ADHD Drug Warnings

[blueangel]

Just got this news release and thought I'd share. I know some of you have mentioned you have ADHD, so this might be of interest:

FDA News
FOR IMMEDIATE RELEASE
P07-26
February 21, 2007
Media Inquiries:
Sandy Walsh, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events
The U.S. Food and Drug Administration (FDA) today directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.

"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER). "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns."

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:

Adderall (mixed salts of a single entity amphetamine product) Tablets
Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
Concerta (methylphenidate hydrochloride) Extended-Release Tablets
Daytrana (methylphenidate) Transdermal System
Desoxyn (methamphetamine HCl) Tablets
Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
Focalin (dexmethylphenidate hydrochloride) Tablets
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
Methylin (methylphenidate hydrochloride) Oral Solution
Methylin (methylphenidate hydrochloride) Chewable Tablets
Ritalin (methylphenidate hydrochloride) Tablets
Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
Strattera (atomoxetine HCl) Capsules
The draft Patient Medication Guides for each product can be found at http://www.fda.gov/cder/drug/infopage/ADHD/default.htm. For more information please visit www.fda.gov.

####

[AlexMack]

I understand the concern and actually wrote about it for a class of mine. What needs to be emphasized is that the cardiac problems and deaths occur in patients with underlying cardiac conditions and/or risk factors.
Another important detail is that ADHD is caused by altered brain chemistry...the voices, paranoia and mania may be a part of that. ADHD is typically co-morbid with other mental disorders.
Having said that, the benefits do outweigh the risks when taking these medications as long as the right drug and dosage is achieved. It annoys me to no end when parents describe the drugs as 'cocaine for kiddies' when it's a medically controlled and prescribed substance carefully monitored by physicians. We're not creating 5 year old junkies here, we're allowing and helping these children to function normally. I only wish I'd received my diagnosis in childhood.

Blueangel, your thoughts?

[Drolefille]

The odd thing is that Strattera is completely different from the rest of those medications. I'm not certain why it would have the same risks as the others. It was originally developed as an anti-depressent and is a Neurepinephrine reuptake inhibiter. (Failed to help depression but works on ADD, many antidepressents do as well) The others are neural stimulants.

And ditto on wishing that I was diagnosed in childhood.


ETA: Oh and realistically, this is just adding a line to the tiny tiny print insert in your bottle of pills. Not putting a big ol' WARNING sticker on it or anything.

[Kevin]

I've got what most would consider to be a pretty severe case of ADHD. For me, the behavior modification route was far, far better than the drugs. Until I have severe physical conditions (e.g., high blood pressure) I'll forego any sort of medication regimen. I think that I probably suffered a little for my choice in HS and undergrad. Not enough to keep me out of law school, and since getting into law school, I've been outperforming the vast majority of my 'normal' classmates.

I know my route probably isn't what most would choose, but I figure that ADHD is just an aspect of what I am. So long as there was no serious risk of harm, I never really saw the utility in medicating myself in order to try and repress some aspect of my personality.

It's a choice between the patient (possibly through their parent or guardian) and their physician. The above study is something which could probably have been inferred from the above medications. Most of them are psychostimulants. A side effect is an increased heart rate. Increased heart rates lead to cardiac events as far as I know.

[blueangel]

Centaur:

At this point, I have no opinion. I don't know enough about the drugs to comment. I was just passing on the news release because I thought it might be helpful to those who use the medication. Thought they might want to discuss it with their doctor.

[Drolefille]

Originally Posted by Kevin

I've got what most would consider to be a pretty severe case of ADHD. For me, the behavior modification route was far, far better than the drugs. Until I have severe physical conditions (e.g., high blood pressure) I'll forego any sort of medication regimen. I think that I probably suffered a little for my choice in HS and undergrad. Not enough to keep me out of law school, and since getting into law school, I've been outperforming the vast majority of my 'normal' classmates.

I know my route probably isn't what most would choose, but I figure that ADHD is just an aspect of what I am. So long as there was no serious risk of harm, I never really saw the utility in medicating myself in order to try and repress some aspect of my personality.

It's a choice between the patient (possibly through their parent or guardian) and their physician. The above study is something which could probably have been inferred from the above medications. Most of them are psychostimulants. A side effect is an increased heart rate. Increased heart rates lead to cardiac events as far as I know.

That's why I was wondering at the inclusion of Strattera on that list.

I think if I'd been diagnosed earlier I would have had more options with regards to treating my ADD. It didn't hurt me academically really until college, although even then I was muddling through, but socially and mentally I've struggled with being different sometimes. Now, though perhaps an ADD coach would be effective, I can't pay for it and I'm not sure how well my insurance would cover it.

[Kevin]

An ADD coach? Really?

I've never even heard of that. I think you can probably self-adjust. It's just a matter of slowing yourself down and being more deliberate with the things you do and say. It'll be easier for you than for most because you're certainly above average in the intelligence department.

[valkyrie]

The fact that speed = increased cardiovascular risk has always been obvious to me. Like anything, it's matter of weighing the costs and benefits and figuring out what's best for you or your kid.

[Dionysus]

Originally Posted by Kevin

I think you can probably self-adjust. It's just a matter of slowing yourself down and being more deliberate with the things you do and say. It'll be easier for you than for most because you're certainly above average in the intelligence department.

That's one of the root problems of ADHD. Depending on the form and severity, some with ADHD simply don't have self-adjust controls and lack the foresight to be deliberate with things.

[MysticCat]

Originally Posted by Dionysus

That's one of the root problems of ADHD. Depending on the form and severity, some with ADHD simply don't have self-adjust controls and lack the foresight to be deliberate with things.

Especially when they're elementary-age school kids. Those kinds of things often come with some maturity.

Our approach to drugs has basically been this: without some medicinal support, our son, who has ADHD and High-Functioning Autism (relatively mild, but giving him extra challenges nonetheless), has little capability to work on the bahavior modifications and strategies that will help him cope in the long run. With medicinal support, he has the opportunity to learn the skills that will, we hope, enable to him to get along fine without drugs as he gets older.

[AlexMack]

Originally Posted by Kevin

I've got what most would consider to be a pretty severe case of ADHD. For me, the behavior modification route was far, far better than the drugs. Until I have severe physical conditions (e.g., high blood pressure) I'll forego any sort of medication regimen. I think that I probably suffered a little for my choice in HS and undergrad. Not enough to keep me out of law school, and since getting into law school, I've been outperforming the vast majority of my 'normal' classmates.

I know my route probably isn't what most would choose, but I figure that ADHD is just an aspect of what I am. So long as there was no serious risk of harm, I never really saw the utility in medicating myself in order to try and repress some aspect of my personality.

It's a choice between the patient (possibly through their parent or guardian) and their physician. The above study is something which could probably have been inferred from the above medications. Most of them are psychostimulants. A side effect is an increased heart rate. Increased heart rates lead to cardiac events as far as I know.

Looking back, I have had classic severe ADHD throughout my entire life. Fluctuating grades, impulsivity, name a symptom and I've had or still have it. When I started ritalin, I didn't notice the difference but everyone around me did. I was told I slowed down, even my speech, I could remember engagements and actually make it places on time. It's not a wonder-drug but it works well enough for me that I'm still trying out different medication methods to figure out the best path.
My biggest problem is hyperfocus and well...I've been told I should be a lawyer because I can make these massive leaps and connections where others will not see them in terms of logic. The downside is that while I can form a highly logical argument, an overload of information means shutting down instead of working with my mind. An example that comes to mind is my paper on abortion where I was asked to argue both sides of the issue. There was so much to talk about I couldn't get started because I had no clue...I even cried. I handed the paper in two weeks late.
Kevin, I envy your coping strategies and I would love to know how you've modified your life to make it through college and into law school. I'm no idiot, as with most ADHDers I have above-average intelligence, but I've hated and struggled with school from day one and I believe it's because of a lack of structure and self-discipline plus a learning disability (dyscalculia). In fact, I'd love to know how other ADHDers on here cope with everyday life.

Me? My room is a literal pigsty. If I need to study I must listen to non-instrumental music OR Coldplay. I HAVE to write lists of things I must accomplish during the day because the internet is a huge distraction for me.
I survive on flashcards. I rely on others to provide me with structure and discipline because I am fairly incapable at times. (Who was late for every new member meeting? That would be me! Who forgot to pay dues until 3-4 weeks into the semester? That would be me. It goes on...)

I wish I could be medication-less, but after life with meds, it's hard to go without. As I've gotten older, my memory has worsened considerably.

Also, Kevin, a fair number of children do grow out of their disorder. Do you feel this may have occurred with you?

Right, post over. That there, ladies and gents, is the ramblings of a mad woman with ADHD I hope it made some sense.

[Kevin]

I can tell you -- no, I didn't grow out of my disorder. My wife would back me up there. When I'm not making an effort to slow down, be deliberate, etc., it's very obvious. It's not so much a "coping strategy" type thing. That would be too clinical an approach. It's more that I just constantly strive to be professional, organized, clean, etc.

It's not perfect. My office/home are immaculate. My car? It's a pigsty.

I can definitely agree with you as to memory. Mine is terrible. You know what though? I work that to my advantage sometimes. The "I forgot" excuse (even if I didn't) still carries a lot of water for me where otherwise, it might not

I never forget big things (anniversaries/birthdays/deadlines), but I'm not so great with social engagements, whether I or my wife are responsible for my dinner each evening, etc. You can't be perfect. Perfect, in my opinion is boring. I think ADHD is part of what I am. It's part of my life. If I'm kicking butt in the grades department, I can't really argue with success. Sure, if I were taking some sort of medication, I might be closer to the top of the class. Sure, I might remember things, but I wouldn't be as "me" otherwise.

[Drolefille]

I've always done well in school unless I bump into authority. AKA I cannot handle stupid teachers. Never could. My biggest issues were keeping up with ongoing projects. I don't journal well, and I do everything at the last minute. My coping strategies until college were: ... well... cram for everything and just barely get it all done. That's about it.

I finally went to my Dr. and told her I had ADD (gee I was right) and now when i'm on my medication steadily I do slow down, and I am more motivated to work on longterm "projects" instead of individual assignments. My biggest issue is that Strattera is not like the speed meds. So it has to work its way into my system and missing a dose seems to be more common with me than my brother (who's on concerta).

In class I always have an extra notepad for drawing, my classmates love to come see what I did after class. If my mind is really racing I try to have something to do with my hands, silly putty, knitting... something. I'll write out song lyrics to something that's calming if there's nothing better for me to do. I study in front of the TV because it's easier to focus that way. I've also walked around the house doing things with a book in my hand my entire life. Keeps my mind busy or something. I can read and turn pages with one hand

Kevin, an ADD Coach is kind of "in" right now. It's like "life coaching." They help you get things organized and figure out how to compensate and deal with your ADD in everyday life. Making schedules and that sort of thing too. It's like a step or two down from therapy and a step or two up from self-organization. (Not that one's better or worse)


Anyway, I'm lucky that my particular challenges have worked well with school for the most part. I've also had very understanding teachers. It is interesting though that no one ever picked up on it with me, even though my younger brother was diagnosed several years before me. He however was struggling in school and running circles in his room (literally), I got good grades and read a book. Reading is the one thing that I'm almost never distracted from. Well, reading for fun
/yay for doing a presentation on adult ADD last semester
//damn i rambled.

[AGDee]

I was talking to a mom today who is getting all kinds of flack from her family about putting her son on ADHD meds. He is in his second year of kindergarten because he hasn't been able to stay seated or focus on learning at all. The school wanted him in special ed classes because, during his second year of kindergarten, he still wasn't learning anything or able to follow the rules because of his extreme impulsivity. He has been on the meds for two months and has completely caught up academically and is surpassing other kids in his class. Yet, her family is still getting on her case about her medicating him.

While it is being overdiagnosed and medications are being unnecessarily prescribed, there are kids who NEED it to function. Nobody would question a parent who gave their diabetic child insulin.

I have a cousin who was tested at an IQ of 165. He was on ADHD meds early in life and graduated from high school two years early. While in college, he developed a heart problem and went off all his ADHD meds. Now, he's not able to finish college because he simply can't focus. He's a cashier at Meijer's now. Oh, his dad? He managed to finish his MBA without ADHD meds, but couldn't work a desk job ever, so he's worked on an auto line his whole life.

Some of the meds I'm on for Crohn's have really awful side effects.. from cancer to heart problems, to highly increased risk of infectious disease and chronic pancreatitis and liver failure. I have to be monitored carefully because of all this and that stinks, BUT without it, I would have starved to death by now, or would be living on IVs.

Risk benefit analysis is the key.

[PiKA2001]

There's the DSACDAD drug Havidol that didn't make this bad boy list.

http://www.havidol.com