Hi all,

I joined and posted a while back about my daughter and how her doctor kept pushing for the vns but we were hesitant because of all the problems she has and the very good possibility of adding to them with the vns. To reiterate, she is 42 yrs., old mentally handicapped, who has had two neuro surgeries for a brain tumor, radiation therapy and in the last year had been having some behavior issues as well as some problems at the facitlity where she resides to the point where we had to call in the state to investigate. Another spot had also shown up on her brain that the doctors have been watching.

I am very pleased to be able to tell you all that we decided against the vns, much to the dismay of her neurologist who insists that there were very few side effects associated with it. We asked for the booklet that they give patients upon implantation of the device and were told that it basically just told you how to use the magnet. I was very upset to learn that they must not have ever read the booklet themselves since there were 2 and a half pages of possible side effects listed in it and it stated that it wasn't a complete list. At her last appt. with this neurologist, we explained that we had been encouraged to see another well known neurologist (at a different hospital), who was known to be very good with medications and finding the right combination. The goal was to get her off of the phenobarbital that she had been on for years and which they felt might be the cause of many of her problems. Her neurologist at the time wouldn't even consider any medication changes and said taking her off the phenobarbital wouldn't work and she would have more seizures. As of the first of the year, our daughter is off the phenobarbital and has been seizure free on a new drug called zonegran. She has been able to walk without a walker most of the time since her balance is so much improved, her disposistion has changed dramatically and her behavior has done a 180. We are still having some issues due to residual effects of the phenobarbital and some learned behavior during the past year but they are issues that can be worked through and solved over time and with some patience. The new neurologist is very pleased with her progress and we have thanked him for giving us our daughter back as we had forgotten what she was really like over the past few years with the changes that were so gradual, no one picked up on nor considered that a medication could be at fault. Needless to say, she now has a new neurologist. I am also happy to report that the spot the oncologist has been watching is also shrinking so her appts. are being spaced further apart for that. I don't wait for Thanksgiving anymore to give thanks as I have much to be thankful for everyday these days.

Just wanted to let all of you know which way we went with our decision since you were very helpful when I first posted here in the midst of much confusion and concern. Thank you so much for all you help and advice.

Hi galpal,

Well it looks like you definitely made the right call on that one. Asking for the patient's manual must have really startled the neurologist. Why doctors are not up front about all the possible side effects is a mystery to me. Every one should be fully informed before consenting to surgery.

I hope that your daughter continues to do well.

Hi Galpal,

Thank you so much for your post and I am so glad to hear that your daughter is doing so well with her med change. I too have been on phenobarbital for years (40+) and am currently weaning off with the help of an epileptologist. He is a new doctor for me as of last year and was shocked to hear that I had been kept on phenobarbital all of these years. Due to all those years, my reduction is very gradual and will take some time to be fully off of it. I am also on Lamitcal and Keppra, am still having absence seizures but no grand mal seizures for over 10 years.

One thing you might want to talk to your daughter's neurologist is having a bone scan done since phenobarbital can cause bone deficiency. No doctor all of these years brought that to my attention until last year when I started seeing the epileptologist. A bone scan showed slight osteoporosis (sp?) of the right hip, but other than that no significant problems. But considering I am 50 years old, some is normal for my age bracket.

Please keep us updated as to how your daughter is doing and I totally agree with your comment about daily giving thanks.. I know the feeling!

Hugs,
Cindy

Hi GalPal,

Your daughter is so fortunate to have you as her advocate. We all know that being a parent is a tough (rewarding) responsibility. When your child has any special needs or a chronic illness, that creates a lifelong job as an advocate for you.

Hope you are patting yourself on the back for all your research and your persistance in seeing that your child was properly cared for!!!!

:) Hurray for such a great outcome! Oreo

:Welcome: galpal

Thank you so much for sharing your daughter's story. It was a difficult decision you had to make. I want to commend you for your actions. You did what few people do, insist on ALL the information up front and not blindly accept whatever information some doctor choses for you to know. I'll bet you shocked him when you asked for the patient handbook. It is our goal and desire for EVERYONE who is considering the VNS to reach out and seek all the information about it and make a completely INFORMED decision getting past the marketing bullshit, the misinformation and lies and decieding for yourself if the risk is worth it.

No matter what the choice is, we support all our members. Surgery, no matter how minor cannot be reversed. They may be able to remove the componants, but once you cut into the body, it is forever changed. Surgery should be viewed as the very LAST option.

It's amazing what a change in medication will do. I do hope for the continuing success and improvement for your daughter and thank you so much for being part of our community.

:goodluck:

:D HI galpal!

So very nice to hear from you!

I can't add much more to what has already been said by the ones who've posted before me. I too commend you for asking for the manual prior to making such a life altering decision. Good on you for also getting a second opinion about the medications, and a new Neurologist that looked further into what the true cause of your daughter's issues.

THANKS so much for coming back to visit with us, and please keep us updated on how you all are doing. I wish you, your daughter, and your family many more HAPPY THANKSGIVINGS!! I will keep you all in my good thoughts and prayers for her continued improvement.

B)

Thank you all for your comments and support. As a parent, we do what we hope is best and pray it's the right thing. I will asked about the bone scan though I'm sure with all the falls she has had during her 41 years of having seizures, there would be some break down even without the medication. The one thing I do take great pride in, is that I did some research and found an article that described to the letter, all we had been going through with our daughter, including the doctors and facility where she lived, putting her on anti-depressants and mood stabilizers which only caused more problems. It seems that phenobarbital can cause a great many problems, both behavioral and psychological, in the mentally handicapped patient. If I can relocate this article, I will post it here and hope that others find it useful and informative as we did. I'm sure I have the main part of it saved somewhere on my computer. When I came acrossed it, I felt like I was reading an article about my daughter and it gave me hope that I really needed at that time. I made copies of this article and sent it to the administration at the facility where she lives, the nursing dept. and the house mother and staff of the cottage she resides in and asked them to please have patience during the medication changes. My daughter was also on phenobarbital for many years and it took a little over 3 months to wean her off of it totally. Her living in a facility was one of the reasons we didn't feel the VNS would benefit her as they aren't always aware of her seizures if they aren't the grand mal, plus the fact that in her limited mental capacity (that of a 5 year old) she isn't always able to put into words what she is feeling or might be experiencing in the way of side effects. With as many as were possible with the VNS, they could have gone un-noticed or untreated until a lot of damage was done. In fairness, I do have to say that the new neurologist also thought the VNS would be helpful in her case but was willing to try other things first and seemed to understand our concerns. Nothing is ever just black and white. My advice to anyone considering any type of treatment is "research, research, research". They don't call the internet the information highway without good reason and if you have access, there is no information you can't find, be it good or bad. The worse decision anyone can make these days is an uninformed one. This website was a great place to start and my thanks to it's creator for the service you provide to so many, including myself. : clap2 :

It's good to hear success stories, even if the VNS was not the chosen path. You mentioned your horror at seeing so many side effects of the VNS.

Here in the UK we receive information with the medication too, which always lists numerous side effects. Its enough to put me off from taking it, but I go ahead anyhow.

I had plenty of info on the VNS before having one implanted. And a number of years of deliberating too. Against my wife's wishes I went ahead. Why is it women are (nearly :D ) always right.

I'm glad you let us know about your daughter. You chose what you thought was best and she is doing great!

Do keep us posted on her progress!

Good Morning Andrew,

Funny how that happens with women, isn't it? :rolleyes:

I hear what your saying about medication and their side effects. I laugh when ever I see a coomercial for a drug and at the end it tells you what to watch for. It's like, why would you even want to take a chance? Sometimes the cure can cause more problems then what you already have. I have certainly been on some that made me feel worse then before I took it, but they are decisions and chances we have to take. Sorry your wife was right this time.

Increased seizure activity is one common side effect that Cyberonics fails to mention in any of their literature. According to a 1997 FDA press release this occurs in 20% of VNS patients. The MAUDE reports are filled with this complaint. If doctors are only telling their patients the most common side effects then they should also warn them that there is a 1 in 5 chance that this device will only make matters worse.


In the most recent study, most patients showed at least some
improvement with the vagus nerve stimulator. Half the patients
treated had at least a 20 percent reduction in the number of
seizures per day. In about 1 in 4, the frequency of seizures
decreased by more than 50 percent. In about 1 in 5, however, the
number of seizures actually increased.


http://www.fda.gov/bbs/topics/NEWS/NEW00576.html

There were a few things in that 1997 FDA press release that really caught my eye.

(1) FDA received an application to market the product on Jan. 27 and expedited its review because of its potential importance for reducing seizures in people who lack effective, alternative treatment.

Expedited its review ? I wonder EXACTLY what they mean by that.


(2) FDA's approval of the device was based on a review of clinical studies on safety and effectiveness submitted by the manufacturer

The VNS was approved because Cyberonics says it is safe.


(3) In about 1 in 5, however, the number of seizures actually increased.

Worsens the condition 20% of the time.


http://www.fda.gov/bbs/topics/NEWS/NEW00576.html

Excellent data, Dennis! Thank you for being so informed and keeping us in the loop.

As for expedited... I wonder if that means the same as when they expedited HIV/AIDS medications and allowed individuals to receive medication PRIOR to FDA approval on a "take at your own risk" basis. There was quite a bit of controversy regarding this decision, however it did allow for some medications to be trialed much sooner than if the pharma had to go the normal routine. In this instance, many people's lives were lengthened and improved since there was nothing at that time which was really working. I wonder how many other medications/devices have been expedited? Perhaps this is where Viox got the green light?

:D HI!

Dennis and Gel-Thanks for the informative posts...another day on the VNS Message Board that I learned something new.

B)

Increased seizure activity is a common side effect of the VNS and the FDA is well aware of this yet it is not listed as a potential adverse event in anything that i've read. Cyberonics lists everything under the sun as a possible side effect but they omit something that occurs in 1 out of 5 VNS patients. I don't know about you, but if my doctor told me that there was a 1 in 5 chance that the VNS would increase my seizures I would not have had the surgery. I've contacted the FDA and asked why Cyberonics does not list this as a common side effect. Only time will tell if I get a reply.

:D HI!

I'm curious why in their marketing literature there are very few side effects listed then a person has the surgery, gets the manual, and then gets to read about a heck of alot more things VNS can do to you.

I am also curious why does Cyberonics hammer away that some of the potential side effects go away in time when I have seen over and over on this board and others some side effects don't go away. Maybe they should say 'A person will adjust to shortness of breath, headache, nausea, vomiting, etc.'

Also, why does the FDA allow them to market VNS in a fashion that not everything is fully disclosed prior to implant? In medication commercials, they advertise some potential side effects, then advise to speak to your doctor about these and others. Heck, the latest commercial for Chantix talks about your medical history.

Why is it one way for Pharma and another for device manufacturers?

B)

Hey Dispatch, One way you might be able to satisfy your curiosity is by asking the FDA.

http://www.fda.gov/comments.html

I've found that they often avoid answering a direct question but they do reply.

:D HI Dennis!

Why :Thanx: Kind Sir...I'll give it a go and let you know about the reply!

B)

My question to the FDA.

Questions/Comments:
This question is in regards to Cyberonics and their Vagus Nerve
Stimulator.

According to a 1997 FDA press release the VNS actually increases the
number of seizures in 1 out of 5 patients. The problem that im having
with that is this common side effect is not listed in their Patient's
Manual. The manual lists 50 possible side effects and increased seizure
activity is not one of them. Why are they allowed to omit this common
side effect ?

In the most recent study, most patients showed at least some
improvement with the vagus nerve stimulator. Half the patients
treated had at least a 20 percent reduction in the number of
seizures per day. In about 1 in 4, the frequency of seizures
decreased by more than 50 percent. In about 1 in 5, however, the
number of seizures actually increased.

http://www.fda.gov/bbs/topics/NEWS/NEW00576.html

Their response


Thank you for your inquiry.

For any adverse events associated with the Cyberonics Vagus Nerve
Stimulator, please report them to the manufacturer and the FDA MedWatch
Program .http://www.fda.gov/cdrh/mdr/index.html

FDA CDRH Office of Surveillance and Biometrics monitors and analyze the
adverse events reports. If a problem is determined to be related to the
device, FDA may advise the manufacturer for the device to take certain
corrective actions on their device.

You may wish contact the manufacturer and bring this question to their
attention as well.


Kind regards,

Xiaoqiu Tang
Consumer Safety Officer
Division of Small Manufacturers, International and Consumer Assistance
Center for Devices and Radiological Health
U.S. Food and Drug Administration

:D

You asked a valid question and got a big run around answer. How long did it take you to get that response? <_<

If you call Cyberonics and ask a question, they will most likely say to call your doctor. <_<

B)

It took two days for that nonreply. I wrote Xiaoqiu Tang back and asked him/her to reread the message and answer the question.

:D

Good on you Dennis!

B)

I got a reply from Xiaoqiu Tang. This is what he had to say.

After checking the FDA adverse events database MAUDE http://www.accessdata.fda.gov/scripts/cdrh...AUDE/search.CFM, It is not clear to me if there are or there are not increased incident of seizure associated with Cyberronics Vagus Nerve Stimulator. If you have valid clinical data indicating such is the case, please immediately report all the incidents of seizure to the manufacturer and the FDA MedWatch Program. http://www.fda.gov/cdrh/mdr/index.html.

I wrote him back with this.

The 1997 FDA press release acknowledges the fact that 1 in 5 VNS patients have an increase in seizures. Your own MAUDE reports back that up. My question as to why Cyberonics does not list this as a side effect still has not been answered. Below are some examples for you. - Then I included 50 maude reports.

I wonder if I will ever hear from Xiaoqiu Tang again.

I'm surprised they answered regardless of how good the question was.

Sometimes I get lucky and they actually answer a question. Im still working on Xiaoqiu Tang for an answer.

Sounds like a song and dance routine. : beatit :

The FDA goes back and forth with you until you get so damn frustrated you give up on ever getting a simple question answered. This is the reply from Xiaoqiu Tang.

Pls send a copy of patient manual to me and indicate which model of VNS it is associated with and the year it was printed out. I will compare it with FDA's 1997 press release http://www.fda.gov/bbs/topics/NEWS/NEW00576.html.
FDA PMA database http://www.accessdata.fda.gov/scripts/cdrh...s/cfPMA/pma.cfm indicates that Cyberonics has submitted up to 100 supplemental modifications to the original VNS sice 1997, and its current performance and possible side effects may be very different from those of the 1997 version.

This is how I responded.

Would you please forward this exchange to your superior. I asked a very simple question and would like an answer. All that i'm getting from you is hogwash.

:D HI Dennis!

That was certainly some keyboard whippin' ya did! : whip : I am so glad you don't give up!

I thought the manuals were the same for every model or did I miss something?

Take care!
B)

Dennis,

Gotta love your spunk! I will be amazed if you get a response, but if you do I bet it still won't answer the question!

Keep pounding at them! : boxing :

And evidently I missed it too, Dispatch... thought they used the same manual for each model.

Hugs,
Cindy

Now i'm going back and forth with Xiaoqiu Tang's manager. Why are they so afraid to answer a simple question ? Could it be that they are just ignorant and cannot understand plain english ? Lets see..... I sent them 50 MAUDE reports as an example also included their 1997 Press release that aknowledges the fact that the VNS can cause increased seizures. I ask them why Cyberonics does not list increased seizures as a possible side effect and the good old boys at the FDA can't answer the question.

:D

They have "can't do" and "don't want to" attitudes when in all actuality, they can answer the question with a striaght up answer but don't want to...why...they don't want to be entangled in legalities.

B)

You've got spunk and a go get'em additude. Keep us the good work!

Hi Dennis,

As we all know, there was "funny business" going on with the FDA when VNS was approved for depression.

I'll bet warning bells and buzzers start going crazy every time someone contacts them about VNS!!!

I admire your hard work and persistance...you could be the one to open a crack in that fortress.

:Thanx: Thanks for your ongoing mission to get some honest answers! Oreo

I also contacted a women from the FDA that i've dealt with before and posed the same question to her. She just replied and informed me that she was forwarding my e-mail to the office of the ombudsman for a response.

Sounds like you are getting somewhere, Dennis. Keep on them!

Well after going a few rounds with Xiaoqiu Tang's boss and still not getting that simple question answered he informed me that he would forward the question to the Office of Device Evaluation. Below is a quote from his e-mail.

I can only give you my response from what I believe is supported in the regulations. That is; when information is well known to the medical community prescribing the device then there is some exemptions given to the manufacturer with regards to labeling, 21 CFR 801.109.

For those of you who missed my question it had to do with a 1997 FDA press release about the VNS which stated "In about 1 in 5, however, the number of seizures actually increased." I wanted to know why Cyberonics does not list increased seizure activity as a possible side effect.



http://www.fda.gov/bbs/topics/NEWS/NEW00576.html

<_<

So basically this person is saying since it is well known in the medical community prescribing the device that VNS can cause an increase in seizures, they don't require Cyberonics to label it??? That's obsurd. It may be well known in the medical community but the general public (patient and caregiver) has the right to know. It needs to be listed in the possible side effect list.

Well, let's see what the Office of Device Evaluation will say...

B)

Increased seizure activity is listed as the 2nd most common SERIOUS INJURY in the new Patient's Manual. You have to dig around a little to find it. Why it is not listed in the side effect section is anybody's guess.

Thanks for pointing that out to me Dispatch.

:D

It needs to be listed in their manuals as a potential side effect. Also, to the best of my knowledge, they just put this in the manual that came out in December 2008. They were aware that increased seizure activity began way before that per all the MAUDE reports.

B)

And lets not forget about the FDA press release from 1997. Cyberonics and the FDA both knew about this common side effect from the very beginning.

http://www.fda.gov/bbs/topics/NEWS/NEW00576.html