by John M. Curtis
(310) 204-8700

Copyright February 10, 2006
All Rights Reserved.

ore popular than vitamins, stimulants used to treat attention deficit hyperactivity disorder—a common childhood behavior problem—have been fingered for potentially life-threatening side effects, including strokes, heart attacks and sudden death. Voting to require drug makers to post “black box” warning labels, an FDA advisory panel found the class of drugs potentially dangerous for children, adolescents, and especially adults predisposed toward cardiovascular disease. Millions of children and adults are given stimulants for attention problems with hyperactivity. Drug safety experts expressed concerns about how the ubiquitous use of these drugs contribute to life-threatening cardiovascular complications. While the exact percentages of deaths from ADHD drugs remain unknown, experts fear widespread use could contribute to countless numbers of heart problems.

      Stimulants have been prescribed for decades to treat hyperactivity and attention problems. Pediatricians routinely prescribe stimulants to wayward youth when behavior problems interfere school performance. Powerful stimulants like Novartis' Ritalin, Shire's Adderall, McNeil's Concerta and Eli Lilly's Strattera are routinely prescribed for treating behavior symptoms associated with attention deficit disorder. When children present behavior problems, physicians readily oblige parents with commonly prescribed anti-hyperactivity drugs. About 2.5 million children and 1.5 million adults currently receive stimulants for a wide variety of behavior problems. Prescriptions for adults increased 90% from 2002 to 2005, attesting to wide acceptance among family doctors that adult attention deficit disorder [with or without hyperactivity] represents a legitimate medical diagnosis.

      Scientific explanations for how stimulants improve attention and lessen hyperactivity remain murky. Stimulants, like benzadrine and Dexedrine, have been used to treat hyperactivity since the 1930s. When Elan Pharmaceuticals introduced Ritalin in 1956, it was marketed as a miracle cure for childhood behavior problems, promising improved school performance and reduced juvenile delinquency. How many patients suffered adverse cardiovascular side effects is anyone's guess. Stimulants were frequently prescribed as appetite suppressants, and, less commonly, for low energy and narcolepsy. Only recently has adults been treated with stimulants for attention and behavior problems. “This is out-of-control use of drugs that have profound cardiovascular consequences,” said Steven Nessen, a cardiologist and member of the Food and Drug Administration's advisory panel.

      Millions of children, teenagers and young adults have taken Ritalin and other stimulants for hyperactivity since the 1950s. While the FDA received reports of about 25 deaths and larger numbers involving heart attacks and strokes, it's difficult to ascertain whether predispositions caused the problems. “We have got a potential public health crisis. I think patients and families need to be made aware of these concerns,” said Nessen, supporting the use of “black box” warning labels. Nessen has concerns that go beyond possible adverse cardiovascular mishaps in vulnerable populations. Nessen raises the very real possibility that anti-hyperactive medications are currently over-prescribed. Government figures show that up to10% of all 10-year-old boys take these drugs for a various behavior problems. Whether current adverse reactions warrant “black box” warning labels is another story.

      Drug makers have good reason to contend that anti-hyperactivity drugs have a long track record of safety. Over fifty-years of prescribing stimulants for hyperactivity hasn't turned up an epidemic of cardiovascular mishaps. “You don't want to over-scare people and make them not use an important drug,” said Dr. Robert Temple, a top policy official at the FDA, balancing proper caution against unnecessary hysteria. “But you don't want people using drugs if they don't have too,” raising the more important issue behind the excessive use of stimulants to treat common childhood behavior problems. When exasperated parents complain about behavior problems, well-intentioned physicians reach for the prescription pad. Medications have their place but can't replace sound parenting skills, or, for that matter, emotional, situational or personality problems plaguing adults.

      All drugs should be prescribed to treat specific symptoms, whether medical or behavioral. If adverse side effects outweigh the expected benefits, then the FDA must do its job, either (a) posting “black box” warning labels or (b) taking drugs off the market. No matter how convenient, physicians must resist the temptation to prescribe powerful drugs when alternatives offer the best solution. Fifty-plus years of prescribing stimulants to treat attention deficit problems and hyperactivity haven't turned up obvious cardiovascular complications. Of the millions of patients treated for hyperactivity, only 25 deaths or unknown numbers of strokes and heart attacks don't constitute a pressing health risk. "Black box" warning labels won't stop physicians from over-prescribing stimulants like Ritalin to manage common behavior problems, where other options are more appropriate.

About the Author

John M. Curtis writes politically neutral commentary analyzing spin in national and global news. He's editor of OnlineColumnist.com and author of Dodging The Bullet and Operation Charisma.

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