Are Stimulants Safe?

Jenny's story is typical and concerning. Jenny* is an adorable 7 year old girl who was having trouble keeping her mind on her on school work, remembering what she was told, and getting organized. She spent a lot of time daydreaming, not because she wanted to, but because she couldn't help herself. She was sweet, agreeable, hard-working, and getting Fs.

I met with Jenny and her mother several times. I looked at her school work, read reports from her teachers, administered standardized questionnaires. All the signs pointed to Attention Deficit Hyperactivity Disorder, Inattentive Subtype. Unlike children with the usual kind of ADHD, who show a lot of physical hyperactivity and impulsiveness, children with ADHD-I can sit quietly and raise their hands. But they have a terribly hard time paying attention long enough to learn anything.

Jenny's parents and teachers tried every way they could to help her stay focused. They made sure she was well rested and had a nutritious diet. They gave her special seating in school to reduce distractions. They presented assignments in small pieces so she would not become overwhelmed. They kept distractions at home to a minimum, and helped her do her homework in short, concentrated blocks, with lots of breaks. After all of this, Jenny was still having major problems.

So, reluctantly, Jenny's parents decided to consider stimulant medication. We spent nearly an hour talking about methylphenidate, which is the medicine in Ritalin, Concerta, Metadate, and several other brands. Methylphenidate has been in use for several decades. Hundreds of studies have shown it to be helpful for children with Jenny's problem. Millions of children have been treated. I told Jenny's parents that it was one of the safest medications I prescribe.

I started Jenny on a very low dose. It makes sense to start low, because some children are extremely sensitive, and only need a very little. On the lowest dose, it was as if Jenny wasn't taking anything at all. But when we went up a notch, good things happened. Jenny started to be able to stay focused in school. Her work improved. Homework was done in half the time. She felt better about herself. "What do you think about the medicine?" I asked her, "Good, or bad?" She considered a moment, then said in a firm voice, "Good."

This would have been the end of the story, except that it wasn't, because just when we found an effective treatment for Jenny's ADHD-I, the news broke that an advisory committee at the Food and Drug Administration had recommended adding a "black box" warning to methylphenidate, and all related stimulant medications.

The recommendation is based on reports of 25 deaths and 54 serious heart-related events, occurring in several million children and adults taking stimulants. The news reports didn't say if the children were on high doses or low, if they were taking other medications at the same time, or if they were being monitored appropriately. The reports didn't say - because nobody really knows - whether the deaths were caused by the stimulant medication, or were completely unrelated. In a large enough group of people, a certain number of rare events are likely to occur solely by chance.

I think Jenny's parents understand that the risk of her dying or being harmed by the medication are very, very small. But I cannot tell them for sure that the risk is zero. On the other hand, what is the risk to her of daily frustration and failing grades, repeated year after year, if her ADHD-I remains untreated? Neither choice, it seems to me, is risk free. I can help Jenny's parents work through this hard decision, but I can't make it for them.

*Of course, Jenny isn't her real name.