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Millions of parents have read the recent headlines that the FDA has recommended warning labels on medications used for the treatmentn 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://www.newideas.net/adddiet.htm for an example), the nutraceutical Attend’s specific treatment strategies (http://www.newideas.net/attend.htm), and EEG Neuro-feedback training (http://www.eegspectrum and others).

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 http://www.newideas.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.

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“Get down from the table top right now! What are you doing? Floors are for standing on, tables are for eating. You need a time out, young lady. You go to your room and think about how you have been acting today.”

So little Mary, 4, goes to her room with a sulky look on her face, but is quickly lost in a game with her dolls and toys. When her mother comes to tell her that she can come out, she is so engrossed in playing that she barely looks up, completely forgetting why she was sent to time out in the first place.

So, does time out work for children?

Yes, but only when it is age appropriate (one minute for each year of age) and then followed by a discussion at eye level of why the action was unacceptable. There has to be some conversation or connection to the actual event or misbehavior for it to be used as a teaching tool. It has been my experience that the consequences need to be tied in some tangible way to the mistake in order for the discipline to become long lasting. Perhaps a more effective teaching discipline would be to have Mary scrub the table and chairs.

When the room is in chaos, the kids are fighting, the phone is ringing, the potatoes are burning and the baby is crying all at the same time, the natural reaction is to explode. Even the act of seeing the bike in the driveway, again, is enough to make the blood boil and the steam come out of our ears.

However, I am convinced that parents need to step back at times and reflect on the fact that they are teachers who are training the next generation, instead of giving in to the impulse to scream, smack or threaten.
Step back to see a new perspective.

It is better by far for you to give the child some warning and say ” I am so angry right now that I am afraid I will say or do something that would make both of us sorry, so I am going to go in the bedroom and calm down for a few minutes. Meet me in the living room in 15 minutes and we will discuss it. But, in the meantime, I strongly suggest you not bother me and that you spend the time thinking about solutions to the problem.”

When you feel tense, try saying calming things to yourself aloud: “Things will work out, it is not worth a stroke” “I want to have the misbehavior stop, but not damage my child’s spirit” “That was a rotten thing for her to have done, but she is not a rotten child” “She is a good child who made a bad choice” “Is this worth ruining the evening over?” “This too (or two, in the case of toddlers) shall pass.”

Relax somewhat by taking a deep breath to the count of four, hold for the count of four and release to the count of four, while you are thinking or saying aloud “Be calm”. Now, do it again at least three times. You can feel your muscles unwind and your head clear somewhat. You will feel more in command of your voice and your actions.

Focus on solutions, not excuses

In 15 minutes (often you don’t get the luxury of one minute for each year of age, but wouldn’t it be nice?) you will have calmed down some and the child will be ready to offer solutions. Do not allow him to offer excuses, only solutions. Allowing him to own the problem and the consequences makes it a much more effective learning experience for both of you. Taking time out before a discussion gives both the parent and the child time to regain some perspective and come up with a much more meaningful solution than one handed out in a moment of anger.

An example from one mother

Sandy, Mother of 3 shared with a parenting class some excellent advice on dealing with children;

“Many times when the kids seemed to have ‘an attitude’ that I knew could rapidly lead to a confrontation, I made them go in the kitchen and have a peanut butter sandwich or some cheese and crackers and then meet me in 20 minutes to discuss things. Frequently, they were simply hungry or thirsty and needed to get some protein and carbohydrates in their body to regulate the blood sugar. It is amazing how many arguments were forestalled by a full belly. Finding out that active 11-13 year old boys needed 3,000 calories a day to operate and grow, explained why they were cranky a lot!”

Take an adult time out to regroup

You have my permission to take a time out whenever you need it. Children need firm and kind discipline and we can’t offer that when we are angry or out of control ourselves. A few minutes of reflection, prayer or deep breathing can give us a new prospective on life and the crayon drawings on the living room wall.

You do the most important work in the world and twenty years from now, it will be a funny family story about Mary on the dining room table. In reflection you will both realize that tables can be washed or even replaced, but close relationships and respectful guidance are priceless.

Judy H. Wright© 2005 www.ArtichokePress.com

Judy H. Wright is a parent educator and PBS consultant whose passion is working with Head Start staff and parents as well as child care providers. She wants to encourage a climate of mutual respect and nurturing to all. She salutes those who work with children, either in their home or as a profession. For more a complete listing of articles, books, cd’s, workshops and speaking engagements, see www.ArtichokePress.com. Be sure and sign up for the free ezine, “The Artichoke, finding the heart of the story in the journey of life.”

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Yellow Moon lay awake as the fading stars crept across the smoke hole. False dawn lightened the eastern sky while wakening birds shattered the silence. The day’s list of chores filled her mind, an occasional elusive thought keeping her from completing the tally.

There were the constant problems of finding dry wood for the fires, the filling of their three precious water jars and the endless strips of pemmican to be smoked for the winter provisions. Quietly, Yellow Moon rose from her bed of bearskin covered pine needles, left the teepee to gather a supply of beef jerky, a pouch of dried berries and nuts. The basket of food would keep Gray Wolf strong for his hunt.

Only one more full moon would pass before the snows came. Yellow Moon hated to leave this beautiful spot they called home all Spring and Summer. Soon gathering enough firewood would cost Gray Wolf a day’s journey and the best hunting lay a fortnight to the North.

From his perch in a larch tree, Gray Wolf waited for a sign of deer. A light snowfall hid his scent and muffled the sounds of the forest. He began to stretch his muscles, stiff from the hours on the tree branch far above the ground.

At last, he spied a young buck and two does browsing on tree bark only ten man lengths away. Their path would take them within easy striking distance. The arrow twanged against the bowstring, bringing instant death to the buck and a promise of survival to his family. Many moons south on the shores of a wide river a special spot lay waiting for the new Blackfoot home.

As much as Yellow Moon loved their home, a sense of adventure provoked exciting thoughts of the coming journey. A comfortable space on the travois lined with rabbit fur would secure the safety of their two winter old daughter, Little Feather. The tribe’s herbalist told her of the many large fish living in the river and of the rich soil for the growing of crops. The bag of precious seed in its protective wrapping would ravel in a place of honor.

As Yellow Moon spun the bow to start the new day’s fire, wild stories of white men’s wind ships seen sailing upstream failed to mar her vision. Only the dangers of hunger and sickness hovered in her thoughts. A burning spark in her mind kept alive her will to survive, for in her body grew the seed of the future chief of the Blackfoot tribe.

Fiction can be a great vehicle for thought.

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Planning a baby shower for the expectant mother in your life is incredibly exciting and lots of fun. However, planning a baby shower can also be time consuming, and it can be hard to get everything done in the time allotted.

One of the most important things that must be attended to is choosing the best invitations to let everyone know of the upcoming celebration of life.

==The Baby Shower Invitations Are The Key ==

After all, in a way the invitations to the baby shower are the key to everything else involved in the shower. After all, if no one knows about the baby shower, no one will be able to attend.

Luckily, there are so many kinds of invitations for baby showers that it should be fairly easy to find one that is right for you.

==Picking Appropriate Baby Shower Invitations ==

Invitations to a baby shower can be as simple or as fancy as you want to make them. It is important to choose a baby shower invitation that is appropriate to the style of the mother to be.

==The Internet ==

One place to start the search for the best invitations to any baby shower is on the internet. The internet is a great way to search for hundreds of different invitations in a very short period of time.

There are a number of web sites that are dedicated to baby shower planning, and they often have some excellent resources for invitations to your baby shower. In addition, there are a number of online printers with their own web sites, and they often have a number of excellent sample invitations for you to choose from.

== Your Local Print Shop And Office Supply Store ==

If you would rather choose the local flavor for your baby shower invitations, chances are your local print shop or office supply store has a good selection of invitations that would be perfect for any baby shower.

== Print Your Own Invitations ==

Another great option is to print your own invitations to the baby shower. There are a number of kits, available at both local office supply and software stores and on the internet, which allow you to create beautiful invitations using only your home computer and your deskjet printer.

Just be sure to buy plenty of ink for your printer. Printing your own invitations gives you a great amount of freedom and allows you to be extremely creative when creating and printing those invitations.

Shaunta Pleasant is a professional writer and editor on baby shower topics. Visit my site to learn more about planning the perfect wedding at http://www.baby-shower-gala.com/baby_shower_invitation.html

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