By Madeleine Levin, MPH
The FDA issued a Public Health Advisory on June 30, 2005 warning that adults taking antidepressant medications should be closely monitored for increased suicidal behavior. The agency had issued a similar warning about children and antidepressant use last fall.
The FDA has not concluded whether or not anti-depressants increase the likelihood that adults will try to kill themselves, but instead is focusing on the need to monitor adults to try to make sure that doesn't happen. They are especially concerned about the risk when adults first start taking the anti-depressants, or increase the dosage.
The FDA is currently reviewing all available data, and expect that their review will take a year or longer to complete. A similar review of available data on children and antidepressants determined that there was a significant increase in suicidal thinking and behavior, which prompted the FDA to require antidepressant drug manufacturers to add a black box to the label warning about the increased risk for children. Placing a black box around a warning, similar to those for cigarettes, are the strongest type of warnings about risks that the FDA requires, and indicates FDA's great concern.
The FDA explained that its latest advisory warning was prompted by several studies suggesting possible increased risks of suicidal behavior in adults being treated with antidepressant medications. They did not specify all the studies that concerned them, but mentioned a clinical trial for the use of the antidepressant drug Cymbalta to treat urinary incontinence in women. Women taking Cymbalta were more likely to attempt suicide than women in the general population. This study is particularly worrisome because the drug was being tested for a use that has nothing to do with depression or mental illness - and therefore the women in the study should have been unlikely to commit suicide. In contrast, when depressed people taking anti-depressants are studied, it is impossible to know if they attempted suicide because they were already depressed, or because the drug made them more suicidal than they otherwise would have been.
In February of 2005, the British Medical Journal published three studies about suicidal behavior and antidepressants in moderately to severely depressed adults. One study found an increased risk of suicide attempts among those being treated with antidepressants compared those being treated with a placebo, while the other two found no increase in the risk of suicide among those treated with antidepressants. None of the studies found an increase in deaths from suicide among patients using antidepressants. Although the studies came to conflicting conclusions, the authors agreed that increased suicidal behavior caused by antidepressant use cannot be ruled out. An accompanying editorial urged clinicians to closely monitor patients during the early stages of antidepressant use, when most incidents of increased suicidality have been observed.
Anti-depressants have been widely prescribed for a range of problems, and these warnings mean that physicians and patients need to be more cautious. Increased monitoring is important, but it puts stress on family members who may already be very concerned about their loved ones. The FDA needs to move quickly to examine the existing data to determine whether anti-depressants increase the risk of suicidal thoughts, attempts, and deaths among adults, compared to other treatments. Further research and closer monitoring by the FDA will hopefully continue to clarify the relationship between antidepressant use and suicidal thoughts and behaviors.
For more information go to
http://www.fda.gov/cder/drug/advisory/SSRI200507.htm