasty sunburn I got - wiped out most of the P on my body. Dovonex, triamcinilone, MTX & Humira have all helped; the last two, I believe, are getting to the core of the problem, not just the symptoms. I've got PA too, so I support anyone using anything to combat this yucky disease. The dull aching in my spine is gone, the quick onset of swelling, pain and disfiguration in my thumbs is receding and my nails look almost normal now. I think the key statement is, '...many sufferers of rheumatoid arthritis prescribed Enbrel have had positive responses'. It's those positive responses that make the risk worth it...my 2 cents.

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** Originally posted by chaimFL **

Hey Emsmom! I've had P for over 10 years...I've tried just about everything you can get without a prescription - including ingesting all kinds of nasty tasting stuff...the only thing that helped me that wasn't modern medicine was a nasty sunburn I got - wiped out most of the P on my body. Dovonex, triamcinilone, MTX & Humira have all helped; the last two, I believe, are getting to the core of the problem, not just the symptoms. I've got PA too, so I support anyone using anything to combat this yucky disease. The dull aching in my spine is gone, the quick onset of swelling, pain and disfiguration in my thumbs is receding and my nails look almost normal now. I think the key statement is, '...many sufferers of rheumatoid arthritis prescribed Enbrel have had positive responses'. It's those positive responses that make the risk worth it...my 2 cents.

I had a similar reaction to a sunburn, which is what drove me to get a home UVB unit. I was doing yard work one Sunday and got a sunburn on my back and shoulders...when the sunburn cleared so did my psoriasis.

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** Originally posted by jaken **

I personally will never use a drug unless it has FDA somewhere on it. Companies will come out with some "miracle cream" and they only expect to sell it for six months before everyone realizes it will never work. And that's why those creams cost you $100-$200 a tube. All they want is your money. And the sad thing is, those companies are targeting those without insurance. Throw a few ads on the internet, tv, and radio.....boom they got business. And the biggest thing is....these companies never submit their product for FDA testing. And one of the biggest things that the FDA tests is if the drug has EFFICACY.

the only non-prescription therapy that i've found to work is SUN! however, i just got a fungal infection from using the tanning beds at this place, and now i am waiting for that to clear before i can begin using enbrel.

I will use enbrel. i have even notified my primary doctor that i am going to be using it so that if any side effects pop up.....i can be treated promptly. personally i think that the doses that they give are too high. maybe a lower dose could mean less serious side effects.

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** Originally posted by Emsmom **

I, too, am very cautious about supplements and such. I run everything by my daughter's pediatric rheumatologist and together we all decide whether or not something is a good option for my daughter. As a team, I think it is important that we make all of the decisions together.

Liz

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** Originally posted by Allie **

Jaken,

Be careful going to low of a dose on Enbrel. Steve (makeitgoaway) was on a 25mg/week dose & flared. Due to this he found out you cannot go below 50mg/week or your body produces anti-bodies to kill off the drug.

Steve, Please correct me if I am remembering any of this incorrectly.

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** Originally posted by chaimFL **

Enbrel is one drug where the side effects are not really dose dependent. I know that in clinical trials there was no increase in side effects in patients taking 100mgs/week vs. patients taking 50mgs/week. I would assume this would be true if you compared the pediatric dose of 25mgs/week to the 50mgs/week adult dose.

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** Originally posted by luvwinnie **

Curious: Can you post a link so we can view the source? Thanks.

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** Originally posted by chaimFL **

Well, it was ages ago that I saw the study results. I'm trying to locate them now, but I have no idea where my original source is. I did, however, find this:

[T]he percentages of patients reporting adverse events in the 50 mg twice a week dose group were similar to those observed in the 25 mg twice a week dose group or placebo group.

I don't however find the above statement to be adequate in comparison to what I have seen in the past. The source for the above is: http://www.fda.gov/medwatch/SAFETY/2004/may_PI/Enbrel_PI.pdf

I'll tell you that in my quick searching that they did see an increase risk from 100mgs to 50mgs in RA patients. I'm not sure why just in RA patients since it was not seen in P patients, but I'll have to continue my search later when I have more time.

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** Originally posted by luvwinnie **

Chaim, my request was for the original poster!

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