Parents and ADHD Patients Caught in the Middle As FDA Committees Disagree

Millions of parents have read the recent headlines that the FDA has recommended warning labels on medications used for the treatment of ADHD. These headlines have caused a lot of fear among parents, wondering if the medications that their children were using to help their ADHD might be dangerous.

We always want parents to make decisions based on facts, not on fear. So here are the important details of a disagreement between two committees. Knowing the whole story will surprise you.

On February 9, 2006, the FDA's standing Drug Safety and Risk Management Advisory Committee was tasked for the morning to study ADHD medications to see if there was a link between the stimulant medications and an increased risk of sudden death or serious cardiovascular problems from taking the medications. The FDA also tasked the Committed with considering ways of studying the drugs without putting patients at risk.

This FDA advisory committee is a standing committee that studies all types of medications and products. Members of the DSRM committee have a broad range of experiences and education, and report on a range of agenda items through the year. The information below comes from sources ranging from news reports to the FDA Advisory Committee's own website.

As the DSRM committee considered ADHD medications, and after some discussion, the Committee took action and voted 15-0 to recommend that the FDA require a "medication guide" for parents and patients to read for all prescriptions of ADHD medications. Good thinking and common sense applied.

However, some members of the DSRM Committee got off task immediately and began to debate the link between the medications and 25 reported deaths of patients who had been taking ADHD medications over a four-year period of time (1999-2003). Many of these patients had pre-existing heart problems.

The FDA's Dr. Kate Gelperin, who is a medical officer in the Office of Drug Safety, joined the conversation and reported to the Committee that an analysis of the reports of death and injury suggest a possible link between the drugs and cardiovascular problems, but that it is not "conclusive" that a link exists, it is just a possible link.

Nor is it clear that there is actually an increased incidence of death or serious injury from taking ADHD medications. "This is really a question that we would like to have answered," said Dr. Gelperin, referring to the DSRM Committee's reason for meeting.

An previous FDA review found less than one death, or serious injury, per 1 million prescriptions filled for ADHD medications.

Some members of the Committee then changed the subject, stopped talking about safety, and charged that ADHD medications are seriously "over-prescribed."

According to sources, Cardiologist Steve Nissen, a well-respected consultant to the Committee, gave his opinion that there was an out of control growth in the rate of ADHD medications being prescribed to adults, and stated, "We have to elevate the level of concern" about the "out-of-control use of drugs that [may] have profound cardiac effects."

Dr. Nissen pushed for a "black box" warning label on all ADHD medications. Over-prescription to adults, rather than safety, now became the issue under debate. The "black box warning," normally a response to a safety issue, would now be recommended to slow the rate of growth in prescriptions to adults.

The committee apparently never considered the possibility that the reason for the increase in the use of ADHD medications may be that they actually work, and that people might refill their prescriptions for the medications because they may actually improve the quality of their lives.

After debate, the Committee voted 8-7 to recommend the most serious type of warning, a "black box" warning label, for ADHD medications because of "potential cardiac risks" (not mentioning that they were really more concerned about the rate of growth in the prescription of the medications with adult patients).

March 23, 2006. Following the actions of the Drug Safety and Risk Management Advisory Committee, the FDA had asked their Pediatric Advisory Committee to also study the issue, and they met to make their recommendations.

The Pediatric Advisory Committee rejected the recommendation from the Drug Safety and Risk Management Advisory Committee that medications used to treat ADHD should have the strongest type of warning, called a "black box" warning.

The Pediatric advisory committee did recommend adding more information to the labels of these medications for doctors, patients, and parents.

The FDA must now consider the recommendations of both advisory committees and determine what, if any, action to take regarding ADHD medications. No one knows for certain how many children and teens are prescribed these medications for ADHD, but estimates range from 2 million to 3.3 million in the United States alone, so this is an important decision to make.

It is important to understand that all stimulants have potential side-effects, including loss of appetite, increased heart rate, and less commonly a risk of seizure, heart attacks, hallucinations, and more. People with heart conditions should not take or use any stimulants, from caffeine (Starbucks coffee, Mountain Dew, Diet Pepsi, or even chocolate) to medications.

The medications can be controversial. For example, Health Canada had pulled Adderall from the market in Canada last year, but then found that there really was very little evidence linking the medication to these serious problems. Adderall was returned to the market after a few months. The Health Canada report can be read online.

Strattera already has a "black box" warning in the U.S. that it may cause suicidal thoughts in children. It also carries a similar warning in Canada.

About the debate, it is important to understand that the Drug Safety and Risk Management Advisory Committee is composed largely of Risk Management specialists. None of the members treat children or teens for ADHD, and only know of the issue second hand. According to the FDA Advisory Committee web site the Committee is composed of 2 Internal Medicine MDs, 1 Ambulatory Care and Prevention MD, 6 PhD's or equivalent in Pharmacy or Pharmaceuticals, 1 Lawyer, 1 Pharmaceutical Industry Representative, 0 Pediatricians, 0 Psychiatrists, and 0 Family Practice Docs.

After the DSRM Advisory Committee voted 8-7 for the "black box" warning on ADHD drugs, the FDA asked the Pediatric Advisory Committee to examine the same issues.

The Pediatric advisory committee was composed largely of Pediatricians and Child Psychologists who actually treat children for a living, and often prescribe medications for ADHD patients. A list of the members of this Committee can be found at the advisory committee website.

The Pediatric Advisory Committee concluded that, "Potential episodes of psychosis, aggression and cardiac events with attention deficit drugs in children do not warrant a black box warning."

The committee felt that the cardiovascular events were not of a similar risk in ADHD children as adults, except for those with cardiovascular abnormalities. The committee also declined to endorse a black box for psychiatric events, including aggression, and risk of suicide, according to the FDA Advisory Committee's web site.

Also parents should understand that the News Media loves the debate, and loves the idea that a medication that is being prescribed to perhaps 3 million children and teens might be forced to wear a "black box" warning on the label. This is the kind of news that sells newspapers.

Physicians, patients, and parents must understand that there are risks to stimulant medications. But they are rare. Stimulant medications do have their place, and when needed should be considered. Stimulant medications should be prescribed with care, and parents should understand that they are not toys, vitamins, or over the counter remedies. The medications used for ADHD are powerful, usually effective, but can sometimes cause serious problems.

There are alternatives that can also be effective without the potential of dangerous side-effects, including diets for ADHD (see http://newideas.net/adhd/adhd-diet for an example), the nutraceutical Attend's specific treatment strategies ( http://newideas.net/adhd/attend ), and EEG Neuro-feedback training.

We have always recommended trying the alternatives (1) diet and (2) Attend strategies before considering medications. Together they are statistically as effective as medications in the treatment of ADHD. Should these interventions not provide the patient with the benefits that he needs, the patient should then consider the available medications for ADHD.

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The above article is for information and educational purposes, and is not to be considered as medical advice. Consult with your physician on these issues.

Douglas Cowan, Psy.D., is a "retired" family therapist. He has worked with ADHD children and their families since 1986, and has researched and written about ADHD extensively. He is the clinical director of the ADHD Information Library at "newideas dot net," helping over 400,000 parents and teachers learn more about ADHD each year. Dr. Cowan also serves on the Medical Advisory Board of VAXA International of Tampa, FL., is President of the Board of Directors for KAXL 88.3 FM in central California, and is Pastor of Family Ministries at his church in California.

A Basic Guide to ADHD For Parents

If your child has been diagnosed with ADHD, you probably feel as though you have been plunged into a strange new world filled with big words and strange medications that doctors swear will work miracles. Despite the fact that nearly 10% of all children suffer from ADHD, there is astonishingly little information readily available on the facts about ADHD for parents.

There are two things you need to understand about ADHD before going any farther.

1) ADHD is not a learning disorder, and

2) It is not your fault your child suffers from ADHD.

Many resources on ADHD for parents dance around those two points, leaving parents feeling as though they have somehow failed their child and they are doomed to spend the rest of their lives lagging behind their peers. ADHD is classified as a developmental, behavioral and neurological disorder that results in the impairment of the child to perform at a developmental level that corresponds with their age.

Toddlers have a notoriously short attention span, but toddlers with ADHD will not lose this short attention span as they grow older. Instead, they will continue to have difficulty controlling their impulses, releasing their energy in an appropriate manner and focusing on specific tasks (particularly those they find unpleasant) for any length of time.

ADHD is a chronic condition, and it is one for which there is no cure. Your child will not "outgrow" ADHD; however, as they grow older they will learn how to better control their symptoms. The precise cause of ADHD is still unclear. Resources on ADHD for parents list a variety of factors that are suspected to contribute to ADHD, including (but not limited to):

" Genetics

" A chemical imbalance of neurotransmitters

" Diet

" Differences in brain structure

The effects of ADHD are easily recognizable. Children with ADHD are restless, prone to fidgeting in their seats and playing with their fingers and toes when they are able to sit at all. They have a very difficult time focusing on one task, often rushing through work or wandering away in the middle and leaving it incomplete.

The most difficult symptom of ADHD for parents, however, is the lack of control children with ADHD have over their actions and responses. Children with ADHD seem to have an almost manic energy, screaming, running and shouting at improper moments and making statements that are rude, tactless and hurtful without seeming to realize that their actions have consequences. These symptoms impact children both academically and socially, making normal development in both areas very difficult.

ADHD is treatable, and as a parent you have many options for the treatment of your child's ADHD. There are numerous medications on the market that have proven extremely effective in children with ADHD, including Ritalin and Adderall. A recent study showed that children who were treated with dietary supplements responded as effectively as those treated with Ritalin without the harmful side effects, and there are numerous herbal and other non-prescription alternatives available.

Behavioral therapy is often the preferred method of front line treatment of ADHD for parents. Through behavioral therapy your child will learn how to calm their mind and body to think clearly and therefore respond appropriately to situations, eliminating the impulsive behavior that can make ADHD a living nightmare for parents and children both.

There is nothing wrong with your child. ADHD is a very common disorder among children, and it's one that can be treated and controlled to offer your child a best-odds chance at a spectacular future.

For more information on surviving, treating and helping yourself and your child succeed with ADHD, check out the ADHD Survival Guide.

What Parents Can Do To Help An ADHD Child

No doubt that, as a parent, being told that your youngster is an ADHD child will unleash a torrent of often conflicting emotions within you.

You may feel that things have suddenly become a little 'skewed', and that you are no longer in charge of your life or that of your child, either.

You will perhaps feel a terrible, but nevertheless natural, surge of sadness, frustration and remorse.

In some ways, you will probably even blame yourself for the fact that your child has been diagnosed an ADHD child.

In the midst of all of these conflicting feelings and emotions however, it is very important not to lose sight of one crucial fact.

That is, it is not the end of the world and that the fact that your child is now 'officially' an ADHD child does not change them or your one jot!

You must accept the fact that many, many kids that are diagnosed with ADHD (or the associated ADD) will ultimately be seen to have gifts and talents that far outweigh their 'disability'!

There are quite a few ways in which you can help your ADHD child to nurture and utilize his (or her) 'special' talents, and thus deal with ADHD.

The first and perhaps most critical step is to know exactly what it is that you are dealing with, by doing your research and becoming familiar with everything there is to know about ADHD.

Quite simply, the more that you know about what being an ADHD child means to your youngster, the more you will be able to help them. You will be better equipped to help your child, and understand their particular problems.

You would also be able to teach yourself about some of the more popular or common ADHD treatments, and be better prepared to face whatever might happen next. In this way, you can position yourself to help your ADHD child to cope better with their situation, to teach them more about their condition, and to answer any questions or queries that they might have.

Being informed will be useful in readying you to work with your child's medical professional to try to manage their disorder successfully, too.

In consultation with your Doctor, you will also have to give very serious consideration as to whether you can accept having your child medicated. This will obviously depend on several factors, such as the degree and severity of your ADHD child's 'affliction', and will also be decided at least to some extent by your own individual opinion.

At the end of the day, such a decision is an entirely personal one that only you can make.

Some parents have maintained that the administration of drugs or medicines give their ADHD child the best chance of leading as normal a life as possible and that, therefore, such drugs are a good option.

For others, medication is a very definite 'last resort', something to which they really do not want to turn until all else fails.

However, no matter which path you should choose to take, you need to make that decision based on knowledge and certainty, rather than on guesswork!

Even if you should decide that using medications is the right way for you and your child to go, you should not lose sight of the fact that you still need to manage your ADHD child's behavior as well.

By teaching them the basics of what constitutes acceptable behavior and what does not, you will prepare your child for life, teaching them the skills that they will need in order to become efficient and productive in later years.

The strategies, plans and rules that your child must adhere to must come from you. It is absolutely crucial that a children suffering from ADHD has clearly defined limits set on their actions and that they must be taught to adhere to those guidelines.

You must be willing to encourage your child at all times, no matter how difficult their behavior may sometimes become. You should be their strongest supporter, and provide them with everything that they might need to succeed.

Whether they are at home or in school, it is your job to help your child to grow into a confident, self-assured and happy person.

Rather than focusing or concentrating on the negative side of them being an ADHD child, you should strive to recognize their potential and try to help them to do the same. Make sure that they are always aware of the extent to which you value and love them.

An ADHD child is often susceptible to some degree of depression and low self-worth, so you need to be aware of, and prepared for this eventuality.

You must be ready and able to take the necessary actions to deal with this situation, never forgetting, of course, that you can always seek expert help should the situation demand it.

Finally, is at all possible, never allow either yourself or your ADHD child to become isolated and cut-off from others. If possible, seek out and join a good support group to meet and interact with others in the same situation as you.

It is very often true that sharing a problem does lessen its burden upon you, and the advice that you can get from a parent who has been through a similar situation to yours is probably the best advice you can ever hope to receive.

Do not be mislead into thinking that having an ADHD child in the home is the end of the world.

Do not allow yourself to treat it as such, and the quality of life for both you and your ADHD child will be immeasurably enhanced.

The author has compiled a FREE handbook of some of the best writings about ADHD from the last ten years, and you can access your personal copy from [http://www.SteveCowan.com/ADHD/book.html] He also analyzes the #1 ADHD Management Program on the net at [http://www.SteveCowan.com/ADHD] and blogs on ADHD & ADD related matters at http://SteveCowan.com/add