A single mother of three young boys of my acquaintance once vowed that she would go to jail before she would abide them being prescribed the attention deficit hyperactivity disorder drug Ritalin. She believed that shoot-from-the-hip diagnoses of attention deficit disorder, attention deficit hyperactivity disorder and trendy mental disorders du jour unfairly stigmatize boys whose high energy and impulsiveness was in times past dismissed simply as "boys being boys."
She felt that the over use of psychiatric medication was child abuse compounded by drug abuse. She worried about side effects, and felt that psychiatric medication was a gateway to lifelong drug dependency, an emotional growth inhibitor and a profit center for psychiatrists and drug companies.
Worse, she saw it as an easy out for parents (and other authority figures) too self-absorbed or too lazy to sacrifice the time and energy required to teach children self discipline and proper behavior. Not to mention that she thought it a tad unseemly for influential adults to be lecturing children about the evils of mind altering drugs while simultaneously prescribing mind altering drugs to control children's behavior.
Recent studies by the U. S. Food and Drug Administration seem to justify her concerns. In March, an advisory committee to the FDA denied approval of Cephalon Inc.'s experimental drug, Sparlon, to treat attention deficit hyperactivity disorder in children and adolescents. The Psychopharmocologic Drug Advisory Committee expressed concern about Sparlon's link to a rare but serious skin reaction in one 7-year-old boy and psychiatric problems in others. The committee ruled that Sparlon, while effective, is not acceptably safe and needs more study. Cephalon has submitted new information which it hopes will allay the FDA's concerns.
A Cephalon spokesman said that the panel's decision reflected the FDA's general concern over drug safety as much as a specific one over Sparlon. That may be true, but so what? Many believe that close oversight is warranted.
This month, British drug manufacturer GlazoSmithKline PLC sent a letter to physicians warning them that the antidepressants Paxil and Paxil PC may increase the risk of suicide attempts in some adults, particularly those aged 18 to 30. Glaxo's letter comes 18 months after the FDA put "black box" warnings on all antidepressants stating that they increase the risk of suicidal thinking and behavior in children and adolescents under 18 years old. "Black boxes" often lead to fewer prescriptions and sales.
In March, the FDA's Pediatric Advisory Committee cautioned doctors and parents to be far more vigilant about rare but serious psychiatric side effects such as horrific hallucinations, aggression and suicides by children.
The drugs include Shire PLC's Adderall XR, McNeil Pharmaceutical's Concerta, Novatis AG's Ritalin, Eli Lilly's Strattera and Focalin XR, and Sparlon. Currently, Strattera carries a warning label discussing risks of suicide. Adderall XR carries warnings about psychosis and sudden death in people with heart abnormalities.
But what really attracted the researchers' attention were negative psychiatric side effects in patients with no prior history of psychosis-related events who used the medications properly. Kate Gelperin, an FDA drug-safety expert, reported that as many as six percent of children using ADHD medications properly might experience a negative psychiatric side effect.
There were reports of hallucinations and mania among children as young as 7. At least 10 deaths - six from suicide - were reported on children using Concerta between 2000 and 2005, although not all were directly blamed on the drug. At least four suicide deaths were reported on children using Adderall or Adderall XR.
Said one expert, "These adverse events seem to be over and beyond 'unmasking' what the child was going to do anyway. In case upon case of what we read, it really struck all the reviewers."
Rashes, hallucinations, suicides? What's that old adage about the cure sometimes being worse than the disease?
But what if my friend was right? What if at times ADHD is less about hyperactive children than about parents unwilling or unable to cope with the (admittedly challenging) demands and responsibilities of parenthood?
If that were so, (don't forget, my friend was speaking as a mother), wouldn't (shouldn't) it be child abuse per se to prescribe mind altering drugs with potentially serious or fatal psychiatric side effects to their children, no matter how challenged...or challenging?
