Even before the publication of these recent reports, the FDA says it had already begun the process of reviewing available data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants.
The agency has asked manufacturers of these drugs to provide information from their studies in much the same way they approached evaluation of the risk of suicidal behavior in children taking antidepressants.
The review will involve hundreds of studies and may take more than a year to complete, it says.
In the meantime, the FDA is advising doctors and patients to be aware of the following:
- Adults being treated with
antidepressant medicines, particularly those being treated for depression,
should be watched closely for worsening of depression and for increased
suicidal thinking or behavior.
- Close observation of adults may
be especially important when antidepressant medications are started for
the first time or when doses for the specific drugs prescribed have been
- Adults whose symptoms worsen
while being treated with antidepressants, including an increase in
suicidal thinking or behavior, should be evaluated by their health care
These recommendations are consistent with warnings already present in approved labeling for antidepressants used by adults.
SOURCE: FDA. WebMD Medical News