by Stephen Soumerai, and Ross Koppel: For Complete Post, Click Here…
Agency refuses to budge despite evidence it’s doing more harm than good.
(T)he FDA has long refused to remove one important barrier to effective care: a dangerous, outdated warning they require on newer, safer antidepressants. We hope a new study — the largest ever conducted on the consequences of this warning — changes that. (One of us, Soumerai, is a co-author of the study.)
The study, published last month in the American Psychiatric Association’s journal Psychiatric Research & Clinical Practice, examined 28 years of all U.S. death certificate data; it found that these harsh FDA warnings increased rather than decreased suicides over the last decade. These dire boxed or “black box” warnings, and their claim that antidepressants can lead to suicidal thinking in young people, scared them (and their parents) away from needed depression treatment.
Starting in 2007, studies showed the chilling effects of these warnings led to steep reductions in identification of depression, care-seeking, drug treatment, and even to reduced monitoring of suicidal thinking in treated youth. Ironically, the goal of the warnings was to increase monitoring for suicidal ideation, not reduce it. Even worse, the abrupt declines in treating youth with depression likely increased suicide attempts.
Though the FDA has dismissed these effects, a few graphs from the most recent study and previous research make their severity tragically obvious.
As a graph from the new study clearly illustrates, the warnings immediately halted an upward trend in teen antidepressant use; the abrupt 31% reduction in teen antidepressant use persisted until at least the end of the study, or about 7 years.
More alarming, the same graph also shows that after the warnings were required, there was an almost immediate and dramatic increase in psychotropic drug poisonings — often indicating suicide attempts.
This study confirms and amplifies previous findings by focusing on actual suicide deaths in the U.S. over 28 years.