If there's anything scarier than a black box warning slapped on the side of your
prescription drug package, it's a black box warning slapped on the side of your
12-year-old's prescription drug package.
Parents were understandably alarmed last month when a U.S. Food and Drug
Administration advisory committee recommended such a warning on Ritalin and
other stimulants used to treat attention deficit hyperactivity disorder in
The black box--named for the ominous black border that surrounds the text of the
warning--is the strongest label the FDA requires, reserved for drugs whose
potential side effects are serious enough to warrant second thoughts about risks
So a sigh of relief is in order after a second FDA committee decided this week
that Ritalin and its cousins, Adderall and Strattera, didn't need such a serious
warning after all. What they need is an accurate but measured warning, in plain
English. The FDA says it will likely adopt the second recommendation.
The drugs, prescribed last year to more than 3 million youngsters in the U.S.,
can cause cardiovascular problems in adults and children. There have also been
reports of hallucinations, usually involving snakes, insects and other creepy
crawlies, but so far no true link has been established.
Those rare side-effects are cause for concern, but not alarm. The FDA's
pediatric advisory panel decided the drugs didn't need a tougher warning --just
a clearer one. That means explaining the possible side-effects in understandable
terms, counseling parents to watch for them and encouraging them to talk to
their doctors about halting treatment, if necessary.
In October 2004, the FDA ordered black box warnings on antidepressants, warning
that they might increase the risk of suicidal behavior in children and
teenagers. Since then, many of the parents of such troubled youngsters have been
paralyzed by competing dangers: Should they leave their kids on the drugs and
risk the side-effects? Or give up the drugs and risk the consequences of
untreated mental illness? For those parents, there are no easy answers.
In the case of stimulants, though, mental-health experts argued that leaving
ADHD untreated could cause more harm than the potential for side-effects.
Millions of families who despaired of a normal life or education for their child
have been rescued by Ritalin. That doesn't mean the red flags can be ignored.
Children taking the drugs should be monitored closely, and the FDA should
continue to study the risks. For now, though, the FDA's non-alarmist tone seems
to hit the right note.