EBD Blog

Concerns raised over the past 18 months about problematic side effects of selective serotonin reuptake inhibitors (SSRIs) in children appear to be affecting the frequency with which those drugs are prescribed, according to a story by Shankar Vedantam that appeared in the Washington Post (DC; US). Mr. Vedantam focused his story on the research standards used to determine whether the U.S. Food and Drug Administration approve drugs for clinical use.

Warnings that drugs such as Prozac, Paxil and Effexor can increase suicidal behavior in some children have resulted in a nearly 20 percent drop in U.S. pediatric prescriptions of the widely used antidepressants and have triggered deep concerns about the quality of current data on psychiatric drugs, doctors and regulators said.

The unprecedented fall of what were once considered wonder drugs comes as a series of taxpayer-funded analyses have systematically undermined the claims of industry-funded drug trials, raising thorny questions about the ways in which psychiatric drugs are being tested, marketed and used.

Mr. Vedantam obtained quotations from physicians and others who argue that the standard 12-week trials for approval of a drug are too brief. “‘The problem is we don’t have enough good data,’ said Thomas Laughren, director of the division of psychiatry products at the Food and Drug Administration. ‘All of our data are focused on the short term.’”

This is a sensible analysis, in my view. I infer from my admittedly scanty knowledge about the data available that the increased risk of suicide among children taking these drugs may be limited to a subset of all children for whom they are prescribed. Without carefully developed and long-term longitudinal study, we cannot know which children are in that higher-risk group. But, who wants to conduct the study where it is necessary to expose children to greater risk for suicide? Not I.

Using these drugs with our children requires that we exercise substantial care. Poeple serving children who have emotional and behavioral disorders should adhere to the dictim, “primum non nocere,” that is usually attributed to Hippocrates.

Links to coverage on the matter:

• Link to Mr. Vedantam’s story;
• 2004 Testimony by Robert Temple, MD, examining not only the research on suicidality but also on the effectiveness of these drugs;
• 2004 NIMH public information statement;
• Alliance for Human Research Protection story on prescription rates.