please read this article-
FDA to Warn on J&J’s Concerta Drug
From Bloomberg News
June 29, 2005
Johnson & Johnson’s Concerta attention-deficit disorder drug users have had hallucinations, psychotic behavior, suicidal thoughts and heart complications such as high blood pressure, U.S. regulators said.
The Food and Drug Administration is considering how best to tell doctors and consumers about these complications, the agency said in a statement posted Tuesday on its website.
A panel of FDA advisors will discuss Concerta’s potential complications at a meeting Thursday in Rockville, Md.
Concerta, a once-daily form of Novartis’ Ritalin, is the most prescribed drug for attention-deficit-hyperactivity disorder, or ADHD, according to a Johnson & Johnson website. The FDA said last year that it had Shire Pharmaceuticals Group give doctors warnings about sudden cardiovascular death linked to its Adderall drug for the same disorder.
“The FDA is pursuing additional means to better characterize the cardiovascular risks for all drug products approved for ADHD,” the agency said in its statement.
“Potential options under consideration include population-based pharmaco-epidemiologic studies, long-term safety trials and other targeted CV risk studies.”
Canadian health officials in February ordered Shire to withdraw Adderall, also an amphetamine, because it was linked to at least 20 deaths.
Attention deficit disorder affects about 4.1% of people ages 9 to 17 in any given six-month period, according to the National Institutes of Health’s website.
Johnson & Johnson will not discuss the FDA’s statement ahead of the meeting, said Kathy Fallon, a company spokeswoman.
“It would be inappropriate for us to comment at this point, as we have not seen the complete FDA presentation,” Fallon said.
The FDA said it would add details to the Concerta label about the psychiatric complications.
from LATimes,
http://www.latimes.com/business/custom/cotown/la-fi-fda29jun29,1,1960699,print.story?coll=la-headlines-business-enter&ctrack=1&cset=true
(ellen)
Verification
I have verified this from a number of sources. It also matches with my clinical experience working with kids in foster care. I have seen many cases where kids become agitated or aggressive on stimulants, and they are often diagnosed “bipolar” and given more medications rather than removing the stimulants and seeing if the distrubing behaviors go away. Of course, these are not common side effects, but the studies I have seen suggest that some level of psychotic symptoms are seen in anything from 2-8% of kids taking stimulants at normal doses, so it is not an extremely rare phenomenon, either. I see hundreds of kids taking stimulants, so it is inevitable that I am going to run into this kind of situation from time to time, given those percentages, though it may not be something an average parent will encounter. Unfortunately, many physicians are unaware of or deny these potential side effects. So I am glad that the FDA is doing their job and looking into adding these important warnings to the drugs’ labelling requirements.
I also agree with Victoria that sudden weaning off of any psychotropic drug can be dangerous and should only be done under supervision of a medical professional.
Hope that is helpful!
Re: Warning - If your child is taking Concerta...
I can’t believe that the FDA actually released this information.
Wonder what the ratio is for occurance.
Wonder if they will acknowlege the same for other brands of speed as well.
Wonder how many kids with ADD got themselves into trouble while experiencing these averse reactions.
Not such a long stretch actually. People who take stimulants recreationally often become aggressive and sometimes have hallucinations or psychotic episodes.
surprised
Yeah, I was kind of surprised myself. Maybe they are trying to clean up their act after the antidepressant and Vioxx scandals.
I don’t know the prevalence rates for aggression (it’s probably too hard to define to get good figures), but I am aware that there have been several studies on psychotic symptoms, and the one review I have seen suggests that it is somewhere between 2 and 8% of children at prescribed dosages. So it’s not exactly common, but it is not exactly rare, either. I would have to assume that aggression is more common that that. I certainly have seen several kids kids get in trouble or even lose foster or residential placements as a result.
Re: Warning - If your child is taking Concerta...
Every time this topic comes up I am reminded of a classic science fiction story from the 1950’s that predicted *exactly* this scenario — a whole society wher everyone pops “euph” pills like candy, everything calm and happy except that people occasionally have fits … I am going to have to look this up and post it.
Brave New World
That would be “Brave New World” by Aldous Huxley, where everyone took “Soma” with the rationalization that “a gram is better than a ‘damn’ ”. A chilling novel that everyone should read.
Re: Warning - If your child is taking Concerta...
[quote:487b3e8358=”victoria”]Every time this topic comes up I am reminded of a classic science fiction story from the 1950’s that predicted *exactly* this scenario — a whole society wher everyone pops “euph” pills like candy, everything calm and happy except that people occasionally have fits … I am going to have to look this up and post it.[/quote]
Victoria you must be a teacher.
Re: Warning - If your child is taking Concerta...
Steve — no, the Huxley story is also rather relevant but it isn’t the one I’m thinking of.
concerta
I have a 16 yr old who has been on Ritalin, Adderral and now Concerta. The symptoms at the end of the day have always been tough. Hostile, agressive, “psychotic” behavior. What is left. He doesn’t attend at all off of the stimulants. also has LD. What are other parents doing now?
Tough one!
It is sometimes very hard to know what to do. For me, trading focusing attention for aggression and psychosis is a poor tradeoff. I guess I would probably get him at a calm moment and start talking to him, or better yet, listening to him, about what is coming up in his life and how he wants to live it. There are plenty of “ADHD”-type people who are successful in life without medication, but it requires taking responsibility for understanding your own strengths and limitations and planning your life accordingly. At 16, it is time for him to start coming to grips with the fact that this is HIS LIFE, and he has to decide what he wants to do with it. There is no medical intervention to help him through this.
As for the specifics, some kids like your son do much better in alternative educational environments that are more suited to their needs and interests. For example, would he be interested in getting a GED and going to a trade school? Does he want to become a computer tech? A chef? A graphic artist? What would these professions require of him? Is he a natural salesman? (A lot of ADHD types go into sales!) Does he want to start his own buisness? If you can nail down a GOAL that HE wants to achieve, it can provide motivation to learn the skills of focusing his attention. My oldest wanted a particular job that required about two years of incredibly rigorous training in Florida. Even though he has always been disorganized, clumsy, and oppositional, he was dedicated enough that he learned incredible discipline in order to accomplish his goal. He even had to improve his handwriting - ADHD and left handed, this has always been an incredible challenge for him. But he did it. Because he WANTED THE OUTCOME! That inherent stubbornness of many of our children can be turned to an advantage when he is pursuing his own goals rather than being told what to do all the time. If you can get him taking more responsibility for what he wants to have happen, it will be easier for him to learn the skills to function off the medication.
Hope that is helpful!
concerta problem
Thanks He is very immature and I have been trying to get him to realize it is time to make some decisions. I have him seeing a terapist couselor who is helping him with structure and decision making. I will have to stop that soon d/t finances.
Responsibility
It sounds like he is behind where he should be in emotional development. I have certainly experienced some of the same with my oldest. What I finally had to realize is that I had to let him make some decisions and not protect him from the consequences. This included consequences that came from ME. For example, he expected me to help with what ever he needed but was disrespectful and unappreciative of my contributions, seeing what I contributed as his right rather than a privilege. So I had to make a lot of things conditional. I had to think about what I gave him for free, both purchases and time or effort, and start making all of it conditional on respectful behavior. In your case, there may be some other priorities, but the principle is the same: if you tick people off, they don’t feel like helping you out. So if he doesn’t keep his agreements, lies,cuts school, or whatever, he doesn’t get the usual goodies from you, i.e. rides, money, use of the TV set, whatever it is that he usually gets from you for free. This would include laundry service and cooking.
The other thing that I use a lot with my kids is contracts. Find a time every week that you can meet and discuss whatever issues come up. You can both present issues as long as it is calm and respectful. You lay out the issues, and then ask HIM what the solution is. Get him to agree to what HE will do differently, as well as how you will agree to support him. ave him also suggest whta the consequences are for failing to follow through with the agreement, and what reward he can earn for doing an exceptionally good job. Then you BOTH sign the agreement and post it on the refrigierator. The next week, you meet again and review whatever you agreed to last week. This way, he is both responsible for generating solutions, and accoutable for following through. So if he says, “I hate school!” that’s and OK topic, but he has to decide what he is going to DO about it. Get specific - what do you hate about school? Which teacher or class? Can you drop that class and get a new teacher? Is there something you WANT to study? Is it not offered at this school? Where can we find it? But the one thing that is NOT allowed is for him to say, “Oh, there’s nothing I can do about it.” If he isn’t willing to do anything, then I guess he’s OK with the status quo and should buckle down and do his work. If he doesn’t like it, HE is responsible for planning how to change it. This may include getting a GED and getting a job, taking community school classes or going to community college, joining the Army or the Peace Corps, or whatever. But he has to make a commitment to doing something about his life. You can’t fix it for him.
That’s more than I wanted to get into, but someitmes I get on a roll! I hope that is somewhat helpful. Like I said, there’s no medication for responsibility. The only path I know if is letting him feel the real consequences of his choices. Nagging won’t change anything, but if he is empowered to solve the problems himself, then he can’t trap you into rescuing him. A big part of the trick is not being invested in HOW he solves the problem, as long as the solution is legal and doesn’t hurt anyone else. But it has to be his solution.
Anyway, good luck to you! Hope things work out.
Responsibility
It sounds like he is behind where he should be in emotional development. I have certainly experienced some of the same with my oldest. What I finally had to realize is that I had to let him make some decisions and not protect him from the consequences. This included consequences that came from ME. For example, he expected me to help with what ever he needed but was disrespectful and unappreciative of my contributions, seeing what I contributed as his right rather than a privilege. So I had to make a lot of things conditional. I had to think about what I gave him for free, both purchases and time or effort, and start making all of it conditional on respectful behavior. In your case, there may be some other priorities, but the principle is the same: if you tick people off, they don’t feel like helping you out. So if he doesn’t keep his agreements, lies,cuts school, or whatever, he doesn’t get the usual goodies from you, i.e. rides, money, use of the TV set, whatever it is that he usually gets from you for free. This would include laundry service and cooking.
The other thing that I use a lot with my kids is contracts. Find a time every week that you can meet and discuss whatever issues come up. You can both present issues as long as it is calm and respectful. You lay out the issues, and then ask HIM what the solution is. Get him to agree to what HE will do differently, as well as how you will agree to support him. ave him also suggest whta the consequences are for failing to follow through with the agreement, and what reward he can earn for doing an exceptionally good job. Then you BOTH sign the agreement and post it on the refrigierator. The next week, you meet again and review whatever you agreed to last week. This way, he is both responsible for generating solutions, and accoutable for following through. So if he says, “I hate school!” that’s and OK topic, but he has to decide what he is going to DO about it. Get specific - what do you hate about school? Which teacher or class? Can you drop that class and get a new teacher? Is there something you WANT to study? Is it not offered at this school? Where can we find it? But the one thing that is NOT allowed is for him to say, “Oh, there’s nothing I can do about it.” If he isn’t willing to do anything, then I guess he’s OK with the status quo and should buckle down and do his work. If he doesn’t like it, HE is responsible for planning how to change it. This may include getting a GED and getting a job, taking community school classes or going to community college, joining the Army or the Peace Corps, or whatever. But he has to make a commitment to doing something about his life. You can’t fix it for him.
That’s more than I wanted to get into, but someitmes I get on a roll! I hope that is somewhat helpful. Like I said, there’s no medication for responsibility. The only path I know if is letting him feel the real consequences of his choices. Nagging won’t change anything, but if he is empowered to solve the problems himself, then he can’t trap you into rescuing him. A big part of the trick is not being invested in HOW he solves the problem, as long as the solution is legal and doesn’t hurt anyone else. But it has to be his solution.
Anyway, good luck to you! Hope things work out.
responsibility
great ideas. I have been attempting to do some of these things. The contract is a workable one. Most of the time I am so tired- it just isn’t worth the fight, and I know he knows that. I have been just screaming nd then going to my bedroom and shutting the door.
Getting upset
I can’t stress how important it is for you not to get upset, no matter what. These kids are looking for stimulation. They actually ENJOY arguments and people getting upset. My kids even admitted they thought it was funny when we got angry. Not that they want to upset you per se, but they find it exciting to have loud voices and lots of emotion. I would work on going to your room very quickly the moment you get upset, without an explanation. Maybe, “I need a break,” and then go. It might be a good idea to practice this with someone else. Maybe even your son - you can let him know you need his help, because you know you get upset with him and you are trying to work on this. Ask him to say something annoying and you will practice leaving the area. This actually also helps him think about what he is doing that is annoying. Sometimes they won’t want to participate in this process, in which case get your hubby or a friend to act the role of your son. But however you do it, it is essential that you practice not being upset by his behavior. It’s like giving him a five dollar bill every time you get upset. I know how hard it is, but once I got that part down, the rest became so much easier.
Again, good luck! And remember, he’ll be an adult before you know it. Do your best, and let him learn for himself what the natural consequences are of being obnoxious. He’ll figure it out eventually.
Before taking any sudden action on medications, please be sure to discuss the issues with your doctor. For some medications, sudden cut-off is not recommended. Also please check that the facts are correct, look at the scientific sources.