ADHD Drugs - Yes or No?

The 8-year-old, bright but struggling in school, begins a Ritalin "trial." Soon, though, the child psychiatrist switches the child to Dexedrine sustained release because the capsule can be opened, and the drug sprinkled on a spoonful of apple sauce or pudding. Like many children with ADHD, the boy has difficulty with his "gag" reflex. He won't learn how to "swallow" a pill until he's 15.

His mother gives him one "dose" before he goes to school. At school, a second dose at 1 p.m. should help him focus for the rest of the afternoon, plus have a less frustrating time with homework when he gets home.

He does seem less easily distracted. But his mom notes something else. He's lost his "sparkle."

ADHD drugs. Good or bad?

Some ADHD drugs have been in the news following a handful of "sudden deaths" from cardiac arrest. Last year, the FDA (www.fda.gov) ordered manufacturers of stimulant ADHD drugs to include "black box" warnings regarding potential side effects and risk of death. One such drug that now must carry the warning is Ritalin.

While many believe Ritalin is "overprescribed" - statistics would indicate otherwise. Of the three to five percent of children government experts say have ADHD, only one to two percent take Ritalin. The number of children who have ADHD may even be as high as nine percent, if a study of four U.S. communities is reflective of the total population, which would make the percentage of those taking Ritalin even lower.

Two years ago, the FDA's Pediatric Advisory Committee pointed out two possible dangers regarding Ritalin and another ADHD drug, Concerta. The committee said the drugs might cause psychiatric disturbance and cardiovascular events like stroke and heart attack. After looking into the deaths of 25 people taking "stimulant" ADHD meds like Ritalin, 19 of whom were children, eight months later, the FDA's advisory panel voted for the black box warning - the strongest such warning a prescription drug can carry. Other ADHD drugs required to carry the stronger warning are Adderall, Adderall XR, Methylin and Metadate, and their generic equivalents.

Although it was determined that some with ADHD who died while taking Ritalin or Concerta had pre-existing heart problems or hypertension; the FDA admits that potential risks associated with ADHD drugs have not been adequately studied. The FDA now links a newer, non-stimulant ADHD drug, Strattera (atomoxetine), to suicidal thinking.

Conversely, research shows that, statistically, ADHD drugs are 15 times less dangerous than over the counter anti-inflammatory drugs like Advil, Aspirin and Aleve, and an FDA review found fewer than one case of death or serious injury per 1-million filled ADHD prescriptions. Also, 52 percent of those with ADHD who receive no treatment abuse alcohol or drugs, but a Harvard Medical School study found that medication for ADHD lowered the risk of substance abuse in males by 85 percent. Sixty eight percent of children diagnosed with ADHD will still struggle with the disorder as adults, according to the National Institutes of Mental Health (http://www.nimh.nih.gov/).

The statistics and study are cited by Dr. Rick Sponaugle, medical director and founder of Florida Detox (http://www.floridadetox.com/, 888-775-2770). Dr. Sponaugle is board certfied in addiction medicine and anesthesiology. Important, he says, is to put the recorded deaths in the broader context of how many adults and children take ADHD drugs to help them focus and control restlessness and fidgeting: 2.5-million children and teens; 1-million adults, according to NIMH. The 25 who died spanned a five year time frame (1999-2003), during which another 54 suffered serious cardiac events while taking psychostimulant medications.

In 2005, a small Texas study raised an alarm concerning the use of stimulant drugs to treat ADHD and possible DNA damage. Such chromosomal abnormalities can cause cancer. Teams of FDA researchers are attempting to replicate the study on a larger scale. Investigating the smaller study, the FDA learned that all the children studied showed suspect DNA changes within a very short time. The FDA concluded the findings of the study could not be ignored.

This year, the FDA approved a new stimulant ADHD drug, Vyvanse, that it says is less likely to produce the sensation of other amphetamine-type drugs like Ritalin, and thus have less likelihood of being "abused." However, it carries the same warnings as the older psychostimulants - such as sudden death from heart related problems. Parents are warned to tell the child's doctor about any family history of heart problems or symptoms such as shortness of breath, fainting or chest pain that develop once medication is begun. Psychiatric issues, such as unwarranted suspicion or seeing, hearing or believing things that aren't real, should also be reported. Vyvanse is a once-a-day medication.

Meantime, Yale School of Medicine researchers in the April 20 issue of Cell report the first evidence of a molecular mechanism that significantly alters higher brain "circuitry" in the ADHD brain.

The area of the brain associated with "executive" functions, such as stop and think (impulsivity), is the prefrontal cortex. Yale researchers found that neurons in the prefrontal cortex have ion "channels" that specialize in receiving information. If the brain's prefrontal neurons "short circuit" when, for example, the ADHD person is under stress - the neuron networks disconnect. This impairs working memory, and makes the ADHD brain easily distracted.

The researchers describe ADHD as highly "heritable" (having a strong genetic link), and think those who have it may have genetic changes in molecules that weaken the production of the brain chemical norepinephrine. Norepinephrine helps "reconnect" the information network in the prefrontal cortex.

A drug, guanfacine, from Shire Pharmaceuticals Group has been shown to enhance information receptors in the higher brain in much the same way norepinephrine does. Yale has a license agreement with Shire to develop guanfacine as a treatment for those afflicted with ADHD.

Have questions about a specific ADHD drug? Call the FDA toll free at 1-(800) INFO-FDA (463-6332).