Antidepressant Study Roils FDA, Media

June 20th, 2014 by MorganDowney Leave a reply »

A new study on the use of antidepressants and suicides is roiling the Food and Drug Administration and the media. The study by Lu et al and published in the BMJ this week investigated whether widely publicized warnings in 2003-4 from the FDA about possible increased risk of suicide risks with antidepressant use in children and adolescents were associated with changes in antidepressant use, suicide attempts and completed suicides among young people. Researchers studied 1.1 million adolescents, 1.4 million young adults and 5 million adults.

Researchers found that the background studies behind the FDA warnings showed mixed outcomes. Nevertheless, after the FDA warnings, trends in antidepressant use and poisonings changed abruptly after the warnings. The FDA warnings received widespread and repeated media coverage becoming “frightening alarms to clinicians, parents, and young people.”

The decline was greatest among young adults, less among young adults and adults. Simultaneously, there were significant increases in psychotropic drug poisonings in adolescents and young adults but not among adults. Completed suicides did not change for any group. The study also found that there was no increase in alternative therapy usage

The researchers concluded that, “Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting.”

The media reaction to this study has been to shout that the warnings backfired and led to more suicide attempts. Meanwhile, the FDA is saying it sees no reason to change the warnings.

Why bring this study up in an obesity report? Several reasons.

First, obesity and depression co-occur in many people. There is so much overlap that most clinical trials of obesity interventions routinely exclude persons with depression from the study population. One reason is adherence. But another significant reason is that many antidepressants cause weight gain. In a recent study in JAMA Psychiatry found that people taking citalopram (Celexa) gained more than 2.5 pounds a year, on average. Those taking fluoxetine (Prozac) gained 1.5 pounds and those on sertraline (Zoloft) gained nearly 2 pounds in the course of a year. On the other hand, those taking bupropion (Wellbutrin) lost an average of nearly .5 pounds a year. (Bupropion is one component of the drug, Contrave, together with naltrexone, currently under consideration by the FDA for the treatment of obesity.) The discontinued drug, Meridia, was originally developed for the treatment of depression when its potential for weight loss was identified.

The main FDA warnings came out in 2003-2004.However in May, 2007, the FDA expanded the warnings to include young adults. The next month a FDA advisory panel recommended against approval of the drug rimonabant for the treatment of obesity, in part because of concerns of increase suicidial ideations. (See Stephanie Saul’s article in the New York Times.) Approval of rimonabant was reversed in 2008by the European Medicines Agency after the FDA’s negative decision.

Second, it seems evident now that the evidence base for the FDA warns was at best mixed. But the media so amplified the warnings that the crescendo did not admit of any doubt or consideration that maybe adolescents and young adults actually needed these medications and did not have any good alternatives. Unintended consequences are real but our current system, for all its reliance on scientific analysis, provides little room for doubt and discussion. The media like clean, crisp ‘talking points’ that fit their pre-defined “frames”, e.g. pharmaceutical companies are bad, natural remedies are good, etc. Changing the media’s approach is very difficult; there are just too many outlets. The FDA, on the other hand, is a single organization that can incorporate this experience into future activities.


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