ADD’s Black Box Scare

There is no hard evidence linking recent sudden deaths to stimulants, which are still more safe than aspirin.

Reviewed on April 6, 2017

I was stunned to read that an advisory panel recommended that the FDA apply its most stringent warning to Ritalin and other stimulant medications commonly used to treat attention-deficit disorder. The ominously named “black box” warning is affixed to drugs deemed especially dangerous. But these drugs have been in use for nearly 70 years. Why a black box warning now?

I’m a psychiatrist who has ADD. I have been treating ADD in children and adults for the last 25 years and have written books on the subject. I am also the father of two children who take stimulant medication for ADD.

No new data

I felt sick as I feverishly read the official statements, looking for the terrible new data that justified this recommendation. But there was none. The recommendation was based on an upsurge in stimulant prescriptions, which the panel found alarming when coupled with 25 reports of sudden deaths in people taking the medications – even though there was no proof that the stimulants caused the deaths. In other words, it isn’t that the drugs are more dangerous than we thought, it’s that they’re probably being too freely prescribed. A federal survey found that nearly one in 10 12-year-old American boys takes a stimulant.

Stimulants have been used since 1937 to treat what we now call attention-deficit disorder or attention-deficit/hyperactivity disorder. Used properly, they have been proved safe and effective. Like all medications, stimulants used improperly can be dangerous, even fatal. But let’s keep some perspective: Aspirin is known to be more dangerous to adults than stimulants. And penicillin is estimated to kill 500 to 1,000 people each year. Yet we rightly revere aspirin and penicillin, while cautioning that they be used with care. No black box warning needed.

Gaining some perspective

So what about those 25 sudden deaths? First, it is not at all clear that because a person dies when taking a certain medication, the drug caused the death. Nor is there evidence that the number of sudden deaths is statistically significant – meaning more than random. There are 30 unexpected, sudden deaths per year per 1 million children between the ages of 10 and 14. More than 1 million children of that age take stimulants. Of the 25 deaths cited by the FDA panel, 19 were children. Therefore, we cannot conclude that stimulants raise the risk of sudden death.

One may argue that the reported deaths represent only a small fraction of actual deaths, or that side effects such as strokes and heart attacks are overlooked. Good point – let’s do studies to determine the true risks. But if the data don’t yet warrant a black box warning, why scare the daylights out of everyone?

I think the FDA panel reacted so strongly because so many people are being put on stimulants that it is hard to believe a proper work-up is being done on each of them. This objection makes more sense. Most primary care doctors don’t have enough time to do the in-depth work-up a diagnosis of ADD requires. Some doctors are writing too many prescriptions for stimulants; others refuse to write any at all. Most neglect to offer treatments that do not involve medication. Stimulants are not always effective or necessary.

Promising developments

Getting enough sleep, lots of physical exercise, and eating right help with ADD (and everything else). And it’s important that people with ADD get help in learning to organize themselves and that they get plenty of positive human contact. In addition, there are promising developments. For example, UCLA researcher Susan Smalley has shown that using mindfulness-type practices to treat ADD in teens and adults may improve behavioral symptoms and attention ( ).

Another new treatment that has shown good, albeit uneven, results is cerebellar stimulation. This involves exercises such as juggling, balancing on a wobble board, and standing on one leg with eyes closed, all of which are designed to stimulate a region at the back of the brain called the cerebellum. I am biased: My son has benefited greatly from cerebellar stimulation, and I now consult for a company that offers the treatment. Nutrition, biofeedback, and neurofeedback also hold promise in treating ADD.

There is a benefit to the FDA panel’s alarm. It means that such new approaches will get the attention they deserve. But the most important intervention needs no more study. It is the understanding that ADD can be a gift – if it is unwrapped properly.

Lives transformed

People with ADD (as well as those with dyslexia, depression, bipolar disorder, or anxiety disorders) usually have extraordinary talents that get buried under troubles and disappointments. The most powerful help is the identification and development of their strengths. I have seen this, more than any other intervention, transform patients’ lives.

Every treatment for ADD should involve a program aimed at identifying and promoting talents and interests, whatever they might be. Viewing ADD only as a disorder creates far worse disorders: shame, loss of hope, and giving up on dreams. That’s what really deserves a black box warning.

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