Black Box Scare: Are ADD Drugs Safe?

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

Let's keep some perspective: Aspirin is known to be more dangerous to adults than stimulants.

Edward Hallowell, M.D.

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.

This article comes from the April/May 2006 issue of ADDitude.

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