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by: Stephen Soumerai Harvard University via The Conversation

(THE CONVERSATION) #Depression in young people is vastly undertreated. About two-thirds of depressed #youth don’t receive any #mentalhealthcare at all. Of those who do, a significant proportion rely on #antidepressant medications.

Since 2003, however, the U.S. #FoodandDrugAdministration has warned that young people might experience suicidal thinking and #behavior during the first months of treatment with #antidepressants.

The #FDA issued this warning to urge clinicians to monitor #suicidalthoughts at the start of treatment. These warnings appear everywhere: on TV and the internet, in print ads and news stories. The most strongly worded warnings appear in black boxes on medication containers themselves. #FDA warns against using some infant formulas after hospitalizations, death

We are professors and researchers at Harvard Medical School, the University of Pennsylvania Perelman School of Medicine and University at Buffalo. For over 30 years, we have been studying the intended and unintended effects of health policies on #patient safety.

We have found that #FDA drug warnings can sometimes prevent life-threatening adverse effects, but that unintended consequences of these warnings are also common. In 2013, working for the #FDA itself, we published a systematic review of the effects of previous #FDA warnings on a variety of medications. We found that about a third backfired, resulting in underuse of needed care and other adverse effects.

In our more recent study from 2020, we found that the #FDA #antidepressant warnings have led to reduced #mentalhealthcare and increased #suicides among #youth – even though researchers have yet to find a clear link between #antidepressants and increased suicidality in young people.

Further, despite the warnings, monitoring by clinicians of suicidal thoughts at the start of treatment has not increased from its tiny rate of less than 5%.

#JamesDonaldson notes:

Welcome to the “next chapter” of my life… being a voice and an advocate for #mentalhealthawarenessandsuicideprevention, especially pertaining to our younger generation of students and student-athletes.

Getting men to speak up and reach out for help and assistance is one of my passions. Us men need to not suffer in silence or drown our sorrows in alcohol, hang out at bars and strip joints, or get involved with drug use.

Having gone through a recent bout of #depression and #suicidalthoughts myself, I realize now, that I can make a huge difference in the lives of so many by sharing my story, and by sharing various resources I come across as I work in this space.  #http://bit.ly/JamesMentalHealthArticle

#Youth #suicides rose following #FDA warnings

For our 2020 study, we obtained 28 years of data, between 1990 and 2017, on actual #suicide deaths in the U.S. among #adolescents and young #adults. We used data from the WONDER Database, maintained by the U.S. #CentersforDiseaseControlandPrevention, which contains mortality counts based on death certificates for U.S. residents and population counts for all U.S. counties.

We found that during the pre-warning period, there was a 13-year stable downward trend in #youth #suicides, following availability of new and safer #antidepressants.

That trend reversed, we found, soon after the #FDA began #antidepressant warnings in late 2003. #Youth #suicide deaths increased significantly.

Then we applied our findings to the whole U.S. population of #adolescents and young #adults. The results of that analysis suggest that there were almost 6,000 additional #suicide deaths in just the first six years after the #FDA issued the boxed warnings, from 2005 through 2010. The rates also continued to rise thereafter.

Over this same time period, older #adults – whose #depression is not targeted by the warnings – experienced much lower increases in #suicide.

Fewer depressed #youths got treatment

Our findings align with a growing body of research that confirms these warnings have had serious unintended effects: scaring many #patients, as well as their #parents and #doctors, away from both #antidepressant medications and psychotherapy that can reduce major symptoms of #depression.

These studies include a rigorous 2017 study that analyzed #mentalhealthcare trends among 11 million youths who rely on Medicaid for insurance coverage. This research documented that immediately after the #FDA warnings began in 2003, there was a sudden and sustained 30%-40% drop in #youth visits to #doctors for all #depression care, including #antidepressant prescriptions.

Seven years after the first #FDA warning, #doctor visits for #depression by young people had dropped by around 50%, compared with the pre-warning trend, thus severely reducing treatment and #suicideprevention.

That trend included #Black and #Latino youths, who have already long suffered from undertreatment.

Almost simultaneously, #youth poisonings via prescription drugs, such as sleeping pills, went up. Research has shown that prescribed #medications are a widespread method by which young people attempt #suicide. This finding adds to the evidence that the #antidepressant warnings increased suicidal #behavior.

In 2018, researchers reported on two #patients in their 20s whose experiences illustrate the potential real-life impacts of the black-box warnings. Both young #adults had been prescribed #antidepressants for major #depression and severe panic attacks, but they refused to take them because of the #FDA’s message.

Their conditions worsened, and eventually both attempted #suicide. Fortunately, family members were able to intervene in time, and each young #adult was then hospitalized.

After they accepted the reassurances of #hospital #psychiatrists that the benefits of the medications would likely exceed any risks, both #patients began to take their prescribed #antidepressants. These medications, combined with talk therapy, alleviated their symptoms without intensifying #suicidalthoughts.

Reevaluating the warnings

As #scientists, we are trained to always seek potential alternative explanations – some additional factor not included in the research – that could explain the reduction in care or increase in #suicides that we and others have recorded in our studies.

However, the sudden, simultaneous and large effects – all of which directly reduced treatment and increased suicidal behavior – strongly suggest this is not a coincidence. It is unlikely that any outside factor can account for the multiple parallel effects on #depression care, suicidal #behavior and #suicide deaths.

A large and growing body of evidence shows that the FDA’s black-box warnings on #antidepressants need to be reevaluated.

More generally, there’s a need for independent researchers to monitor the effects of #FDA warnings on public health – both intended and unintended.

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https://standingabovethecrowd.com/2022/03/jamesdonaldson-on-mentalhealth-after-the-fda-issued-warnings-about-antidepressants-youth-suicides-rose-and-mentalhealthcare-dropped/