One of the most basic rules of medicine is expressed in the Latin phrase primum no nocere – first do no harm. So here’s an real-life ethical dilemma for you; if antidepressants such as Prozac have the potential to cause harm to some patients, is it still okay for a physician to prescribe them if, in the balance, the drugs help more patients than they harm? That, apparently, is the dilemma now faced by the Food and Drug Administration (FDA).
Several years ago a careful analysis of trials of antidepressants reported that Prozac and the other drugs in its class (known as selective serotonin reuptake inhibitors, or SSRIs) increase the risk of spontaneously reported suicide-related events in children and adolescents. Accordingly, in 2003 the FDA issued a health-advisory that children and adolescents on Prozac might be at “increased risk of suicidal thinking and behavior”, and ordered that a black box warning be placed on all prescriptions. (The label is called a “black-box” warning because of its black border).
Physicians and parents took the warning seriously. From 2003 to 2005 the number of prescriptions for SSRIs for childhood and adolescent depression fell by 50%. This should have been a good thing, right? Perhaps not. New data shows that after 10 years of decline, the suicide rate in children and adolescents increased 18% in 2004, the most recent year for which there are data (Annual Summary of Vital Statistics: 2005. Pediatrics 119:345-360, 2007).
The data support the hypothesis that the risk of not prescribing Prozac for child and adolescent depression may, in fact, be more harmful than prescribing it. But we need to be careful to not over-interpret the data, for correlation does not prove causation. Now at least we know what the question is. Careful attention to study protocols will be needed to sort this one out, because suicidal thinking and behavior are difficult to classify at best.
