The use of SSRIs and venlafaxine among children and adolescents in Dutch general practice decreased between 2001 and 2005. A point of concern is the high percentage off-label prescribing of SSRIs and venlafaxine in 2005 as compared to 2001.
In 2001 the general practitioners (GPs) prescribed an antidepressant 732 times to 194 patients under 18 years of age. In 2005 this was 458 prescriptions to 124 patients. Patients who used antidepressants received on average nearly 4 prescriptions a year in 2001 as well as in 2005. More informative is the over all prevalence of antidepressant use decreased from 2.3 per 1000 children and adolescents to 2.0 in 2005.
In 2001 patients under the age of 12 received SSRIs mainly for anxiety disorders and patients above 12 years of age for depression. In 2005 SSRIs were prescribed most often for depression in the younger age group and other psychiatric problems. Other psychiatric problems were mainly hyperactivity and other worries about the behavior of the child. In the older age group (above 12) antidepressants were less often prescribed for depression and more often for anxiety disorder compared to 2001. In the older age group a shift of prescription for other indications than depression and anxiety could also be found. In this age group the same off-label indications appeared more often in 2005 compared to 2001 for the same indications as the younger group.
The off-label prescriptions of SSRIs was almost twice as much as in 2001. The difference was a significant increase (16.7% to 34.4%). For venlafaxine this was also the case, a significant increase in off-label prescription, but mostly for anxiety disorders.
Especially the increase in off-label prescription for hyperactivity and worries about behavior are worrying because the efficacy of SSRIs for ADHD is not established. Another problem with this is that ADHD is to my opinion mostly used for children and adolescents with lack of structure during their upbringing. The decrease of prescriptions of antidepressants for depression is probably due to the recent warnings and attention in the media about possible increase in impulsive behavior and suicidality in adolescents.
Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug’s approved label, most often concerning the drug’s indication. In the United States, the Food and Drug Administration (FDA) requires numerous clinical trials to prove a drug’s safety and efficacy in treating a given disease or condition. If satisfied that the drug is safe and effective, the drug’s manufacturer and the FDA agree on specific language describing dosage, route and other information to be included on the drug’s label. More detail is included in the drug’s package insert. However, once the FDA approves a drug for prescription use, they do not attempt to regulate the practice of medicine, and so the physician makes decisions based on her or his best judgment. It is entirely legal in the United States and in many other countries to use drugs off-label.
Attention-Deficit Hyperactivity Disorder (ADHD), or Hyperkinetic Disorder as officially known in the UK (though ADHD is more commonly used), is generally considered to be a developmental disorder, largely neurological in nature, affecting about 5% of the world’s population. The disorder typically presents itself during childhood, and is characterized by a persistent pattern of inattention and/or hyperactivity, as well as forgetfulness, poor impulse control or impulsivity, and distractibility. ADHD is currently considered to be a persistent and chronic condition for which no medical cure is available. ADHD is most commonly diagnosed in children and, over the past decade, has been increasingly diagnosed in adults.
Pharmacoepidemiol Drug Saf. 2007 Sep;16(9):1054-62.
Antidepressant use and off-label prescribing in children and adolescents in Dutch
general practice (2001-2005).
Volkers AC, Heerdink ER, van Dijk L.