Antidepressant prescribed to millions is ‘no better than placebo’ for children — with greater side effects

A medication meant to lift spirits may be falling flat.

New research suggests that an antidepressant commonly prescribed to children and teens may not be as effective as once thought. 

Now, some experts are raising doubts about whether young people with depression should be taking the drug at all, citing concerns that the risk of potentially serious side effects may outweigh its benefits.

In the study, researchers in the UK and Austria analyzed data from 12 large clinical trials involving youth taking fluoxetine between 1997 and 2024.

Better known by its brand name Prozac, fluoxetine is one of the most widely prescribed antidepressants for children and adolescents in the US.

It’s recommended as a first-line pharmacological treatment for pediatric depression and is the only antidepressant approved by the FDA for treating major depressive disorder in children as young as 8.

But when the researchers analyzed the data, they found that fluoxetine appeared not to provide meaningful benefits for reducing depressive symptoms in children.

In fact, the study authors told The Guardian that the medication was supposedly “no better than placebo” at relieving depression.

The finding have led some experts to question whether the benefits of fluoxetine justify the risks for young patients, which can include weight gain, sleep disturbances and trouble concentrating.

The drug also carries a black boxed warning from the FDA — the agency’s strongest safety alert — cautioning that it can increase the risk of suicidal thoughts and behaviors in children, teens, and young adults up to 24.

“It is difficult to see how anyone can justify exposing young people to a drug with known harms when it has no advantage over placebo in its benefits,” Mark Horowitz, an associate professor of psychiatry at Adelaide University and a co-author of the study, told The Guardian. 

Still, outside experts say the findings should be interpreted with “caution.”

“Clinical guidelines weigh many factors beyond average effect size, including safety, feasibility, and patient preferences,” Professor Allen Young, chair of the Royal College of Psychiatrists’ Academic Faculty, told The Guardian.

“It is important that prescribed medication demonstrate consistent evidence and safety data.”

The review had initially sought to explain discrepancies between earlier clinical trials, which reported positive results, and a 2021 study that suggested fluoxetine’s benefits were not clinically meaningful in young people.

The researchers reportedly identified a “novelty bias” in the early trials, which they said likely contributed to their more positive outcomes, while later studies apparently failed to replicate those initial findings.

The study comes as depression is on the rise among America’s youth — and so are the drugs meant to treat it.

Between 2016 and 2023, federal data shows that the share of adolescents ages 12 to 17 diagnosed with depression jumped 45%, climbing from 5.8% to 8.4% of the population.

In 2023 alone, 4.5 million young people suffered at least one major depressive episode, researchers found.

At the same time, antidepressant use among young Americans is soaring. One study found prescriptions for 12- to 25-year-olds jumped 63% between 2016 and 2022.

The researchers stressed that even if fluoxetine’s benefits for depressed children and teens are in question, they shouldn’t be left without care.

“Recognition that antidepressants lack clinical meaningful average efficacy in this age group does not mean leaving depressed patients without support,” they cautioned.

“We should also avoid the situation that patients abruptly stop medication as this can create problematic withdrawal symptoms,” the study authors added.

Withdrawal symptoms from fluoxetine can include irritability, dizziness, headache, anxiety and flu-like symptoms such as fatigue and nausea.

“Patients who decide they wish to stop an antidepressant should be advised to consult a clinician expert in deprescribing,” the study authors recommended.