2006N-0414 Suicidality Data from Adult Antidepressant Trials
FDA Comment Number : EC30
Submitter : Dr. Julia Frank Date & Time: 12/01/2006 09:12:28
Organization : George Washington University MFA
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
As a practicing psychiatrist I urge the FDA not to slap an inappropriate black box warning against suicide risk onto antidepressants for adults. When the drugs are used appropriately, that is, with early initial follow up, even for the rare patient who gets agitated, the risk of actual suicidal behavior is negligible. The risk of suicide in untreated depression may be upwards of 10%. Rather than make people fearful of treatment, the appropriate safeguard is to ensure access to the appropriate level of treatment--to allow primary care physicians who prescribe these medications to charge for the visits, to see patients several times until they have improved, and to spend adequate time to educate their patients about all possible consequences of the drug use. Depression is pure suffering, a source of terrible burden to families, and a huge economic drain in our society. Making treatment less available is a huge step backward. A black box warning would have this effect and should be resisted.