FDA's antidepressant warning linked to increased suicide rate

The addition of black box warnings about increased suicide risk to antidepressants was associated with reduced mental health treatment and increased suicide attempts and deaths among young people, new analysis suggests.

Investigators said the combined evidence supports “the possibility of re-evaluating and replacing” the U.S. Food and Drug Administration's (FDA) black box warnings with routine warnings on product labels.

“The sudden, simultaneous and widespread effects of these warnings – reduced treatment for depression and increased suicides – are documented by 14 years of powerful research. Observed harms and observed increases after black box warnings The consistency of the lack of benefit indicates that this is “no coincidence,'' said lead author Stephen Smelai, professor of population medicine at Harvard Medical School and the Harvard Pilgrim Healthcare Institute in Boston. said in a news release.

The research is Published online October 7th health problems.

How did we get here?

In October 2003, the FDA warned that antidepressants may be associated with suicide in people under the age of 18 shortly after starting treatment. In January 2005, the FDA required permanent black box warnings about this risk on product labels, television, and print advertising for all antidepressants.

In May 2007, the FDA expanded the 2005 Black Box Warning to include young adults up to age 24, and this broad warning remains in effect today.

Soumerai and colleagues said they evaluated the intended and unintended consequences of antidepressant warnings for youth through a systematic review of “the most reliable evidence in the field.”

Through a thorough literature search, researchers identified the following 34 studies: depression and suicide-Related results were published in a peer-reviewed journal after the warning was issued.

Eleven of these studies measured sudden changes in outcome trends after the warning and were included in the analysis. These outcomes include monitoring for suicidality, seeing a doctor for depression, diagnosing depression, seeing psychotherapy, antidepressant treatment and use, psychotropic drug addiction (a surrogate for suicide attempts), and suicide. Includes death.

more harm than good

Four studies of more than 12 million patients found consistent evidence of “sudden and significant” long-term declines in doctor visits for depression and depression diagnoses after the FDA warning. The research team pointed out that it was found.

These studies found that physician visits for depression and depression diagnoses increased in the years before the warning, and that post-warning visits and diagnoses suddenly and persistently decreased by anywhere from 20% to 45%. It was shown that it did. “Some spillover occurred in a comparison group of adults who were not covered by the FDA warning,” the researchers said.

Seven studies found evidence that antidepressant treatment and use suddenly decreased by anywhere from 20% to 50% after the FDA warning. Most of these studies show that antidepressant use increased in the years before the FDA warning, followed by a steep and sustained decline in usage.

Three studies found evidence of declining or stable trends in psychotropic drug addiction and suicide deaths in pediatric patients before the alert was issued, and that these trends increased sharply after the alert was issued.

The purpose of the warning was to increase monitoring by doctors for suicidal tendencies in patients treated with antidepressants, but the data suggests that did not occur.

After the warning was issued, less than 5% of pediatric patients were monitored according to the FDA-recommended exposure schedule. This low rate has not changed from the rate before the warning was issued.

No studies have documented improvements in mental health care or reductions in suicide attempts or suicides after the warning went into effect.

“Overwhelming evidence suggests that continued use of these warnings may do more harm than good,” the authors write.

About data

The findings are “extremely concerning and provide reason to pause, reconsider, and possibly recalibrate boxed warning recommendations related to antidepressants in youth,” the Toronto, Canada, news agency said. said Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto. The head of the Department of Mood Disorders Psychopharmacology said: Medscape Medical News.

“Unfortunately,” said McIntyre, who was not involved in the study, this data shows that the boxed warning “has the unintended consequence of increasing the likelihood that people will not receive appropriate medical care for mental disorders.” “We have provided evidence to suggest that this has resulted in negative outcomes.” Including suicidal tendencies. ”

He added: “Twenty years later, new information is now available that not only recalibrates initial risk assessments, but also improves access to health care for people living with mental illness in their youth.'' “It provides an opportunity to reduce the externalities of attrition,” he added. ”

An FDA spokesperson said: Medscape Medical News “In general, FDA does not comment on specific studies, but we evaluate them as part of the body of evidence that improves our understanding of specific issues and supports our mission to protect public health.”

This study received no commercial funding. Author disclosures are listed with the original article. McIntyre has received speaking and consulting fees from Lundbeck, Janssen, Alkermes, Pneumo Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, and Neurocrine.