| 2006N-0414 | Suicidality Data from Adult Antidepressant Trials | ||||||||||||||||||||||
| FDA Comment Number : | EC43 | ||||||||||||||||||||||
| Submitter : | Dr. Bruce Taylor | Date & Time: | 12/01/2006 09:12:05 | ||||||||||||||||||||
| Organization : | Sheppard Pratt Health System | ||||||||||||||||||||||
| Category : | Health Professional | ||||||||||||||||||||||
| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| I am a Medical Director for Sheppard Pratt Health Systems and a former owner and Medical Director of Taylor Manor Hospital, the first hospital in the country to use chlorpromazine (Thorazine). I am a Distinguished Fellow of the American Psychiatric Association with over 25 years experience in clinical, administrative and research psychiatry. The opinions expressed below are my own.
Antidepressants save lives and are a vital part of our treatment arsenal against one of our nations leading causes of death - depression - often accompanied by suicidal ideation. I do not believe a black box warning will reduce suicides - it may do the reverse, by deterring many who need medication from being prescribed or taking it. I personally believe that most of the increased suicidality of antidepressant medication comes from its use in un-recognized bipolar patients, in whom it frequently causes a dysphoric mood cycling which is often misinterpreted as deepening depression; this often leads to additional antidepressant treatment instead of being seem as the emergence of rapid mood changes and bipolar illness which is best treated with a mood stabilizer. A rapidly changing mood state is very unpleasant, frequently leading to intense suicidal ideation and is often missed by trained professionals in all fields - including, unfortunately psychiatry. I say this because in my role as a medical director, admitting about 1,000 patients a year to our private psychiatric hospital, I have had to stop antidepressants in about as many suicidal patients as I have had to start them, usually because of unrecognized rapid mood cycling induced in patients previously not known to be bipolar and with no history of mania. Thus, I feel a regular warning about rapid mood cycling and careful screening for bipolar illness in the patient and the patient's family is warranted, but do not feel a black box warning will be the best way to handle this. I do not believe any single antidepressant is any worse in this regard, nor that it occurs with any greater frequency in a particular age group. I do not feel this issue has been adequately addressed in our research efforts, and I believe additional study is warranted. I further suggest that the FDA use its influence with the pharmaceutical companies to encourage or require that they increase both their general public and their mental health professional education programs to address this issue and enhance awareness of the risks of mood cycling and its proper treatment. Patients often only complain of increased depression if not questioned in detail about moodiness, mood swings, changes in mood and irritability. This self report issue makes it difficult for evaluators to note the problem unless they are specifically looking for it. A suggested appropriate, routine, non-black box warning on this issue might read as follows: "Antidepressant treatment has at times been known to be associated with increased suicidal ideation. Suicidal ideation is inherent to depression, and may occur as a patient is recovering and gaining energy before they are well. Increased suicidal ideation may also occur with increased moodiness or rapid mood cycling and may not be accompanied by mania or hypomania, despite the emergence of some bipolar symptoms. Suicidal patients should be carefully assessed before beginning treatment for any mood swings and for any family history of bipolar illness; before starting or continuing treatment with antidepressants, consideration should be given to whether a mood stabilizer is a better therapeutic | |||||||||||||||||||||||
| intervention. Suicidal patients are most often best treated in the controlled setting of a hospital until suicidal ideation has abated.
Thank you for the opportunity to comment. Bruce T. Taylor, M.D. Medical Director of Special Projects Sheppard Pratt at Ellicott City 4100 College Avenue Ellicott City, MD 21041-0396 410-465-3674 | |||