FDA Reviews Adult Antidepressant-Suicide Link
Final Word May Not Come for a Year
July 1, 2005 -- The FDA has issued a public health advisory regarding data linking the possibility of an increased risk of suicidal behavior in adults taking antidepressants.
The FDA says it is reviewing recent scientific evidence showing a possible link. It is releasing this information now to update patients and health care providers with the latest information on this subject.
In October 2004, federal health officials ordered makers of antidepressants to use
alerting doctors and patients that the medications increase the risk of suicidal thoughts and behaviors in children and adolescents who take them.
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 changed.
- Adults whose symptoms worsen while being treated with antidepressants, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional.
These recommendations are consistent with warnings already present in approved labeling for antidepressants used by adults.