Thirty percent of children with AD/ADHD cannot tolerate taking stimulant medications.

For these individuals, the recent news that Shire is one step closer to gaining FDA approval for its time-released non-stimulant INTUNIV is welcome news.

Intuniv provides a 24-hour evenly released dose of the medication guanfacine. Specifically, guanfacine improves the symptom of the inability to concentrate in children with ADD/ADHD.

When given in conjunction with stimulants, it may also help reduce the aggression and the insomnia normally associated with the use of these drugs.

In fact, some physicians already prescribe it – in an immediate release version and under various brands – to their patients with ADD/ADHD along with other medications. The most common brand used is Tenex. This medication, however, appears not to be very effective at alleviating either the attention deficit or the distractibility seen in children with ADD/ADHD.

Two advantages of INTUNIV

Manufactured and marketed as INTUNIV, though, this form of the medication would hold two distinct advantages over what is currently being used. First, it would be approved specifically for the treatment of ADD/ADHD. And secondly – and most importantly to those whose concentration is low – it would relieve the unevenness produced by the immediate-release version of guanfacine.

Guanfacine works well in improving concentration, but it only lasts several hours, and once the medication wears off attentiveness wanes again.

Recent clinical trials conducted as part of the FDA approval process show that INTUNIV is extremely effective at boosting concentration levels consistently for a 24-hour period

The data the FDA scrutinized included the pooled analysis of results from two double-blind trials. Both of these studies used the teacher based ADHD Rating scale as the criteria for improvement.

One group of children received INTUNIV for the other group received a placebo which contained no medication.

All groups which received the medication scored significantly better in the rating scale than those who received the placebo.

The studies also examined the length of time the medication was effective for these children. Assessments were made at 12, 14 and 24 hour periods following the administration of this drug. Again the data showed significant improvement in the concentration of the children at each of these points in time.

Mild and moderate side effects of INTUNIV

Between 75 and 80 percent of the children, did display mild adverse side effects while taking INTUNIV, most of which appeared within the first two weeks and eventually tapered off. These seemed to be dose-related and included: upper abdominal pain, constipation, dizziness, hypotension, sedation, dry mouth, and drowsiness.

The most common of these side effects were related to sedation.

The medical community has been examining guanfacine for its effectiveness since 2001. That year a study appeared in the American Journal of Psychiatry showing that guanfacine to be a safe and effective treatment for children with ADHD and those who suffer with tic disorders.

The medication, according to the journal article, produced a mean improvement of 37 percent in the total score on teacher-rated ADHD Rating Scale following eight weeks of treatment. This was compared to the eight percent improved for those who received the placebo.

INTUNIV is not a controlled substance — as stimulants are — and does not appear at this time to carry any risk for either potential for abuse or dependence.

The FDA has issued an “approval letter” for INTUNIV, which means that it is prepared to approve the new drug application as soon as certain conditions are met, such as any requests for additional information.

How guanfacine works

Guanfacine works, according to Shire, by acting indirectly on the prefrontal cortex of the brain. Located directly at the very front of the brain and directly below the forehead, the prefrontal cortex controls what are known as the executive functions. This includes the resolution of conflicting thoughts, the choices involved in “right or wrong” and “good and bad” decisions, as well as the prediction of future events.

This section of the brain also governs social control that is it is the area used when we suppress or emotional urges.

Guanfacine is a selective alpha-2A-agonist medication.

Admittedly, the treatment of ADD/ADHD is a highly individualized challenge. Discovering the most effective combination the proper medications and other forms of therapy may mean attempting to use several medications in various combinations as well as varying doses. What is appropriate for one child or adult, may not be either appropriate or effective for another.

Nearly 8 percent of all school-aged children have been diagnosed with ADD/ADHD, according to the U.S. Centers for Disease Control and Prevention. While not normally thought of as a disorder affecting adults, some 4.4 percent of all adults, ages 18 to 44 are affected.

The major characteristic of ADD/ADHD is an inattention or hyperactivity-impulsivity that exceeds those normally observed in most individuals. Official diagnosis of this disorder can not be made until the symptoms have been observed for at least six months.

References:

Pro-drug gets attention,
http://www.sciam.com/article.cfm?id=pro-drug-gets-attention, accessed 11 Jun08

Guanfacine, http://www.depression-guide.com/guanfacine.htm, accessed, 7 Jun 08

Intuniv reduces ADHD symptoms, http://www.realmentalhealth.com/adhd/adhd_toc.asp, accessed 6 Jun 08

Shire Investigational Nonstimulant INTUNIV Showed Significant Efficacy In Reducing ADHD Symptoms, http://www.medicalnewstoday.com/articles/106801.php, accessed 10 Jun 08.

What is prefrontal cortex?, http://www.wisegeek.com/what-is-the-prefrontal-cortex.htm, accessed, 11 June 08

Larry Scahill, M.S.N., Ph.D., Phillip B. Chappell, M.D., Young S. Kim, M.D., Robert T. Schultz, Ph.D., Lily Katsovich, M.S., Elizabeth Shepherd, M.A., Amy F.T. Arnsten, Ph.D., Donald J. Cohen, M.D., and James F. Leckman, M.D. A Placebo-Controlled Study of Guanfacine in the Treatment of Children With Tic Disorders and Attention Deficit Hyperactivity Disorder, http://ajp.psychiatryonline.org/cgi/content/abstract/158/7/1067, accessed 11Jun08

Technorati Tags: Intuniv, Shire, ADHD, ADD, ADHD Medication, ADD Medication

Share This

The link between food additives (i.e. preservatives and food coloring) and Attention Deficit Hyperactivity Disorder (ADD or ADHD) has been speculated for a very long time. There has been research for decades on this. The Feingold Diet has been in existence for many years, and postulates that when you eliminate food additives, ADD or ADHD will improve.

The issue has been that mainstream medical treatment for ADD/ ADHD has generally discounted the role of food additives and diet in the role of treating ADHD.

The interesting fact is that estimates are that up to two thirds of people try some form of alternative treatments for ADD/ADHD - with diet modification as one of the main treatments.

In September 2007, The Lancet published an article about food additives causing hyperactivity. This was a very well designed study, which documented that food additives increased hyperactivity in children who did not have ADD/ADHD. This was irrefutable evidence regarding the connection between food additives and symptoms of ADD and ADHD.

In February 2008, the American Academy of Pediatrics published an article which reviewed the issue and recommends that “a trial of preservative free, food coloring free diet is a reasonable intervention”. You can read more details of this here.

This week, an editorial was published in the British Medical Journal by Dr. Kemp, which suggests that removal of food additives from the diet should be a standard first approach when treating children with ADD/ADHD. This is based on his review of the research.

It seems that the pendulum is starting to swing.

Eliminating food additives and food coloring is on the brink of becoming a mainstream recommendation for the initial treatment of ADD and ADHD.

What Do I Suggest?

I suggest that you review all treatment options with your doctor.
In so far as diet modification, I am all for it as part of the treatment plan for ADD and ADHD. As far as treatments go - there is almost no risk or side effects to this treatment (apart from more time and possibly money to find food alternatives which are preservative free).
I suggest learning more about it - and giving it a try.

The one caution that I have is that elimination diets can be part of the treatment plan, but they may not be the whole answer. Research shows us that in general, treatment of ADD/ADHD needs a comprehensive, multimodal approach (i.e. including behavioral strategies, academic/occupational strategies, medication, therapy etc.). So while I encourage trying elimination diets, I don’t suggest that you then disregard all of the other treatment options which may be helpful.

Please share your thoughts and experiences in the comments below.

Dr. Kenny

Technorati Tags: ADD, ADHD, Food Additives, Elimination Diets, Feingold Diet, BMJ

Share This

A new study was just released which documents that Vyvanse works for Adults with ADD and ADHD.
Vyvanse (lisdexamfetamine) is a new medication for ADD and ADHD, which is currently approved for ADHD in children, aged 6-12.
Shire, the makers of Vyvanse, have applied to the FDA for approval for Vyvanse to be indicated in Adults.
This study documents that it works, and will hopefully help to make this medication more available to adults with ADD/ADHD.
To read more details of this new study, click here.

To read real life stories on whether Vyvanse works, visit this post on my blog - and be sure to scroll down (and please consider sharing your story!).

Dr. Kenny

Technorati Tags: Vyvanse, ADHD, Medication for ADHD

Share This

Does the health care system have your
best interest at heart when it comes
to treating your ADHD?

Here are some shocking facts about ADHD.

* 1.5 Million Adults take stimulant
medication for ADD/ADHD. 10% of them are
over age 50.

* More than 20 Million Children Worldwide
have been diagnosed with ADHD, but only 5-
10% of children suffering with ADHD are
estimated to be diagnosed at all.

For lots more fascinating facts about ADHD,
read my special report, which you can get
here:The State of ADD/ADHD Medication.

* ADHD is poised to become the world’s
leading childhood disorder treated with
medication.

* Global use of ADHD medications rose
threefold from 1993 through 2006.

Are all these prescriptions necessary?

I’m an ADHD doctor. See my surprising
answer in my special report, which you can
get here (hint - the devil’s in the
details):
ADHD Medication Special Report.

* The production of Adderall and Dexedrine,
medicines used to treat ADHD, has risen
2,000 % in nine years

* 2004 revenues for ADHD medication were
over $2.4 billion in the U.S.

The drug companies have YOU in their
crosshairs.

But you are not a statistic.

Your best defense against becoming just an
ADHD number is becoming educated and
learning all you can about ADHD.

You can start with this special free report that I’ve just
released for you:
The State of ADD/ADHD Medication.

Best regards,

Dr. Kenny Handelman, MD FRCPC

P.S.
The fact is, your ADHD treatment plan is
controlled by a health care system that may
not have your best interests at heart. YOU
can take control by educating yourself. Is
that the way it should be? Perhaps not.
But learning about ADHD isn’t as hard as you
think. Take the next step with my fr.ee
report:

Get Your report here:

——————————————
ADD/ADHD Medication Special Report <-- Click Here Right Now
——————————————

Technorati Tags: ADHD, ADD, Medication, Concerta, Adderall, Vyvanse, Ritalin, Strattera, Metadate, Biphentin

Share This

When it comes to ADD and ADHD medication, there have been a number of new warnings that have come out in the past two years. I would suggest that one of the most serious is the concern that ADHD medication can cause heart attacks, strokes, or sudden death.

Ultimately, the current warnings reflect the fact that if someone has a congenital heart defect (i.e. they were born with a physical problem with their heart), have high blood pressure, a family history of sudden cardiac death, etc. then ADHD medications may provide an increased risk, and should either not be used, or should be used with the advice of a cardiologist.

The FDA (US Food and Drug Administration) announced that it will conduct the largest study to date on the cardiac safety of ADHD medications. It will pair up with the AHRQ (Agency for Healthcare Research and Quality). They have a database with over 500,000 children, and adults who have taken ADHD medications. This study will help to establish whether there are measurable cardiovascular risks in people taking ADHD medication. The results will likely take approximately two years to become available.

To read more about this study, click here.

When referring to the ADHD medications, these include: Adderall, Adderall XR, Vyvanse, Ritalin, Ritalin LA, Concerta, Metadate, Daytrana, Methylin, Dexedrine, Focalin, and others.

What should you do about this information? If you have any concerns, contact your doctor, and discuss them. And appreciate the fact that we will know more about the safety of these medications in a couple of years.

Dr. Kenny

Technorati Tags: ADHD Medication, FDA, Vyvanse

Share This

A study was just released today documenting a connection between food additives and hyperactivity. It was published in the prestigious medical journal The Lancet. Unfortunately, one has to subscribe to access the full text of the article. However, you can read a summary of it here - in the press release.

This study tested giving children aged 3 or 8/9 a drink with food additives, and monitoring their behavior. These children did not have ADD or ADHD. The findings documented clearly that certain food additives/preservatives did increase the children’s hyperactivity. These are food dyes, and preservatives which would be found in candy, sodas, and other ‘junk food’.

While this study is important, it does not conclusively show that food additives cause ADD or ADHD. It showed an approximate 10% increase in hyperactivity when children had a significant amount of these food additives.

There is a history of eliminating food dyes and preservatives from the diets of people with ADD or ADHD. The most popular diet is the Feingold diet. This was started in the 70s/80s. You can read more about it here. This diet has been studied rigorously, and at best, it yields significant improvement for ADD/ADHD in 5% of those who follow it strictly.

What is the bottom line if you or your child has ADD or ADHD?

1. Don’t stop medication or other treatments that you are on out of concern that the food dyes may be the complete cause and solution for this condition.
2. The best treatments for ADD/ADHD have been shown to be combination treatments. The ideal treatments incorporate behavioral, parenting, academic strategies as well as medication. If you want to add a diet component to that, you can, but just keep it as one of the treatments in the combination.
3. I recommend that each parent of a child with ADD or ADHD, or each adult with ADD or ADHD should consider eliminating these food additives and dyes for a short time and seeing if it makes a difference. Talk to your doctor about this, and review it as an experiment. If you are inclined to do this - go for it. If you are not - don’t. There is no imperative here, and the research data don’t show that it is a must for the treatment of ADD or ADHD.

Most of us feel that we live in a society with too many chemicals, additives and preservatives. This study shows that in children without ADD or ADHD, there is a mild increase in hyperactivity with food additives and preservatives. This does not prove that ADD or ADHD is caused by these chemicals, nor does it show that by stopping these chemicals will ADD or ADHD be treated.

This study is quite important, and hopefully more well designed studies will help to shed light on this important issue. If you want to try to use these insights to help in your treatment of ADD or ADHD, speak to your doctor or health professional.

To read Time magazine’s perspective on this issue, visit here.

Technorati Tags: ADD, ADHD, Food Additives, Hyperactivity, The Lancet, Feingold Diet

Share This

A research study was just published in the medical journal ‘Sleep‘ which reports on a study of children with attention deficit hyperactivity disorder (ADHD) and poor sleep efficiency. It documents that a measure of vigilance improves when these children use the medication methylphenidate.

The researchers split 37 children with ADHD into two groups - good sleepers and poor sleepers, based on testing. They then found that the poor sleepers had a significant improvment in their awareness and vigilance on the neuropsychological test called the CPT (continuous performance task) when they took methylphenidate.

Methylphenidate is the active medicine in the following ADHD medications:

• Ritalin
• Ritalin LA
• Ritalin SR
• Concerta
• Metadate CD
• Biphentin
• Daytrana
• Focalin
• Methylin
• Rubifen
• and others…

Sleep problems can be very common in individuals with ADD or ADHD.
The American Academy of Sleep Medicine recommends the following:

Experts recommend that children in pre-school sleep between 11-13 hours a night, and school-aged children between 10-11 hours of sleep a night.

Your child should follow these steps to get a good night’s sleep:

* Follow a consistent bedtime routine.
* Establish a relaxing setting at bedtime.
* Get a full night’s sleep every night.
* Avoid foods or drinks that contain caffeine, as well as any medicine that has a stimulant, prior to bedtime.
* Do not go to bed hungry, but don’t eat a big meal before bedtime either.
* The bedroom should be quiet, dark and a little bit cool.
* Get up at the same time every morning.

Parents who suspect that their child might be suffering from a sleep disorder are encouraged to consult with their child’s pediatrician or a sleep specialist.

Technorati Tags: ADD, ADHD, Sleep Medicine, Ritalin, Medicine for ADHD

Share This

A new study was reported on in the Syndney Morning Herald, discussing how Melbourne researchers have done brain scans to show how differently children with ADD or ADHD’s brains process information. The story is here.

The article reports:

Researchers at Flinders University in Adelaide tracked the brain activity of 150 children and teenagers with attention deficit hyperactivity disorder (ADHD) to build a neuro-cognitive profile of their behaviour.

The researchers found that children with ADD or ADHD without their medication - struggled with memory and avoiding distractions. With their medication, they improved.

On this blog, I have wondered what is going on in Australia with ADD/ADHD. There seems to be a significant bias against this disorder. One of my blog readers posted a very insightful comment on my previous blog post, helping me to understand why new reports seem so biases against ADD/ADHD in Australia.

That is why I am happy to see that a good brain study was done, demonstrating that children in Australia with ADD or ADHD have brain differences, which improve with their medication. This is an important study to help to clear up misconceptions about ADD/ ADHD.

Well done!

Share This

The American Academy of Child and Adolescent Psychiatry just concluded its annual scientific meeting in San Diego.

An important study came out regarding the use of Daytrana, the methylphenidate patch - which is sometimes called the ‘ritalin patch’.

Click here to see a video on how daytrana works.

While the Daytrana patch is recommended to be used for 9 hours per day, this study showed that the patch can be used for less than that.

If a child has the patch put on later in the day - for example on the weekend - it can still be taken off at the regular time. This means that the child can have the benefit of the long acting patch even if it is applied at 11 am or later, but when it is taken off on time, there is less chance that it will cause sleep or appetite troubles.

To read a full account of this story, click here.

Share This

At the recent scientific meeting of the American Academy of Child and Adolescent Psychiatry, a study was released which documented that Strattera improved ADHD and Reading Disorder (dyslexia). I will summarize this study here, but if you want to read the full report, please visit here.

In this study, children aged 10-16 were treated with Strattera for their ADHD for 16 weeks. There were two main groups - children who had ADHD alone, compared to children who had ADHD plus a Reading Disorder (Dyslexia).

At the end of the study, there was approximately a 50% improvement in ADHD symptoms in both groups.

The interesting difference came when looking at improvement in reading scores. The ADHD and Reading Disorder group had a 2 year improvement in their reading scores, compared to a 17 month improvement in the ADHD group.

Although Strattera is not approved for the treatment of Reading Disorder/Dyslexia, these are encouraging results.

Share This