A medication meant to lift spirits may be falling flat.<\/p>\n
New research<\/a> suggests that an antidepressant commonly prescribed to children and teens may not be as effective as once thought.\u00a0<\/p>\n 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. <\/p>\n Nearly one in five Americans ages 3 to 17 have been diagnosed with a mental, emotional or behavioral health condition. Rawpixel.com \u2013 stock.adobe.com<\/p>\n In the study, researchers in the UK and Austria analyzed data from 12 large clinical trials involving youths taking fluoxetine between 1997 and 2024.<\/p>\n Better known by its brand name Prozac, fluoxetine is one of the most widely prescribed antidepressants<\/a> for children and adolescents in the US. <\/p>\n It\u2019s 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.<\/p>\n But when the researchers analyzed the data, they found that fluoxetine appeared not to provide meaningful benefits for reducing depressive symptoms in children.<\/p>\n In fact, the study authors told the Guardian<\/a> that the medication was supposedly \u201cno better than placebo\u201d at relieving depression.<\/p>\n The findings 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.<\/p>\n Fluoxetine is the recommended first-line medication for depression in children and adolescents. Simone \u2013 stock.adobe.com<\/p>\n The drug also carries a black boxed warning from the FDA \u2014 the agency\u2019s strongest safety alert \u2014 cautioning that it can increase the risk of suicidal thoughts and behaviors in children, teens, and young adults up to 24.<\/p>\n \u201cIt 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,\u201d Mark Horowitz, an associate professor of psychiatry at Adelaide University and a co-author of the study, told the Guardian.\u00a0<\/p>\n Still, outside experts say the findings should be interpreted with \u201ccaution.\u201d<\/p>\n \u201cClinical guidelines weigh many factors beyond average effect size, including safety, feasibility, and patient preferences,\u201d professor Allen Young, chair of the Royal College of Psychiatrists\u2019 Academic Faculty, told the Guardian.<\/p>\n \u201cIt is important that prescribed medication demonstrate consistent evidence and safety data.\u201d<\/p>\n The review had initially sought to explain discrepancies between earlier clinical trials, which reported positive results, and a 2021 study<\/a> that suggested fluoxetine\u2019s benefits were not clinically meaningful in young people. <\/p>\n The researchers reportedly identified a \u201cnovelty bias\u201d in the early trials, which they said likely contributed to their more positive outcomes, while later studies apparently failed to replicate those initial findings. <\/p>\n Children and teens taking fluoxetine may experience decreased appetite or weight changes. Pixel-Shot \u2013 stock.adobe.com<\/p>\n The study comes as depression is on the rise among America\u2019s youth<\/a> \u2014 and so are the drugs meant to treat it. <\/p>\n Between 2016 and 2023, federal data show<\/a> that the share of adolescents ages 12 to 17 diagnosed with depression jumped 45%, climbing from 5.8% to 8.4% of the population.<\/p>\n In 2023 alone, 4.5 million young people suffered at least one major depressive episode, researchers found<\/a>. <\/p>\n