New Evidence: Antidepressants unsafe for kids

By Edward Opton

Our regular readers know that we have concentrated on the significant safety risks of “antipsychotic” medications for children in foster care. Unfortunately, the antipsychotics are not the only problem. Consider the antidepressants.

The most commonly used antidepressants are the selective serotonin reuptake inhibitors (SSRIs), especially fluoxetine (Prozac), duloxetine (Cymbalata), paraoxetine (Paxil, Seroxat), sertraline (Zoloft), and venlafaxine (Effexor). Their tendency to produce suicidal and/or homicidal thoughts and actions has led the FDA to impose Black Box warnings on them. Even with the Black Box warnings, they continue to be big sellers.

A recent study[1] published in BMJ, formerly the British Medical Journal, suggests that the dangers of the major antidepressants are even greater than have been generally known. The researchers used not just published reports, but also data from double-blinded clinical studies reported by the drug manufacturers to the European Medicines Agency (EMA), to the British Medicines and Healthcare Products Regulatory Agency (MHRA), and summary reports made available by one of the manufacturers, Eli Lilly.

These clinical study data are more detailed, closer to the raw data, than the reports on which the U.S. Food and Drug Administration (FDA) relies.

The BMJ researchers inspected the reports for 73 double-blinded studies involving 18,526 patients and 64,381 pages of clinical reports. Looking at four unquestionably serious adverse effects (death, suicidality, aggressive behavior, and akathisia), the BMJ researchers found that suicidality was more than twice as common in children and adolescents treated with antidepressants as in those who received placebos. The results were similar for aggressive behavior and for akathisia: treatment with the drugs more than doubled the risk for children and adolescents.

Perhaps the most alarming findings are those concerning fraudulent practices. The companies that commissioned the research discarded some of the studies because of “fraudulent behavior,” “’concerns over the validity of the data,’” “’significant compliance violations,’” and in four data centers, “potential fraudulent behaviour.” The records from three data centers were “’impounded by the Swiss police for fraud.’”


[1] Sharma, T., Guski, L.S., Freund, N., & Gøtzsche, P.C., Suicidality and aggression during antidepressant treatment: systemaic review and meta-analyses based on clinical study reports. BMJ 1016;352:i65 (Published online 1/27.16).

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