Remember several years ago, when the FDA issued warnings about the risk of suicide for children and adolescents who were taking antidepressants? Well, stand by for an attitude adjustment. A study published last month in BMJ showed that the effort to save children probably harmed them instead.
The researchers tracked an increase in suicide attempts that seem to have been the result of depressed youngsters failing to seek treatment at all. They said the study shows how public health warnings that were intended to do good sometimes can backfire, especially if the subject is sensitive and gets a lot of media attention.
As the Washington Post recalled, the FDA issued warnings in 2003 and 2004 of an increase in suicidal thoughts among some children and adolescents who were taking a certain class of antidepressants (selective serotonin reuptake inhibitors, or SSRIs); you might recognize some of their brand names — Paxil and Zoloft.
So dire was the potential for harm that the FDA required manufacturers of the drugs to include a “black box” warning on the label. Such warnings denote the highest level of concern about side effects, including death. The warnings specified that the drugs presented an increased risk of suicidal thoughts and behaviors in youths who take them.
The media were all over this story, and the study’s researchers said the coverage focused more on the tiny percentage of patients with those thoughts than on the vastly larger number of youths who benefited from antidepressants.
After the warning, antidepressant prescriptions declined sharply among kids 10 to 17 years old, and among young adults from 18 to 29. Coincidentally, the researchers found, the number of suicide attempts rose by more than 1 in 5 among the younger group, and by more than 1 in 3 among the older group.
Of course the media’s lapel-grabbing headlines — “FDA links drugs to being suicidal” (New York Times), and “FDA confirms antidepressants raise children’s suicide risk” (The Washington Post) — “became frightening alarms to clinicians, parents and young people,” the researchers wrote. But consumers bore some responsibility as well.
“There was a sort of overreaction by the media, but also an excessive caution on the part of patients,” Christine Lu, a Harvard Medical School researcher and co-author of the BMJ study, told The Post. “Lots of people who needed treatment steered clear because of the fear factor. … For any drug, there are risks, for sure. But there’s also the risk of leaving the underlying condition untreated.”
Her team plotted the rise in suicide attempts by studying reports of nonfatal poisonings involving psychiatric medicines, which is a common indicator of attempted suicides. They thought the likely number of suicide attempts probably was much higher, because they didn’t track other suicide methods and poisonings that went unreported.
As The Post noted, the BMJ findings dovetail with a 2007 study in the American Journal of Psychiatry that showed a steep decline in antidepressant prescriptions after the feds issued the warnings.
That study didn’t prove that suicides rose as a direct result of fewer such prescriptions, but experts said there weren’t a lot of other explanations.
Despite their conclusion, the BMJ researchers don’t believe that the FDA was wrong in issuing the warning 10 years ago. But “FDA advisories and boxed warnings can be crude and inadequate ways to communicate new and sometimes frightening scientific information to the public,” they wrote.
And the researchers point out that media attention can raise awareness of medical situations people should know about, like the risk of Reye’s syndrome in children who are given aspirin. But, they said, sometimes “the information may be oversimplified and distorted when communicated in the media.”
Not every scientific mind agreed that advisories were too bold. In Discover magazine, an article by The Neuroskeptic titled “The FDA’s Antidepressant Warning Didn’t Really ‘Backfire,” took issue with the study’s conclusions:
“And while the authors never outright state that the FDA’s warning caused the extra suicide attempts,” it said, “they strongly imply that, using phrases such as ‘It is disturbing that after the health advisories, warnings, and media reports [...] we found substantial reductions in antidepressant treatment and simultaneous, small but meaningful increases in suicide attempts.’ “Are they right to be disturbed? By my reading – no. Their data just don’t support a causal effect.”Neuroskeptic’s argument is interesting and rather geeky, and deserves consideration. The lesson here is that both regulators and the people who watch them must not be alarmists when communicating drug risks. And the lesson for parents with children who are depressed is to discuss frankly and fully the risks and benefits of all treatments. Like all drugs, antidepressants might be exactly what some people need, and not the best option for others.
It’s a matter of the degree of illness and managing its risk.