2002D-0371 - Format and Content of Clinical Pharmacology Section of Human Prescription Drug Labeling
FDA Comment Number : EC5
Submitter : Dr. Steven Methner Date & Time: 03/30/2004 05:03:12
Organization : University of Utah Neuropsychiatric Institute
Health Professional
Category :
Issue Areas/Comments
I am a clinical Psychiatrist practicing psychiatry for 30 years. I am particularly concerned about the way the FDA is managing the controversy over the issue of suicide and antidepressants. These medications are life saving and there are not placebo controlled studies I am aware of to warrant a precaution in prescribing. It appears to me the decision to handle it this way is based on emotional reaction to a few unique cases in an election year and to shift responsibility to the drug company's rather than do the studies. This is premature to make a package insert warning. The way this has been handled is frightening my mentally ill patients and I am receiving reports of patients who have stopped their antidepressant medication. This has put them at risk for relapse and suicidal behavior. I believe your intentions are in the right place but the way you have implemented this has been reactionary to a few cases and have frightened patients. If I were you I would look to see if your behavior results in a spike of suicide attempts and deaths in the next few months due to mentally ill people going off their medication.
Also, it may be true the antidepressants on a whole do not separate out from placebo with children but that is not true for adults. It is important to emphasize that these are still effective medications for adult depression. Suicidal rates have been positively lowered by the use of antidepressants in adults. This is a complex issue, I would have preferred a letter to physicians of your concern and gathering opinions and data before posting a warning in package inserts. Now mentally ill patients, who by definition don't always think rationally or have good judgement in decision making, may not seek treatment due to the fear factor engendered by this approach. I thought this was laid to rest 10 years ago in the Prozac studies that showed no increased risk of suicide. Now this is being revisted in a more reactionary and fear inducing way.
Next time please be more respectful of the mentally ill and the fact still exists that most do not seek help or treatment and this has made it more difficult.
Steven Methner,M.D.