Not Approved for Pediatric Use

Psychiatric Drugs Not Approved for Pediatric Use by the FDA

Black Box Warnings (so-called because of the black border around its text - here is Paxil's) are often ignored by doctors who prescribe these medications off-label. State Medicaids dole out millions of taxpayer dollars monthly in prescription reimbursements for such off-label use.

These drugs are either not FDA approved for pediatric use for any Indication, or are not approved for specific Indications, or are only approved for specific Indications.

Generic Name	Also Marketed As	Black Box Warning	Inc'd Risk of Suicidality	Drug Class	Adverse Reactions	FDA-Approved For, Restrictions and Other Notes
Amitriptyline	Elavil	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Amoxapine	Asendin	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Aripiprazole	Abilify	X	√	Atypical Antipsychotic	X	Approved by the FDA on Nov 6, 2007 for the treatment of Schizophrenia in teenagers aged 13-17 [ref] and on Feb 29, 2008 approved for the acute treatment of manic and mixed episodes of Bipolar Disorder I ("Bipolar Disorder I" refers to recurrent episodes of mania and depression) in pediatric patients aged 10-17 [ref]; it is not approved by the FDA for use in pediatric patients with Depression [ref]
Bupropion	Budeprion, Wellbutrin, Zyban	X	√	Antidepressant	X	Not approved by the FDA for pediatric use for any Indication
Citalopram	Akarin, Celexa, Cipramil, Elopram, Seropram	X	√	SSRI	X	Not approved by the FDA for pediatric use for any Indication
Clomipramine	Anafranil	X	√	Antidepressant	*	Only approved by the FDA for use in pediatric patients age 10 and older diagnosed with Obsessive-Compulsive Disorder (OCD) - See Black Box Warning and this NIMH reference regarding approved patient age.
Clozapine	Clozaril, Leponex			Antipsychotic	X	According to this NIMH reference (last reviewed June 26, 2008), the approved patient age for Clozaril (clozapine) is 18 and older.
Desipramine	Norpramine	X	√	Antidepressant	X	Not approved by the FDA for pediatric use for any Indication
Doxepin	Sinequan	X		Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Duloxetine	Cymbalta, Yentreve	X	√	SNRI	X	Not approved by the FDA for pediatric use for any Indication
Escitalopram	Cipralex, Lexapro, Seroplex, Sipralexa	X	√	SSRI	X	Not approved by the FDA for pediatric use for any Indication
Fluoxetine	Fluctin, Fontex, Ladose, Prozac, Sarafem, Symbyax, Zactin	X	√	SSRI / Atypical Antipsychotic	X	Only approved by the FDA for Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD). Symbyax is a combination of Fluoxetine & Olanzapine.
Generic Name	Also Marketed As	Black Box	Inc'd Risk	Drug Class	Adverse Reactions	FDA-Approved For, Restrictions and Other Notes
Fluvoxamine	Depromel, Floxyfral, Fluvoxamine Maleate, Luvox	X	√	SSRI	X	Only approved by the FDA for use in pediatric patients diagnosed with Obsessive-Compulsive Disorder (OCD)
Imipramine Pamoate	Imipramine, Tofranil	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Isocarboxazid	Marplan	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Lamotrigine	Lamictal	X		Antipsychotic	X	Only approved for use in patients > 16 years old with seizures related to Lennox-Gastaut syndrome or in patients with partial seizures.
Maprotiline	Ludiomil	X	√	NRI	**	Not approved by the FDA for pediatric use for any Indication
Methylphenidate	Concerta, Daytrana, Equasym, Focalin, Metadate, Methylin, Ritalin			Stimulant	X	Not approved by the FDA for pediatric use in children under 6
Mirtazapine	Remeron, Zispin	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Nefazodone	Dutonin, Nefadar, Serzone	X	√	SNRI	X	Not approved by the FDA for pediatric use for any Indication
Nortriptyline	Allegron, Aventyl, Nortrilen, Pamelor	X		Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Olanzapine	Zyprexa			Atypical Antipsychotic	X	Zyprexa is approved by the FDA to treat mixed or manic episodes in adults who have a condition called Bipolar I Disorder and may also be used with Lithium or Valproate for short-term treatment of acute manic episodes of Bipolar Disorder [ref]. This NIMH reference states the approved age is 18 and older. There is no FDA approval for pediatric use.
Paliperidone	Invega			Atypical Antipsychotic	***	Only approved by the FDA for the treatment of Schizophrenia in adults [ref]. It has not been studied in children under 18 [ref].
Paroxetine	Aropax, Deroxat, Optipar, Paroxat, Paxil, Pexeva, Seroxat	X	√	SSRI	X	Not approved by the FDA for pediatric use for any Indication
Phenelzine	Nardil	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Generic Name	Also Marketed As	Black Box	Inc'd Risk	Drug Class	Adverse Reactions	FDA-Approved For, Restrictions and Other Notes
Protriptyline	Vivactil	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Quetiapine	Seroquel	X	√	Atypical Antipsychotic	X	The Black Box Warning, backed up by the product label, states Seroquel is not approved for use in pediatric patients.
Risperidone	Risperdal			Atypical Antipsychotic	X	Only approved by the FDA for treating Schizophrenia in teenagers aged 13-17, for short-term treatment of manic or mixed episodes of Bipolar Disorder I in pediatric patients aged 10-17, and for irritability associated with autism in children and teens aged 5-16 [ref], and [ref] which also lists safety information.
Selegiline	Eldepryl, Emsam	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Sertraline	Aremis, Daxid, Gladem, Lustral, Serlain, Zoloft	X	√	SSRI	X	Only approved by the FDA for use in pediatric patients diagnosed with Obsessive-Compulsive Disorder (OCD)
Tranylcypromine Sulfate	Parnate	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Trazodone	Deprax, Desyrel, Trazolan	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Trimipramine	Surmontil	X	√	Antidepressant	*	Not approved by the FDA for pediatric use for any Indication
Venlafaxine	Efectin, Effexor	X	√	SNRI	X	Not approved by the FDA for pediatric use for any Indication
Ziprasidone	Geodon, Zeldox			Atypical Antipsychotic	X	Not approved by the FDA for pediatric use [ref]

*	Individual Adverse Reaction listings have not yet been assembled for these Antidepressants. See this table for a list of Adverse Reactions attributed to taking Antidepressants.

Ludiomil (Maprotiline) appears in 2 Individual Safety Reports where the patient age is listed as "0" (newborn) suffering these Adverse Reactions: Atrial Septal Defect, Blood Creatine Phosphokinase Increased, Drug Exposure During Pregnancy, Facial Dysmorphism, Somnolence and Ventricular Septal Defect; it's reported as the Primary Suspect Drug causing Convulsion and Visual Disturbance in a 16 Year Old; it's reported in 58 Cases where no patient age is included, but some of the Adverse Reactions obviously affected mothers or unborn/newborn babies: Abortion Induced, Akinesia, Alveolitis Allergic, Aphasia, Asthenia, Atrial Septal Defect, Blood Creatine Phosphokinase Increased, Blood Pressure Decreased, Catatonia, Chorea, Circulatory Collapse, Depressed Mood, Drug Exposure During Pregnancy, Drug Interaction, Dyskinesia, Dysphemia, Echocardiogram Abnormal, Facial Dysmorphism, Feeling Abnormal, Hepatic Steatosis, Hypoglycaemia, Interstitial Lung Disease, Loss of Consciousness, Malaise, Mania, Mental Impairment, Movement Disorder, Myalgia, Nausea, Negativism, Pain In Extremity, Parkinsonian Gait, Parkinsonism, Peripheral Coldness, Pleurisy, Pneumonia, Poor Sucking Reflex, Regressive Behaviour, Rhabdomyolysis, Sensation of Heaviness, Somnolence, Staring, Status Epilepticus, Suicide Attempt, Thought Blocking, Thrombosis, Tic, Tremor, Ventricular Dysfunction, Ventricular Hypertrophy, Ventricular Septal Defect, Vomiting and Weight Decreased.

***

The following Adverse Reactions were included in 10 Individual Safety Reports sent to the FDA (possibly during the clinical trials as each report's drug is listed as "Blinded: Paliperidon Palmitate") where Paliperidone was identified as the Primary Suspect Drug: Abnormal Behaviour, Acute Lymphocytic Leukaemia (2 Cases), Aggression (3 Cases), Cardiac Arrest, Condition Aggravated, Death (2 Cases), Delusion, Pancytopenia (3 Cases - this is a deficiency of all three cellular components of the blood: red cells, white cells, and platelets), Paranoia, Psychotic Disorder (4 Cases), Rash Generalised, Schizophrenia (3 Cases reporting Paliperidone causing the condition it allegedly treats). Patient age was not included in any of the reports.