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.

6 Ways ADHD Therapy Can Help Patients Lead a Normal Life

Are you frustrated with the effectiveness of medication given for the symptoms of ADHD? Are you or someone you love still having difficulties coping with daily activities? Does it affect social, educational, or employment opportunities that most people take for granted? Then, you need to know 6 ways ADHD therapy can help patients lead a normal life.

With ADHD alternative therapy, many patients can learn to deal with the potentially debilitating disorder. The 6 major therapies to be considered are:


Psychotherapy
Behavior therapy
Family therapy
Social skills training
Support groups
Parenting skills training

The idea is not just to mask the disorder with medication, but treat the patient and the entire family with any ADHD therapy that will lend to a more normal and enjoyable life. So, it is a good idea to know what each treatment has to offer, and make informed decisions with health care professionals.

Psychotherapy

In simple terms, this ADHD alternative therapy is basically venting emotions and ideas with a professional to help. Children and adults can discuss ways to deal with their symptoms, the negative behaviors that must be dealt with, and anything else that may be bothersome.

Behavior therapy

For safety and sanity reasons, parents and teachers need to have the tools necessary when managing an ADHD child becomes necessary. Without this ADHD therapy, children especially will have a difficult time learning how to live peaceably with others.

Whether it means timeouts for unacceptable behavior, rewards for good behavior, or some other technique, this is an important aspect of ADHD therapy. Otherwise, when the medication is simply not effective enough, or it begins to wear off, a child may get out of control and do self harm or hurt someone else.

Family therapy

For the sufferer, living with ADHD can be extremely frustrating. It makes the responsibilities and pleasures of everyday life so difficult. But, the individual with the disorder is not the only one who is miserable. Parents and siblings must learn how to cope with ADHD and the inevitable hurdles that can create family tensions.

Social skills training

Often times, kids with the disorder do not understand the difference between acceptable behaviors and those that are not. Even if they do, the task of behaving in a manner that is proper in public is extremely difficult. ADHD therapy can help teach children with the disorder how to recognize when they are getting out of control and act appropriately at school, home, church, or any other social situation.

Support groups

Another ADHD alternative therapy is not necessarily only for the individual with the disorder, since support groups can also be for parents and family members living with a loved one who makes life nothing less than challenging.

Support groups are a place to talk about the frustrations of the disorder in an environment where others will totally understand. In addition, it is also a place to share triumphs and ideas that may make living with the disorder easier for someone else.

Parenting skills training

Finally, comprehensive ADHD therapy also includes parenting skills training. Understandably, raising a child with special needs is far more challenging than taking care of the average child. Every aspect of life is just that much more difficult for children and their families. When the simple act of sitting still is almost impossible, it is no wonder that learning and other areas of life are adversely affected.

If you or someone you love suffers from the disorder, do yourself a favor and check into any ADHD therapy available to you. Why struggle needlessly with problems that may be addressed and resolved with an ADHD alternative therapy. With the knowledge and the skills to cope, life will be more rewarding and productive for everyone in the home.

Tina Matsunaga is a freelance writer for home-based businesses, Internet marketers, and professionals around the world. She enjoys working at home while raising 2 children. She holds a BA in English and secondary education from Regis University.

For more information on alternative therapies for ADHD, please visit http://www.curing-adhd-naturally.com

Sleep-disordered breathing is common but hard to detect in pediatric patients

ScienceDaily (June 5, 2010) ? According to new research presented on June 5, at the 19th Annual Meeting of the American Academy of Dental Sleep Medicine, an estimated 18 percent of pediatric patients in a University of North Carolina-based study were at risk for sleep-related breathing disorders (SRBD). Importantly, pediatric risk was not associated with any demographic or craniofacial characteristics, as it is in adults, making it difficult to detect.

The study included 100 children between seven and 17 years of age, of which 43 percent were male and 57 percent were female. The group was 73 percent Caucasian, 10 percent Hispanic, nine percent African American, five percent Asian, and two percent American Indian.

Researchers used a previously validated survey, the Pediatric Sleep Questionnaire (PSQ), to estimate the risk of SRBD. Each patient's parent or guardian completed the PSQ for his or her child. A score of 0.33 suggested risk for SRBD. Results indicated that 18 percent of the participants were at risk for sleep-disordered breathing.

Orthodontic records including information on craniofacial characteristics were obtained for each patient. The researchers looked for an association between risk for SRBD and craniofacial features. They also examined the effect of gender, race, age, and body mass index on SRBD risk. No significant associations were found for either demographic or craniofacial characteristics.

"We were surprised that our findings suggested that the risk for pediatric sleep disordered breathing was as high as it was, since our review of the literature suggested that the prevalence of pediatric obstructive sleep apnea was one to three percent. We speculate that either our sample size was too small, or that additional factors contribute to the condition in children," said principle investigator Kristen Fritz.

Early diagnosis of pediatric SRBD is critical because signs and symptoms often lead to misdiagnosis of sleep disorders as other clinical conditions such as attention deficit disorder or attention deficit hyperactivity disorder.

SRBD are serious conditions with major health-related consequences for children. This study alerts health care providers to the fact that it is not possible to predict risk for SRBD by looking at certain demographic or craniofacial characteristics in children.

"Screening tools such as the PSQ, or specific inquiry about suspected risk factors such as snoring, sleepiness or behavioral problems, offer dentists who treat children an opportunity to recognize, educate and refer pediatric patients that may be at risk for SRBD," said Fritz.

Editor's Note: This article is not intended to provide medical advice, diagnosis or treatment.

Story Source:

The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by American Academy of Sleep Medicine, via EurekAlert!, a service of AAAS.

Note: If no author is given, the source is cited instead.

View the original article here