Regulations for mental health drugs prescribed to minors

Prescribing Psychotropic Medications to Minors

It is every parent's worst nightmare: the drugs intended to cure a child kill him or her instead. Since the development of drugs like Prozac and Paxil, drugs classified as SSRIs (selective serotonin reuptake inhibitors) have been increasingly used to address depression in patients that otherwise would have been treated with talk therapy alone. This is true of adolescents as well as adults, given that SSRIs were once thought to have fewer side effects when compared with older types of antidepressants (Antidepressant medications for children and adolescents: Information for parents and caregivers, 2013, NIMH). Since the development of SSRIs, the increase in psychotropic drug prescriptions has increased so rapidly that it is estimated that 1 in 5 of all Americans are on some form of psychotropic medication at any one time (Smith 2012:36). However, SSRI use in adolescents and young adults has become specifically linked to a rise in suicidal ideation. In addition to a spike in SSRI prescriptions for young people, there has been a corresponding increase in off-label prescriptions for antipsychotics for very young children with disorders such as bipolarity, conduct disorder, and ADHD. The increasing commonness of drugs prescribed to very young children for psychological conditions warrants that the FDA subject these drugs to additional regulations.

Unlike conditions that affect one's physical health, there is no blood test for depression or bipolar disorder. The intelligence and insight of the clinician alone determines whether a prescription is appropriate. Unfortunately, because of pressures by the insurance industry and general restrictions upon time and access to talk therapy, few people with possible mental health issues have the luxury of sustained, long-term therapy or even a provider who is a licensed psychiatrist. Often general practitioners are prescribing psychotropic drugs (Smith 2012:36). While this is a troubling development in general, it is particularly disturbing in light of the fact that the effects of psychotropic drugs can have such a lasting impact upon the life and health of the child -- for example, antipsychotics can cause weight gain and other associated complications such as diabetes and heart problems. And the most serious and lasting 'side effect,' of course, is death.

Despite the fact that SSRIs had been widely used to treat adolescent depression, it was not until 2004 that the FDA discovered that "4% of those [adolescents] taking SSRI medications experienced suicidal thinking or behavior, including actual suicide attempts -- twice the rate of those taking placebo, or sugar pills" (Antidepressant medications for children and adolescents: Information for parents and caregivers, 2013, NIMH). Although there are a wide number of SSRIs available, only the oldest SSRI, fluoxetine (more commonly known by the brand name of Prozac) is the only SSRI specifically approved for treating depression in minors: the others have not and thus all prescriptions of all other types of SSRIs for young people by physicians are classified as 'off-label use.' In fact, FDA specifically contraindicates one SSRI, paroxetine, for us in children and adolescents in the treatment of depression (Antidepressant medications for children and adolescents: Information for parents and caregivers, 2013, NIMH).

Off-label use is increasingly common not only for adolescents suffering from minor and major depressive disorders but also very young children. Until recently, it was believed that only adolescents and young people were likely to exhibit bipolar disorder and schizophrenia. However, with a corresponding rise in the development of new families of antipsychotics by drug companies, there has been a spike in prescribing these medications to very young children. With the development of Seroquel, Zyprexa and Abilify, the diagnosis of once-rare conditions increased exponentially: the diagnosis of bipolar disorder in children alone increased between the years 1994-2003 over 40-fold, from 20,000 to 800,000 nation-wide (Boodman 2012). And once again, primary care physicians are more likely to prescribe these drugs, given the lack of sustained, affordable, and intensive mental healthcare treatment.

One factor driving these diagnoses seems to be the increased medicalization of mental health conditions. Viewing psychological illnesses as conditions that can be 'cured' with a pill vs. long, sustained, expensive healthcare treatment is attractive. Yet a 2012 study in the Journal of Clinical Psychology found that SSRIs were no more effective than placebos, according to Barber (et al.). This is troubling, given the risks associated with SSRIs for young people. Evidence is mounting that social pressures rather than legitimate medical needs are behind these increases in prescriptions. Children as young as 18-months have been prescribed anti-psychotics for bipolar disorder and "antipsychotics…[are] the fastest-growing and most expensive class of drugs covered by the state of [Arkansas'] Medicaid program" were found to "typically prescribed to children to control disruptive behavior, which often stemmed from their impoverished, chaotic or dysfunctional families" (Boodman 2012). "Sedation is the key reason these meds get used" observed one pediatrician, enhancing the child's tractability, not addressing the underlying problem, and posing potentially dangerous health consequences (Boodman 2012). Once again, it is easier and more cost-efficient in the short run to prescribe medication that offer therapy, but the question of the drugs' efficacy in the long-term and the existence of a 'real' problem (versus a problem defined by the creators of the drug) remains unanswered.

Another troubling component of the spike in psychotropic drugs prescribed to minors is the fact that the reasons adolescents are more likely to experience suicidal ideation while on such medications is poorly-understood. SSRIs can increase agitation in some patients, and possibly give some depressed patients the 'energy' to act out that they lacked previously when mired in depression. Close monitoring is required, given the individual and idiosyncratic nature of the response of every patient to such drugs and this monitoring, in fact, is recommended strongly by the FDA. Once again, this underlines the importance of these drugs being prescribed by a person with experience in mental health issues, preferably with expertise in adolescent mental health (Antidepressant medications for children and adolescents: Information for parents and caregivers, 2013, NIMH).