FDA Approves Lexapro (SSRI Pharmaceutical) for Kids Ages Seven and Older

EDITOR’S SUMMARY: Whatever camp you’re in: Children should be allowed to take psychotropic (affects mood, perception, thoughts, and behavior) pharmaceuticals under specific conditions; children should not be allowed to consume these meds no matter what, or somewhere in the middle … it is a personal, individual choice. Regarding Lexapro, it can be a hard call to make. After all, there is a lot to consider, and you want the best experience and outcome for your child. Learn as much as you can, and pay attention to the research as well as your intuition to make an intelligent, deliberate decision.

The handling of the COVID-19 “pandemic” affected children’s mental well-being considerably. Yet well before the global pandemonium, pediatric mental health issues in the U.S. were on the rise. From 2006, across a ten-year period, a study examining U.S. emergency room visits published in the medical journal, Pediatrics, stated that incidents of minors inflicting purposeful self-harm soared 329%. Children treated for substance abuse increased 159%, while minors treated for any mental health disorder rose 60% over that time.

Every year, an estimated half a million of the nation’s 73 million children show up at emergency rooms with mental health conditions, such as depression and attempted suicide. The U.S. government acknowledged “our country faces an unprecedented mental health crisis.”

Amidst this concerning backdrop, the U.S. Food and Drug Administration (FDA) approved a pediatric treatment specifically targeting generalized anxiety disorder (GAD). In May 2023, the drug escitalopram won FDA approval for use with children ages seven years and older who were diagnosed with GAD. 

Escitalopram is a class of antidepressant called a selective serotonin reuptake inhibitor (SSRI). The drug is commonly known under the brand name Lexapro, which has been on the market in the U.S. since 2002. It was originally distributed by Forest Laboratories, now owned by Allergan. Escitalopram has been used to treat major depressive disorder (MDD) in adults, and children ages 12 and older, as well as GAD in adults. And now, Lexapro is available as a treatment option for pediatric GAD.

Generalized anxiety disorder is marked by uncontrollable worry, so extreme it makes your ability to function in daily life difficult. This differs from occasional anxiety you may feel from time to time. Feeling worried or apprehensive now and then about money, health, self-worth, and other concerns is common.

With generalized anxiety disorder, this worrying is excessive to the point it becomes difficult to sleep, and to tend to your daily tasks and responsibilities. These feelings can transform into a general fear of the unexpected, spiraling out of control to the point you can no longer regulate your stress. This state of heightened anxiety can persist over a prolonged period of time, and to be classified as GAD, it must last for at least six months.

Generalized anxiety disorder is a mental condition affecting nearly 7 million U.S. adults, and strikes children too. Some estimates place the number of GAD-affected children at 1 in 8. The FDA approved Lexapro for minors based on an 8-week clinical trial in April 2023. This named the drug as effective and safe for kids between 7 and 17 years of age. As for its efficacy … From “Lexapro for Children: Drug With No Meaningful Benefit and Increased Suicidality Gets FDA Approval”:

“The researchers randomly assigned 275 kids aged 7-17 with a diagnosis of generalized anxiety disorder (GAD) to either receive Lexapro or a placebo. The trial lasted for eight weeks.

The findings were mixed. On the 30-point PARS-GAD anxiety measure, there was a mean difference of 1.42 points between the drug and placebo group (statistically significant at p <0.05, but not significant at p <0.01). This is the finding that supports the FDA’s approval.

However, the researchers also found that there was no difference between groups in response to the drug, remission from anxiety, and overall functioning. That is, about the same number of kids, whether on the drug or on placebo, experienced clinical improvement (“response”) or no longer had anxiety (“remission”). Nor did the drug improve overall functioning.”

2023 wasn’t the first time escitalopram was made available to children. Lexapro’s use with minors was first approved in 2009, but for children 12 years of age and older with major depressive disorder. The FDA based its approval partly on adult usage, stating the data could be extrapolated to children. Since that time, the number of children taking Lexapro has doubled.

Interestingly, the original pharmaceutical company behind Lexapro, Forest Laboratories, was charged back in 2009 by the U.S. Justice Department for illegally marketing Lexapro to children. In addition, they were cited for paying kickbacks to pediatricians for prescribing the drug, even though Lexapro’s safety and efficacy for minors had not been proven at the time. Forest Labs eventually admitted guilt for these charges and paid millions of dollars in fines.

The Mechanism

Lexapro works by increasing the level of serotonin in your brain. Your body naturally produces serotonin to act as a chemical messenger between your brain and other parts of your body. Serotonin regulates a number of human behaviors, including mood, memory, anger, fear, and other stress responses. It affects your appetite and how your bowels work. It’s involved in blood clotting and healing wounds. Serotonin also works with melatonin to regulate your sleep cycle.

Once serotonin transmits its message to the brain, your body reabsorbs it. SSRIs block this absorption, which results in more serotonin in your brain. Increasing your brain’s serotonin level can be effective to offset low serotonin, which is associated with mental health disorders, such as depression and anxiety.

This boosting of serotonin contributed to the idea that mental illness was the result of chemical imbalance in the brain. Starting in the 1980s, this idea rose to public prominence through pharmaceutical statements and advertisements. These were made by respected medical organizations, such as the American Psychiatric Association (APA), and the National Institutes of Health (NIH). This is a dominant reason why many people have been led to believe the only solution to correct a mental health imbalance is with medication.

Today, this rationale is known to be a fallacy, since it is now recognized that a variety of factors contribute to the development of mental instability. These include childhood trauma, stressful events such as the death of a loved one, and unhealthy lifestyle choices, including a poor diet and smoking.

Psychiatrist and researcher Nassir Ghaemi explained serotonin reuptake inhibitor drugs in regards to the inherent issue: 

“[SSRIs] reduce symptoms of depression somewhat, just as aspirin reduces symptoms of fever. Their mechanism, increasing serotonin, may have nothing at all to do with the psychiatric diseases that cause depression, such as manic-depressive illness, just as the mechanism of aspirin has nothing to do with the infectious diseases that cause fever.”

Therefore, it’s important to recognize that Lexapro isn’t a cure. It’s a tool you may choose to opt for in conjunction with other treatments, such as psychotherapy. To that end, the optimal duration for pediatric patients using a psychotropic medication, such as Lexapro, is a period of a few months to a year, according to scientific research. 

This is the time period found to help achieve a remission of the condition when medication is combined with psychotherapy. Remission is defined as the patient no longer exhibiting the clinical criteria for major depressive disorder (MDD) or generalized anxiety disorder (GAD), so that they can move away from the need for medication.

However, and indeed unfortunately, pharmaceuticals are often prescribed without counseling. A 2023 analysis of anxiety treatments between 2006 to 2018 showed the number of children diagnosed with an anxiety disorder increased over that period. At the same time, treatments employing therapy decreased, indicating children were treated only with drugs. In fact, the likelihood of receiving medication alone rose significantly in the last four years of the period compared to the start.

A contributing factor to this is a lack of pediatric therapists in some locations, such as in rural areas. In these cases, the option for telehealth—working with a healthcare professional virtually via online meetings—may provide access to a pediatric therapist. This is key, because according to Janine Domingues, a psychologist at the Child Mind Institute, an increased reliance on medication alone is a problem. She explained

“The reason we don’t recommend just medication alone, particularly with children and adolescents, is because we know that the skills gained through therapy are an important addition. Not only do we want to see kids not suffering with anxiety symptoms, we also want to see them functioning, going to school, having friends.” 

Risks for Children Using Lexapro

It’s important to note that although the FDA approved Lexapro for children, the drug possesses several downsides that must be carefully weighed by a healthcare provider before adding it to a treatment plan. For instance, because serotonin does so much for your body, the number of side effects from Lexapro is vast. These include headaches, nausea, insomnia or somnolence, fatigue, constipation, indigestion, sexual and menstrual dysfunction. Additionally, a serious “side effect” occurs when too much serotonin builds up in the body. This is called serotonin syndrome, which can cause seizures and death. 

The risk of serotonin syndrome is greatest when taking Lexapro for the first time, increasing the dosage, or when combined with another drug. Caution is also advised when using Lexapro with particular herbal supplements, such as ginseng and St. John’s wort, that also act on your serotonin levels.

Another major side effect is the fact that SSRI drugs, such as Lexapro, significantly increase the risk of suicide. In the 2023 clinical trial used by the FDA to assess Lexapro’s safety and effectiveness for children, the drug produced a sixfold increase in suicidal tendencies.

Consequently, the FDA warns that Lexapro can escalate the risk of suicide in a child, and requires a warning on the drug that boldly states:

“Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.”

Mayo Clinic, “Antidepressants for children and teens,” answers the question, “Should children be treated with antidepressants at all?”:

“The warning about a possible link between antidepressants and suicidal thoughts does not mean that antidepressants should not be used in children. Nor is the warning meant to frighten people away from antidepressants. However, the warning should be taken as a caution to carefully weigh the pros and cons of using antidepressants in children and teenagers against the real risk of suicide as a result of untreated depression.

For many children and teens, antidepressants are an effective way to treat depression, anxiety, obsessive-compulsive disorder or other mental health conditions. If these conditions aren’t treated effectively, your child may not be able to lead a satisfying, fulfilled life or do everyday activities.”

An important consideration when taking Lexapro is understanding the time it takes for the drug to affect a change in mental health. It can take weeks before you see a benefit appear, as it gradually builds up serotonin levels in your body. Sometimes Lexapro isn’t effective, and switching to another medication may be recommended. Other times, a tolerance for the drug builds up, requiring higher doses, which can increase the risk of serotonin syndrome. And similarly to how it takes time to build up in your body, if you decide to discontinue its use, you must gradually reduce it to allow your body to adjust. 

There may be further health complications with long-term use over several years. Research indicates those who use antidepressant drugs have double the likelihood of developing dementia, or another form of cognitive impairment later in life, especially if the medication was taken before age 65.

Other risks come with long-term use, especially without therapy to build a path away from relying on pharmaceuticals. Be cautious, as psychological drug dependence can develop. And for those of child-bearing age, Lexapro can cause birth defects in an unborn baby, such as spina bifida, and damage to the heart that can lead to the baby’s death.

Psychotropic medications are also linked to various forms of cognitive impairment, from blunting of emotions to producing violent behavior. One study measured an increase in violent crimes among those who took selective serotonin reuptake inhibitors.

Other Treatments for Your Consideration

Complementary and alternative remedies to Lexapro are an option. Changes to diet is one key method, since about 95% of your body’s serotonin is produced in your gut. Science now understands your gut holds an outsized impact on your mood and emotions.

Eating unprocessed foods helps alleviate symptoms of depression and anxiety. Meanwhile, consuming foods high in refined sugar are harmful to your brain. They create inflammation and impaired brain function, which causes a decline in mental health that is linked to depression and anxiety.

Studies have also shown eating the standard American diet (SAD) increases the risk of depression by up to 35% higher than a Mediterranean or Japanese diet. These non-SAD diets are low in refined sugar, and high in fermented foods, (which act as probiotics), clean proteins, and nutritious fats.

Getting plenty of physical activity is a means to boost mental health. Research has shown exercise can treat mild to moderate depression as effectively as antidepressants. The way you move your body may range from weight training or playing a sport, to milder activities such as working in the garden, or taking a walk around the block.

Exercise affects your mental health by boosting serotonin in your body. It also increases endorphins and dopamine—hormones that promote positive feelings while reducing stress. Physical exertion also increases blood flow to the brain, which delivers nutrients helping to improve brain function.

The 3-3-3 rule for anxiety, also called the “Rule of Three,” is a mindfulness technique to help your child focus on the present moment, rather than on what might happen in the future, which fuels anxiety. This approach asks your child to identify three things they can see, three they can hear, and three they can touch or move.

Your child can also learn “5-5-5 breathing.” This involves breathing in for 5 seconds, holding that breath for 5 seconds, then breathing out for 5 seconds. This technique is useful for any child experiencing heightened emotions, such as anger. This practice can help bring their emotions into balance so they can make rational decisions. Moreover, several effective therapies for mental health disorders exist, including cognitive behavioral therapy (CBT), dialectical behavioral therapy (DBT), and eye movement desensitization and reprocessing (EMDR).

Transcranial magnetic stimulation (TMS) is a treatment for children you may want to consider. TMS uses electromagnetic pulses to stimulate parts of the brain that regulate mood. The FDA approved its use in adults in 2008. A 10-year study of TMS applied to hundreds of minors found the technique to be safe for children as well. You may need to read between the lines to make this determination for yourself. 

Holistic alternatives to taking Lexapro also include acupuncture, spending more time in the sun, and taking certain types of herbal supplements, including St. John’s Wort and valerian. Because so many tools and options for treatment exist today, there is a good probability that a child with a mental health issue can learn to live with and manage their condition until it goes into remission. The outlook for generalized anxiety disorder is typically positive, as nearly 80% of patients with the condition improve with treatment within nine months.

If you’ve done your due diligence, and starting your child on Lexapro seems like the right decision, move forward with confidence. Without question, the best way to navigate through this challenge is to be well-informed about your options, try out different approaches, and if one doesn’t work, don’t give up. Continue learning and experimenting with a variety of solutions until you find the combination that works best for you and your family.


Published on February 22, 2024.

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