FDA INVESTIGATED CONCERTA

[thogan]

I read a article on the CNN website discussing the FDA's concern over Concerta in regards to children. Look under the health topics on the CNN page to read more. The last two days the FDA held a sub-committee meeting discussing possible problems relating to problems discovered in some children. Here is the exert which caught my attention:

"But a routine Food and Drug Administration review of Concerta's use in children turned up more reports of psychiatric reactions than anticipated, including some that aren't explicitly labeled, such as suicidal thoughts, hallucinations and violent behavior. A subsequent review of all methylphenidate products found similar reports."

The information is publised on the FDA's webpage under Pediatric Advisory Committee in the FDA news area.

My son has been on Concerta now since February and we have lately been concerned with some behavioral displays that started to bug us (was suddenly afraid of certain bugs which he used to catch and never had problems with, fear of our swimming pool). Things just didn't make sense so we took him off of Concerta and the last couple days he has been great (other then more hyper and impulsive which has returned again).

Anyways just wanted to share this concern with all of you.

Regards,
Tom in CT

[kstquilter]

i guess i'd take all this with a grain of salt. i think these meds are highly over prescribed. not that alot of our kids don't need them and my dd does take ritalin. but i think too many people think it's a quick fix for poor behavior or parenting.
i remember being on phen-phen a few years ago. it worked great for me and i was devestated when it was pulled. i talked to my dr. about all the fears of death flying around.
she said it was being way over prescribed. people who shouldn't have been on it like smokers or people who wanted to lose 10 pounds, people taking significantly more than they should have been, etc. she said she would like to see the history of the actual people who died or were very sick. she said she'd bet it was a case of abuse in some form of the medication and she guessed it would eventually come back in some form down the road.
i can't tell you how many packets of stuff i've gotten from lawyers trying to get me to sue because i was on phen-phen. i wouldn't even open the packets before shredding them. i knew i was the right candidate to be on it and i was seeing my dr. on a regular basis while she monitored my progress.
maybe i've just been fortunate because dd has responded well to ritalin. it's in and out of her system in a short time and everyone has noticed a difference in her behavior when she's on it with none of the awful side effects listed.
i hope if there is truly some real problem that they can fix it but hope it doesn't turn into mass hysteria either.
i hope i didn't offend anyone because i didn't mean to. i trust CNN as a whole but also know the media can blow things way out of proportion at times. and this is exactly the kind of thing to feed on the guilt we can already have for putting our kids on meds.
karen

[mothercat]

One thing I learned a few weeks ago with help from others on line here...Jared has some fears that have developed lately...ONLY he isn't medicated. We do subconsciously look for things sometimes to blame either the adhd or the meds for...when it is just a kid thing. I was very concerned about Jared a few weeks ago, but since then I have watched and learned that most of his are just natural things kids go thru.
Alot of kids are medicated for every little symptom but jared is only medicated with concerta and that is for school focus. Maybe some problems are more a combination of drug issue ??
Medicating our kids has always been a controversial issue and can get rather heated but it is my opinion that if a child needs to have it in order to be able to learn then it is the parents choice. I am sure that some people do see it as the easy way out (believe me.. I miss the meds very much only because I am dealing with a three generation/ two household situation tho. But Doc said no for the summer an I have to just deal with it.))
..I know a couple that has their son so drugged he is like a zombie...they both work different shifts and dont want to deal with it.
I dont agree with people like this....medicating is a ver important and serious thing that should be thought out and taken seriously... off the box now.. anyway I agreee with Karen ...we live in a society where the word "lawsuit "is right up there with the " Do you want fries with that?" AND I dont really find the media that
good of a source unless you are looking for entertainment news.

[finnmom]

Thank´s for sharing this with us, as others have already said...mayby best with a grain of salt....

Any med´s can cause you trouble if used too long, too high dosage, wrong med´s for wrong thing......
Obviously all these thing´s get our attention because at least I, do think about the reason´s behind medicating my ds....it´s natural to be a bit on your toes on this, and I think it´s the best thing we can do as a parent.

My son is on concerta 36 mg, only on schoolday´s, I have to say I dont see any difference on his mood´s while on med´s vs. without med´s, luckily.... If you have serious doubt´s about your child´s moodswing´s, please contact your doc and discuss these differences with him immediately!!!

[thogan]

I have contacted the point of contact at the FDA directly who is involved in this sub-committee investigation: Jan N. Johannessen, Ph.D. who is the Senior Science Policy Analyst, Office of Science and Health Coordination FDA, Office of the Commissioner, HF-33. She said she will have the slides of the sub-committee meeting and minutes back in about two weeks and will forward them to me so I can read what the committee discussed and determined. The FDA plans on taking the next year or so to really investigate specifically Concerta along with other methylphenidates and revise their warning labels.

When I first saw the article on CNN's website I did take it with a grain of salt but certain things in the article caught my attention only due to recent unexplained problems in my son's behavior. I then went directly to the Food and Drug Administrations website (www.fda.gov) and read more about what the Pediatrics Ethnics Committee were actually reviewing. From what I've read the concerned symptoms do not appear to be a common complaint. However, when you note something that may (or may not) explain the reason for unexplained behavioral issues relating to your specific child I like to go directly to the source.

Concerta (18mg, now 27mg) for the most half saved my son's academic performance in school (first grade). So much in fact that he no longer qualified for special programs. My wife and I fought to keep my son in OT/PT for next year since not only does he have ADHD but he also has Sensory Integration Dysfunction. My son's been off of it for about four days now (only due to he unexplained fears, the FDA article was found yesterday). The first two days of not being on meds he was pretty calm, controlled his impulsiveness. Day three (yesterday) he was off the wire. Running around, very hyper, very compulsive. His sense of humor which was missing while on meds did come back and he was outside with his butterfly net chasing bugs and bee's again. Another weird thing we noted was while he was on meds he would not use our silverware which had a plastic handle. He said that the handle bugged his hands. As soon as we put the silverware in front of him he would remind us he didn't like it. For the past two days he has eaten with this silverware and hasn't complaint or made any comments. Things that make you go hhumm.

He also has two blood clotting disorders (thrombophilia). The blood clotting aspects are my specialty since I am an officer for a major national patient-advocacy group working with the CDC in regards to blood clots and blood clot disorders. The ADHD aspect is new to my wife and I and it's been a real frustrating process trying to learn as much about this as I can to better his life. The part I don't like is depending on which pediatrician/Psychiatrist you speak to they say that my son could have Asperger, PDD, etc. I know they can test for Fragile X Disorders (since it's a genetic test) but I hate how the other diagnosis are based upon a subjective observation and checklist of symptoms.


Frustrated in CT
Tom

[kurs10b]

<quote? Another weird thing we noted was while he was on meds he would not use our silverware which had a plastic handle. He said that the handle bugged his hands.</quote>

My son has a similar problem, but it has to do with pencils squeeking. If the pencil is not completely sharp, he thinks it makes a weird noise. This only bothers him when he isnt on concerta though.

I cant take him off the meds for summer or he would end up getting kicked out of summer camp. As long as he is on his medication he seems to be fine. He is still hyper and loves to laugh and play, but he has enough control to walk away if someone is bugging him. I took him off for 1 day and it was horrible.

[mothercat]

My son cant use pencils in school for that reason but it
isnt the concerta or anything like a med reaction...he has been that way since 3yrs old...and it is a workable thing..they let him use erasable pens. Alot of adhd kids have some sensory probs but we tend to try and let common sense prevail around here.

[Linda]

I think it is all a "crock". Paul was on concerta for a long time and the only thing it did for him was FOCUS....no side effects but the meds did what they were supposed to do.

If I listened to everything that came out as a warning I would go nuts because it gets detracted in a few years anyway

[catseye]

Personally I would not tend to put a whole lot into what the FDA says anymore... BUT EVERY CHILD IS DIFFERENT!! I can NOT stress that enough... My sd did ok on concerta, but she did get obsessive so she was switched to adderall xr...

If you are seeing this in your child, you know your child the best!! Talk to the dr, express your concerns, and see what the dr comes up with!! Good luck!

cat

[sportsmom]

BUT EVERY CHILD IS DIFFERENT!! I can NOT stress that enough...

Cat is so right~~~what works for one might not work for another. Everybody has a different chemistry and of course all stims are not going to be the same for everyone. Just like some people can take an acetaminophen but not an ibuprofen.

[kstquilter]

i agree with the others, every kid is different and what works for one, doesn't work for another.
dd never has had any real side effects and she's been on ritalin most of her life. adderall xr didn't do much for her at all. concerta didn't work as well as ritalin did either.
but it does help make a more successful student, employee and person.
your child also has different problems in addition to adhd. i would think that would make any or all medications work different than it might if your child only had adhd.
i try to use my own common sense, instincts and watch my child. no one knows them better than you do.
karen

[MomA]

This post scared me for a bit because I've been waiting for Concerta to be among those medications with new concerns. But my son's so much more in command of himself than when on Adderall (and WAY more than with nothing), that I don't see those side effects doing anything to him.

[finnmom]

kstquilter said:

i try to use my own common sense, instincts and watch my child. no one knows them better than you do.

I agree, after all, we as their parent´s, do deside and it´s our responsibility to monitor them closely... I thik that´s the best way; keep close eye on them, see how it goes and do as feel´s best...

[Budsmommy]

It is so nice to read that people are dealing with the same issues I do. My son is not on this medicine he is on adderall 10mg. I had a very hard time deciding whether to put him on it or not. For me I decided to try because my son complained of being nervous and anxious all the time but didn't know why. He said he was sad as well. In first grade I was told he was just immature. It was communicating with his 2nd grade teacher that I found his real problem was sitting still, implusive behavoir, blurting out things. He would not concentrate on his work. Many times he would begin before listening to directions. I put him on the medicine and the teacher saw a world of difference. He is not on it this summer and is fine because he only seems to need it to concentrate (don't get me wrong he doesn't listen as well when he is not on it however this is a problem I can deal with and try to correct without the medicine) What has made it easier to keep him on the medicine is that he seems happier and more adjusted. I hate hearing these studies because my husband gets all hyper (he doesn't believe he should be on the medicine) but as everyone has said there are so many different factors to them. I agree if your child is doing well and you monitor him and are not medicating him just because someone told you too or because you don't want to deal with things then the meds are good.