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Vol.22, No.4, April 2006 - Editor's Commentary: Why are stimulants facing the dreaded "black box"?

Here's an odd paradox: the recent FDA advisory panel's vote in favor of imposing a "black box" warning on stimulant medications may end up producing a beneficial effect - but for the wrong reasons.

To review the recent events: the FDA convened an advisory panel because it was looking for research strategies to unravel the association between stimulant and medications and sudden death or serious cardiovascular problems in patients taking the medications. Data indicated that there were 25 sudden deaths between 1999 and 2003 in patients being treated for Attention Deficit Hyperactivity Disorder (ADHD) with these medications -19 of which were children or adolescents.

The FDA recognized that further study is needed to answer a number of critical questions, such as: 1) Is the number of sudden deaths associated with these medications greater than what would be expected by chance? 2) If so, do the drugs cause the problem themselves or are other factors directly responsible? and 3) Are there special populations with medical or other conditions that put them at unusually high risk?

Instead of a research strategy, the panel advised (by an 8-7 vote) that the "black box" warning be instituted immediately and applied to all stimulant medications (Ritalin, Adderall, Concerta, Methylin and Metadate; Strattera, another common ADHD medication, is not a stimulant and therefore excluded). The FDA is not obligated to follow the advisory panel's recommendation and the conventional wisdom is that they will likely be more cautious in their response.

Abundant evidence exists for the efficacy of stimulants over placebo and other medications in treating the symptoms of ADHD - more so than for any other type of medication used to treat any childhood psychiatric disorder.

Over 200 controlled trials in the past 50 years, including rigorous, NIH-funded studies with large samples and longitudinal design, have documented a clear benefit for approximately 2/3 of the children with ADHD. For example, the MTA Study found that 35% of ADHD children responded to behavioral therapies, 55% responded to Ritalin, and 65% responded to a combination of Ritalin and cognitive behavioral therapy - all in comparison to 25% who responded well to standard community treatment. Side effects of stimulant medications are well known (gastrointestinal symptoms, headache, decrease appetite and sleep disturbance primarily) and generally not considered dangerous.

So why the dramatic and unusual approach to a group of drugs that are widely used, effective and overall quite safe?

I believe the panel is reflecting society's concern with the widespread use and rapid increase in prescriptions for stimulant medications. By one account, almost 10% of 12 year old boys are now taking stimulants. The largest increase in stimulant use in the past three years, however, has occurred in adults, where prescriptions have increased 90%. The assumption, supported by everyone's anecdotal experience, is that not all the 2.5 million children on stimulants actually need them. In addition, it is widely recognized that too often the medications are started after only a cursory work-up, that treatment plans do not also include the nonpharmacologic components that are essential for best results, and that medication monitoring may be too casual.

The pharmaceutical industry has not helped their cause by suppressing negative results of industry-sponsored trials and seductively marketing quick fixes directly to consumers. Some feel it's as if the pharmaceutical industry won't let up until most of the population is on a psychoactive medication. The Scientology movement, which has little use for any medications or mental health professionals, preys on such concerns and in fact sponsored most of the negative testimony at the advisory panel hearing.

As was clearly seen when the "black box" warning was applied to SSRI antidepressants, such a warning will immediately lead to a significant reduction in the number of prescriptions written for stimulant medications. Primary care physicians, whose psychopharmacologic training is limited, will be especially wary of initiating stimulant treatment for ADHD. Parents' anxiety levels will rise and they will be more questioning about the diagnostic workup, the comprehensive nature of the treatment plan, and potential side effects of the medications. Even if the risks motivating the "black box" warning turn out to be tiny and avoidable, the benefit from more careful medical practice and more informed consumers may be substantial.

However there is also a downside to using a "scare tactic" rather than a scientific approach: many children may miss out on an effective treatment that, at best, can turn their lives around. The next few months will test our wisdom and commitment to doing the right thing for children.

The Brown University Child and Adolescent Behavior Letter, April 2006
Reproduced with permission of John Wiley & Sons, Inc.
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Phone 1-888-378-2537
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