The US Food and Drug Administration (FDA) allows Prozac for children only to manage major depressive disorders and OCD (1). However, in adults, this antidepressant is used to treat depression, bipolar disorder, obsessive-compulsive disorder (OCD), bulimia nervosa (an eating disorder), and panic disorders.
The FDA recommends so because prolonged use of selective serotonin reuptake inhibitors (SSRIs) such as Prozac (a brand name for Fluoxetine) can have risks that require thorough evaluation before using them on the pediatric population.
Read on to know about the safety, side effects, possible risks, and the precautions you need to take while using Prozac for children.
Uses Of Prozac For Children
Data from several randomized controlled clinical trials indicate that the benefits of Fluoxetine for treating major depressive disorder (MDD) in children and adolescents outweigh its risks. Fluoxetine was reported to have notable effects superior to placebo (formulation without active ingredients, such as sugar pills). Therefore, it is primarily used in children for the following purposes.
- The acute phase treatment of MDD in child and adolescent outpatients with severe persistent depression (2).
- The prevention of relapse or extending time to relapse in pediatric MDD (3).
- Short-term or maintenance treatment of MDD or OCD in children aged eight years and older.
Scientific evidence suggests that Fluoxetine may be the drug of choice for treating MDD and anxiety disorders. However, for use in anxiety disorders in children, approval is restricted to anxiety associated with OCD. Experts believe that the medication should be reserved for patients with moderate to severe depression. Maximum benefit can be derived if the medication is combined with cognitive behavioral therapy (CBT) with proper monitoring in children and adolescents (4) (5).
Prozac Dosage For Children
You should give Prozac to your child only when prescribed by a doctor. The medication is available as a tablet or capsule to be taken by mouth. The dosage is as follows, depending on the condition (1).
- MDD: Initially 10mg to 20mg per day
- OCD: Initially 10mg per day
The dose may be adjusted by your child’s psychiatrist depending on your child’s body weight. Sustained maintenance therapy may be required where the dose may be gradually adjusted by your child’s doctor based on his/her response to the therapy.
Prozac Side Effects In Children
Prozac (Fluoxetine) acts by modulating the neurotransmitter serotonin and may have side effects. Consult your child’s doctor if side effect symptoms are severe or do not resolve (1) (6). Below are the various potential side effects of Prozac in children.
- Sleep disturbances (including insomnia)
- Dry mouth
- Acid reflux
- Weight loss
- Loss of appetite
- Excess sweating
- Difficulty concentrating
Severe side effects that require immediate medical attention are:
- Allergic reactions such as rash, hives, shortness of breath, or swelling of the hands, feet, face, lips, and/or tongue
- Abnormal bleeding or bruising
Serotonin syndrome is an adverse and potentially fatal side effect, which occurs if Prozac is taken with other drugs that affect serotonin levels. Symptoms of serotonin syndrome may include:
- Hallucination or delirium
- Muscle twitching and muscle incoordination
- Increased heartbeat rate (tachycardia)
- Fluctuations in blood pressure
- Nausea or vomiting
Precautions For Prozac Use In Children
You must keep the following precautions in mind when administering Prozac to children (7).
- Make sure your child is not allergic to any of the constituents of the formulation. Fluoxetine tablets or capsules contain starch, gelatin, silicone, titanium dioxide, iron oxide, hypromellose, hypromellose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, triethyl citrate, and synthetic colors as inactive ingredients. Seek medical help if you see any signs of allergy.
- Inform your child’s doctor about any other prescription or over-the-counter (OTC) medications that your child is taking or has taken in the past month.
- Tell all of your child’s healthcare providers about his/her Prozac use prior to any other treatment.
- Children should avoid activities that require alertness, such as riding a bicycle or skateboarding, until their bodies have become accustomed to Prozac.
- Closely monitor your child’s blood sugar level if he/she has diabetes.
- The tablets or capsules need to be swallowed whole. Do not break or crush them.
- If your child misses a dose, do not give a double dose. Give the next dose as scheduled.
- Do not stop giving the drug suddenly without consulting a doctor.
- The drug may cause low sodium levels (hyponatremia) in some children. Seek medical help if your child shows symptoms of weakness, passing out, or seizures, as these are symptoms of low sodium levels.
- Consult the healthcare provider if your daughter has changes in their menstrual cycles when taking Prozac. Priapism (painful, persistent penile erection) may occur in adolescent boys.
- Fluoxetine may increase suicidal thoughts in some children and adolescents. Inform your child’s doctor of any such behavior in the past or a family history of suicides.
- Keep all medications out of children’s reach in child-proof containers. Accidental overdose of Fluoextine can be fatal.
Provide your child’s psychiatrist with the required information to ensure you get the right prescription for Prozac. Experts suggest combining CBT with drugs, such as Prozac, for best outcomes in children with psychological problems. Make sure you report all side effects to your healthcare provider. Do not miss your child’s follow-up appointments to ensure proper monitoring of progress.
- Prozac is used to treat major depressive disorders and prevent relapse in children.
- The possible side effects of Prozac include anxiety, diarrhea, and insomnia.
- Inform healthcare providers about your child’s Prozac use before undergoing other treatments.
- G. J. Emslie et al.; (2007); A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression.
- Graham J Emslie et al.; (2008); Fluoxetine versus placebo in preventing relapse of major depression in children and adolescents.
- Xinyu Zhou et al.; (2020); Comparative efficacy and acceptability of antidepressants, psychotherapies, and their combination for acute treatment of children and adolescents with depressive disorder: a systematic review and network meta-analysis.
- E. Jane Garland et al.; (2016); Update on the Use of SSRIs and SNRIs with Children and Adolescents in Clinical Practice.
- Fluoxetine Pediatric Medication.