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Sunday, Jul 12, 2009
The failure to test the effects in children of routinely prescribed drugs has resulted in at least one death. How many kids will die before drug companies take steps to ensure their safety?
May 23, 2002 | Ten-year-old Shaina Dunkle had been taking the psychiatric drug desipramine (trade name, Norpramin) for her attention-deficit/hyperactivity disorder (ADHD) last year, when she suddenly fell and had a grand mal seizure. She died within minutes in the arms of her mother, who watched helplessly as her daughter's life ended. Shaina's autopsy revealed no other cause for her death than the desipramine. Her parents, in the small central Pennsylvania town of Smithtown, struggled privately with tremendous guilt and anger until they began to learn more about their daughter's treatment. Now, the outrage they feel about the circumstances of Shaina's death has prompted them to go public with their concerns.
Shaina Dunkle should never have been on this drug. In the late 1980s, child psychiatrists promoted desipramine for the treatment of ADHD. But by the mid-1990s, reports of seven sudden deaths of children taking the medication in appropriate doses for ADHD led most doctors to abandon desipramine for other, "safer" medications. According to Shaina's parents, desipramine was offered to them as a once-a-day drug that, unlike Ritalin, the most commonly prescribed medication for ADHD, had no abuse potential. However, when used properly Ritalin has not been implicated in sudden death (the one reported exception was a 14-year-old boy who died suddenly after taking the drug for more than 10 years). The Dunkles were never told of the increased risk for this catastrophic side effect related to desipramine.
Desipramine is just one of many drugs that received FDA approval for treatment of an adult condition -- in this case depression -- but was then, and apparently is still now, used in children for a variety of behavioral and performance problems. Once the FDA approves a drug, it can be used with a physician's prescription for any purpose, a practice called off-label prescribing. Many doctors prescribe many medications off label for children, but none do it as frequently as child psychiatrists.
Child psychiatrists have long been viewed as the ultimate authorities in the evaluation and treatment of children's emotional and behavioral problems. Today, however, these doctors appear to be pushing pills exclusive of anything else. In fact, a recent survey of child psychiatry practices by the Yale Child Study Center, published in the Journal of the American Academy of Child and Adolescent Psychiatry, revealed that only one in 10 children who visit a child psychiatrist's office leaves without a psychiatric drug prescription.
Even leaders within the community of child psychiatrists, doctors like Michael Jellinek, the head of Harvard's child psychiatry department, and Peter Jensen, former director of the head of the children's section of the National Institute of Mental Health, have publicly expressed concern that there is not enough evidence of the effectiveness and safety of these medications to support their widespread use for kids.
And they should be concerned. About 4 million children take either Ritalin, the only psychiatric drug adequately researched for use by children, or an equally well-tested equivalent like Adderall, Concerta, or Metadate. About 1.5 million children take adult antidepressants like Prozac for a variety of problems. Hundreds of thousands are on various other adult medications: clonidine, a drug originally approved for adult hypertension, is prescribed to take the edge off difficult behavior caused by ADHD, especially in the late afternoon or evening, when taking a stimulant will keep the kid up all night. Depakote, a drug tested in adults for epilepsy, is the latest prescriptive drug "in fashion" for treatment of the burgeoning number of children diagnosed with bipolar disorder. Risperdal, a "new generation" anti-psychotic drug, is prescribed for children primarily to control aggressive behavior.
