An often bitter dispute about the risks of antidepressant drug use peaked at an emotional 2004 FDA hearing. It may be coming to a tentative resolution with new recommendations for prescription labeling and further analysis of surveys and clinical trials.
In June 2005, the FDA asked manufacturers to provide information from clinical trials for a review of suicidal behavior and thinking in adults treated with antidepressants. The results were announced 18 months later, in December 2006. Two separate analyses of more than 400 clinical trials involving more than 100,000 adult patients came to similar conclusions. They found a slightly higher risk for suicidal thinking and behavior in patients taking antidepressants, compared to placebo, up to age 25. There was no difference at ages 25 to 30, and a slightly decreased risk for older patients, which decreased further after age 65.
On the release of this report, 15 national mental health advocacy and professional organizations issued an open letter emphasizing the risks of untreated depression and urging the FDA to consider carefully the influence of public statements about the risks and benefits of the drugs.
The report was followed by a public hearing at which, in contrast to the 2004 hearing, many speakers opposed further warnings or restrictions. In another split vote, in May 2007, the FDA’s advisory committee on psychopharmacological drugs recommended expanding the black box warning to include patients up to age 25. But it also recommended the addition of language that is unusual for a black box warning — references to the protective effect of antidepressants for older patients and to the suicide risk of untreated mental illness. The FDA is not required to accept the recommendations of its advisory committees but usually does.
A postscript appeared in the form of an April 2007 article in the Journal of the American Medical Association. The authors analyzed findings on more than 5,000 patients age 19 and younger who participated in 27 clinical trials, including several that were not part of the earlier FDA meta-analysis. Fifteen of the studies involved major depression, six involved obsessive-compulsive disorder, and six involved anxiety disorders.
Antidepressants were a little more effective than placebos in treating all three kinds of disorder. The difference was smallest for major depression and greatest for anxiety disorders. The authors estimated that compared to a placebo, an antidepressant would be helpful for 1 out of every 3 young patients treated for anxiety disorders, 1 of every 6 young patients treated for obsessive-compulsive disorder, and 1 of every 10 young patients treated for major depression. Most of the drugs showed an advantage only for adolescents; fluoxetine alone was found effective in children ages 12 and younger.
There were no suicides in any of the trials, but suicidal thinking and behavior were slightly more common in patients taking antidepressants — about 3%, compared to 2% for placebos. The difference was not statistically significant for any of the three disorders taken separately, but only when results from all trials were combined.
The debate will not end with this study or the new FDA recommendations. Placebo-controlled trials are the most reliable way to judge the risks and benefits of drugs, but they also have limitations. Clinical trials might overestimate the risks, because in the real world, the most common alternative to an antidepressant is no treatment at all, which is riskier than a sugar pill that is accompanied by hope-generating sympathetic attention. It is also possible that, instead of having more suicidal thoughts, patients who take antidepressants are simply more willing to admit such thoughts because the drugs make them less withdrawn and more communicative.
The field of mental health is rapidly evolving, and whether your interest is professional or personal, staying informed about these mental health issues is no easy job. The Harvard Mental Health Letter is a source of mental health news you can trust…and it comes directly from the more than 8,000 doctors and researchers at Harvard Medical School.
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Comments: 8
Also, the "magic" pill isn't always the one that's going to work for you or agree with you physically. It's trial and error and a suicidal person must be watched closely at the beginning of their treatment. I had a co-worker start taking Zoloft and it made her shake like the room temperature was 40 below! I told her to go back to the doctor and try something else. Prozac always gets a bad rap, too. It worked wonderfully for me for quite a while.
I'm constantly touting the wonders of therapy and how it saved my life. So much so that I'm sure the people around me are sick do death of me! ;)
In these large studies that look at antidepressants and suicide risk, many of the patients did receive psychotherapy though psychotherapy was not what the researchers were focusing on. That's not because they don't believe that psychotherapy is helpful — I'll bet they do. Rather — you can only study one thing at a time! Otherwise it gets too hard to sort things out.
Since suicide is (thankfully) a rare event, researchers have to look at very large numbers of individuals in order to see whether the risk of suicide has gone up or gone down. This question is very important to answer, so that people who are considering antidepressant treatment can weigh the risks for themselves.
But, as you point out, medication is not the only choice for treating depression—and it's not always the best choice. Psychotherapy is always an important treatment option to consider.
It's great, Jill, that it is not a great idea to refer to medications as "magic" pills. There is nothing magic about them.
Yes, I have met many people who have a very rapid and dramatic positive response to an antidepressant. When that happens, it's wonderful and can be life-changing. But that is not the usual experience. The experiences you describe are just as common.
You both got it just right: Trial and error plus watching is a key part of the process of treatment.
And — to Andrea T's point — it's easier to manage the trials and the errors if you have a good relationship with a therapist and/or psychiatrist. The two (or three) of you go through it and watch it together.
Persistence is much more effective than magic!
To be honest I have found more help with proactive theorpy than any drugs, which when on my own, I most of the time will not take anyhow. Right now, I am not doing any theropy and not taking any of the proscribed drugs, and handling things very well. Hopefully I can keep this up, I just keep living each day one day at a time.
I have learned to think that the drugs used really don't do much for you, as much as they make Doctors think they do.
This could be one reason people commit suicide while on a certain medications.