Editor’s note: If you or someone you know is struggling with suicidal thoughts or mental health issues, dial 988 to connect with a trained counselor by calling the 988 Suicide and Crisis Lifeline. 988 Lifeline website.
CNN
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The U.S. Food and Drug Administration has warned since 2003 that antidepressants may be linked to suicidal thoughts and behavior in young people, and issued a black box warning for minors in 2005. In 2007, the program was expanded to include young people.
A black box, or boxed warning, is Contains a prominent warning On some drug labels or brochures, it is surrounded by a bold black border. This aims to raise awareness about the specific risks of drug intake and to increase monitoring of suicidality by doctors.
But a new study finds that boxed warnings about antidepressants may have had an unintended negative impact on pediatric health care and suicide rates. These include a decline in mental health care, an increase in psychotropic drug addiction and suicide deaths. systematic review Published in Monday’s Health Affairs magazine. (Influence of psychotropic drugs and other substances) how the brain works It causes changes in mood, consciousness, thoughts, emotions, and behavior. )
“Our goal was to assess the intended and unintended consequences of antidepressant warnings for young people by systematically reviewing the most reliable evidence in the field,” said the study’s lead author. said Dr. Stephen Sumelai, professor of population medicine at Harvard University Pilgrim Healthcare. Massachusetts Institute and Harvard Medical School news release. “We screened all available research reports on the warning and focused on those that met rigorous study design criteria and synthesized the most reliable data available.”
The 11 reports on which the findings were based included previous studies that measured immediate changes in outcome trends after the 2003 FDA recommendation or the 2005 boxed warning.
Some felt there was a lack of monitoring for suicidality. After FDA recommendations and warnings, the authors found that less than 5% of pediatric patients were monitored by physicians following FDA recommendations for planned patient contact, a rate similar to the pre-warning period. did. None of the studies found that mental health care improved or that suicide attempts or deaths decreased after the warnings were implemented.
On the contrary, four studies involving a total of more than 12 million patients found a significant reduction in doctor visits due to symptoms and diagnoses of depression. Antidepressant use increased before the FDA recommendation, but after the warning there was a sudden and sustained decline in use, ranging from 20% to 50%.
Three studies reported an increase in psychotropic drug intoxication suggestive of suicide attempts and suicide deaths among children. The warning also affected young people aged 18 to 24.
“The sudden, simultaneous, and far-reaching effects of these warnings – a decline in depression treatment and an increase in suicides – has been documented by 14 years of powerful research,” Sumelai said. “The consistency of the observed harms and lack of observed benefits after black box warnings indicate that this is no coincidence.
“We recommend that FDA consider incorporating black box warnings into its routine warning list to reduce health risks, or in some cases removing the warnings altogether.”
In response to a request for comment, an FDA spokesperson said in an email that the agency generally does not comment on specific studies.
“Evaluating product safety is an ongoing and ongoing process, and we regularly consider new data, including published literature, as part of our post-marketing surveillance. Pharmacovigilance” added the spokesperson.
Dr. Lisa R. Fortuna, president of the American Psychiatric Association’s Council on Children, Adolescents and Their Families, said in an email that the study does not show that antidepressants or boxed warnings directly cause suicidality. Ta. Fortuna was not involved in the study.
Understand the findings
In the United States, depression main causes of suicideand suicide is 2nd cause of death According to the National Institute of Mental Health, it is the leading cause of death among 10- to 14-year-olds and the third leading cause of death among 15- to 24-year-olds.
Since the Boxed Warning went into effect, best practices in psychiatry have been to treat moderate to severe depression in adolescents and follow up antidepressants within two weeks of starting use, even after increasing the dose. said Fortuna, professor and chair of the psychiatry department. Neuroscience at the University of California, Riverside. Families should be informed of the warnings and counseled about the relative risks of untreated depression versus the risks of antidepressants.
However, “this study convincingly suggests that black box warnings may have made at least some health care providers and families nervous about antidepressant treatment for adolescents,” Fortuna said. he said. “The FDA warning was intended to increase physician oversight for suicidal thoughts and behavior, so it was surprising that this did not appear to be the case.”
The lack of monitoring may also be related to clinical overreach, Fortuna said. Many adolescent psychiatrists note that concerns about prescribing antidepressants have led to an increase in pediatrician referrals of depressed adolescents, but they are unable to see all adolescents who need their care. There are not enough health care providers.
Fortuna said it’s important to note that the increase in suicide rates may be due to factors other than the boxed warning, adding, “We are in the midst of a mental health crisis in the United States, “There’s a lot of research being done on the increase in suicides.” Suicide rates over the past decade have increased during the pandemic. ”
Although it’s difficult to account for all potential causes in one study, the authors tried to take many things into account, so “this result is at least worth serious consideration,” Fortuna said. Ta.
Additionally, Kao-Ping Chua, Ph.D., associate professor of pediatrics at the Susan B. Meister Center for Child Health Evaluation and Research at the University of Michigan, said that the findings of a sharp decline in antidepressant use technically mean said that it is based on a decrease in Faculty of Medicine. Chua was not involved in the research.
However, it is important to note whether this means inappropriate withholding of antidepressants from young people with severe depression, or discontinuation of antidepressant treatment from young people who have never taken or no longer need to take these drugs. It is unclear whether that means,” Chua added in an email.
Another limitation was that the review focused on the short- to medium-term impact of a warning issued 20 years ago, Chua said.
“We don’t know if these effects are continuing,” he added. “We have reason to suspect that they are not doing so. For example, in our previous research, we found that antidepressants in female adolescents and young adults during the COVID-19 pandemic It shows that there was a sharp increase in drug administration, and this increase occurred despite the FDA’s black box warning.”
If you notice sudden changes in your child’s behavior or mood, including sleep, social life, attitude, school performance, concentration, and interest in activities, your child may be suffering from depression. Addressing this issue can be a complex process with concerns about how to treat the condition without putting children at risk of further harm.
“It’s true that the decision to start antidepressant treatment should not be taken lightly, but frankly that’s true of any long-term medication,” Chua says. “Every drug has potential benefits and potential side effects. The question is whether the former is likely to outweigh the latter.”
Treatment options, including various treatments, should be discussed with clinicians who spend time with young patients and their families to discuss the pros and cons so they can make informed decisions, Chua said. .
“No questions should be off-limits,” Fortuna said. “I also believe the intent of the FDA warning is good, to increase physician oversight of suicidal thoughts and behavior.”
Young people with depression “need to be fully evaluated and closely monitored if they are started on antidepressants, especially if they are prescribed drugs,” she added.
Potential side effects usually go away within a few weeks, but if they don’t, your health care provider may recommend another medication. Fortuna said each young person has a different level of risk, needs and circumstances, and antidepressants can be lifesaving.
