NO studies support polypharmacy for young people


A quality post from the HeroicAgencies listserve:
“Antidepressants have a black box for children, adolescents, and young adults, warning consumers and prescribers of increased risk of suicidality and clinical worsening, and the need for close monitoring (U. S. Food and Drug Administration, October, 15, 2004). The Hammad, Laughren, & Racoosin (2006) investigation revealed an average risk of suicidality for antidepressant takers double that of those on placebos in clinical trials . Moreover, only 3 out of 15 published and unpublished randomized controlled trials of SSRIs showed them to be more effective than placebo on primary outcome measures, and this is with all the design flaws that Barry and I have written about many times (yes, there is a chapter in Heart & Soul of Change, Revised Edition on this), including lack of adequate blinding, reliance on clinician-rated measures, short time frames, conflicts of interest, and minimization of risks. No patient rated measures ever showed a difference between the SSRI and placebo in any of the trials.

In the case of Zoloft (Sertraline), that drug is not approved for children or teens (except for OCD). There were two trials conducted by Wagner in 2003 of this drug. Individually, the results did not show a difference between Zoloft and placebo. When pooled, there was a difference in favor of Zoloft on the primary outcome measure. Interestingly, in these trials, participants could be discontinued at the discretion of the investigator for failing to improve, despite increased doses. This is curious, to my mind. Also, 17 Zoloft takers left the study due to adverse events compared with 5 in the placebo group. Of the 7 serious adverse events, there were 5 for suicidality and 1, aggression, in the Zoloft group compared with 2 for suicidality in the placebo group. True to form, the authors conclude that sertraline was well tolerated.

Seroquel is an antipsychotic, approved for mania or psychosis in this age group. This is a powerful and dangerous drug. Side effects include those typical for this class of drugs–somnolence, involuntary movement, cognitive impairment, elevated prolactin, intracardiac conduction, neuroleptic malignant syndrome, polycystic ovarian syndrome, weight gain and general metabolic disorders. Trazadone is an antidepressant and is not approved for under 18. Side effects include drowsiness, extrapyramidal symptoms, fatigue, liver problems, and more.

It is important to note that there are NO studies supporting polypharmacy for young people. This is all “throw the plate of spaghetti and see what sticks.” It is not hard to see that the pharmaceutical industry is very happy to have kids on as many drugs as possible–we’re talking double, triple, quadruple the profits. This trend is backed by recent studies. Psychiatric polypharmacy is both prevalent and increasing in pediatric populations, in tandem with more diagnoses. Although little is known about the safety and efficacy of regimens that involve concomitant use of two or more psychotropic drugs for children and adolescents, multiclass prescription for those under 18 is increasingly common.

So, this young person is playing with fire. I think that it is reasonable to share concerns with the adolescent, the parents/caretakers, and the psychiatrist and to make sure that the adolescent and family know about these risks and can make an informed decision about what they want to do. If she, and parents, want to decrease or eliminate medications, this could then be discussed with the psychiatrist who can reduce the meds to zero. Importantly, there are non-drug options, including psychotherapy, vocational support, sleep remediation, exercise, and others that can be beneficial, depending on the young person’s circumstances and preferences. ”

Jackie

Jacqueline Sparks, Ph.D.
Associate Professor
Department of Human Development and Family Studies
University of Rhode Island
2 Lower College Rd.
Kingston, RI 02881

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