FDA antidepressant warnings of suicide risk among kids may have the opposite effect

  • #1
berkeman
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Oh my, this is a surprising (to me) study result, although after reading through it I guess it could make sense.

[ First, if you know somebody who may be considering suicide, please help them use the resources available to them via crisis hotlines. In the USA, there is the phone number shortcut 988 and the longer number 800-273-8255. For international folks, please see the Wikipedia article: https://en.wikipedia.org/wiki/List_of_suicide_crisis_lines ]

It looks like the warning labels placed on anti-depressant drug packaging have actually discouraged their use by minors and young adults, and that has led to higher rates of problems and even suicides. The study authors are now recommending some ways to mitigate this problem...

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CNN
The US Food and Drug Administration has warned that antidepressants may be linked with suicidal thoughts and behaviors among youth since 2003, leading to a black box warning for minors in 2005 and an expansion to young adults in 2007.

The black box, or boxed, warning refers to a prominent warning encased in a bold black border in the labeling or pamphlet of some medications. It’s meant to raise awareness of certain risks of taking the drug and to increase physician monitoring of suicidality.

But new research has found boxed warnings on antidepressants may have had unintended negative consequences for pediatric health care and suicidality — including reductions in mental health care and increases in psychotropic drug poisonings and suicide deaths, according to the systematic review published Monday in the journal Health Affairs. (Psychotropic drugs or other substances influence how the brain functions and cause changes in mood, awareness, thoughts, feelings or behavior.)

<<snip>>

Some found the surveillance of suicidality lacking. Following the FDA advisory and warning, doctors monitored fewer than 5% of pediatric patients in accordance with the FDA’s recommendations for scheduled contact with patients — a rate similar to that of the pre-warning period, the authors found. None of the studies noted improvements in mental health care or declines in suicide attempts or deaths after the warnings were implemented.

To the contrary, four studies totaling more than 12 million patients found significant declines in doctor visits for depression symptoms or diagnoses. While an increase in antidepressant use occurred before the FDA advisory, there were abrupt and sustained declines in use — ranging from 20% to 50% — after the warnings.

Three studies reported increases in psychotropic drug poisonings, which suggest suicide attempts, and in suicide deaths among children. The effects of the warnings also spilled over to young adults ages 18 to 24.

Note that there is some dissent about this finding:

It’s important to note that increases in suicide rates could be due to factors other than the boxed warnings, Fortuna said, as “we are amid a mental health crisis in the United States, and there has been a lot of research on increasing mental illness and suicidality over the last decade and heightening during the pandemic.”

<<snip>>

Additionally, the findings on abrupt decreases in antidepressant use are technically based on declines in the dispensing of antidepressants, said Dr. Kao-Ping Chua, associate professor of pediatrics at the Susan B. Meister Child Health Evaluation and Research Center at the University of Michigan Medical School. Chua wasn’t involved in the research.

“We do not know whether these effects have persisted,” he added. “There is reason to suspect they have not. For example, our previous study showed that there was a sharp rise in antidepressant dispensing to female adolescents and young adults during the COVID-19 pandemic — a rise that occurred despite the FDA black box warning being in place.”

But it’s unclear “whether this represents inappropriate withholding of antidepressants to young people with severe depression versus a cessation of antidepressant therapy in young people who never or no longer needed to be on these medications,” Chua added via email.

Another limitation is that the review focused on the short- to medium-term effects of a warning issued 20 years ago, Chua said.

CNN Article: https://www.cnn.com/2024/10/07/heal...depressants-suicide-youth-wellness/index.html
 
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The association between starting antidepressants and suicidality has been suggested for decades and has been linked to the increase in motivation and activity as a treatment effect that starts before any noticeable improvement in mood. However, generally the evidence has always been and continues to be weak. This weak association along with the lack of evidence for effectiveness in young people, does seem to justify the caution and the preference for psychological therapy as the first line treatment.

In recent years it has been suggested that the main risks are associated with the newer SSPI antidepressant drugs though previous studies have failed to identify difference with the available antidepressants, thankfully, suicide as an outcome is a very low frequency behaviour which complicates collecting high quality data. Any risk, if one is present, appears to occur early in treatment and while the labelling warnings were introduced in a number of countries the rate of self harm and suicide continues to vary considerably by location. I suspect that parents having to bear the cost of more expensive psychological interventions in the USA is an important factor in this, though access to specialist services for Children and Adolescents can be difficult anywhere.

https://www.aacap.org/aacap/medical...k_of_Suicide_in_Children_and_Adolescents.aspx
 
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