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22 Psychiatric for Monitoring in Primary Care

Medication Warnings, Precautions, and Adverse Events Comments Class: SSRI Boxed Warnings: Suicidality Used much less than SSRIs in the group of eight Indications: Warnings and Precautions: Similar to other SSRIs medications for prescribing, probably because it has no Adult: OCD Adverse Events: Similar to other SSRIs FDA indication for MDD or any disorder. Still Child/Adolescent: OCD (10-17 years) somewhat popular as a for OCD. Uses: Anxiety, OCD Monitoring: Same as other SSRIs : Suicidality. , one of the SSRIs in the group of Indications: Warnings and Precautions: Similar to other SSRIs medications for prescribing, is an active metabolite of Adult: MDD Adverse Events: Similar to other SSRIs citalopram. Escitalopram reportedly has fewer AEs and Child/Adolescent: None less interaction with hepatic metabolic enzymes than Uses: Anxiety, MDD, OCD citalopram but is otherwise essentially identical. Citalopram offers no advantage other than price, as Monitoring: Same as other SSRIs escitalopram is branded until 2012. Boxed Warnings: Suicidality. Paroxetine used much less than the SSRIs for Indications: Warnings and Precautions: Similar to other SSRIs prescribing, probably because of its nonlinear kinetics. Adult: MDD, OCD, , Generalized Anxiety Adverse Events: Similar to other SSRIs A study of children and adolescents showed doubling Disorder, Disorder, Posttraumatic Stress Disorder the dose of paroxetine from 10 mg/day to 20 mg/day Child/Adolescent: None resulted in a 7-fold increase in levels (Findling et Uses: Anxiety, MDD, OCD al, 1999). Thus, once metabolic enzymes are saturated, paroxetine levels can increase dramatically with dose Monitoring: Same as other SSRIs increases and decrease dramatically with dose decreases, sometimes leading to adverse events. Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011.

Medication Warnings, Precautions, and Adverse Events Comments Class: SNRI Boxed Warnings: Suicidality Venlafaxine was compared to a second SSRI in children Indications: Warnings and Precautions: syndrome, and adolescents with who had not responded Adult: MDD sustained hypertension, mydriasis, discontinuation to initial treatment with an SSRI (TORDIA study; Brent Child/Adolescent: None symptoms — especially anxiety and , et al, 2008). The second SSRI and venlafaxine showed decreased appetite and weight, height deceleration, comparable efficacy, however, venlafaxine was Uses: Anxiety, MDD activation of /, hyponatremia, associated with more adverse events and Monitoring: BP, HR, Ht, Wt, suicidality , increased risk of bleeding events, serum discontinuations. cholestoral elevation, interstitial lung disease and eosinophilic pneumonia Adverse Events: Asthenia, sweating, nausea, , , vomiting, , dry mouth, , nervousness, anxiety, tremor, blurred vision, abnormal ejaculation/orgasm and impotence in men Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011.

Medication Warnings, Precautions, and Adverse Events Comments Class: Boxed Warnings: Suicidality Venlafaxine was compared to a second SSRI in children Indications: Warnings and Precautions: , and adolescents with depression who had not responded Adult: MDD sustained hypertension, mydriasis, discontinuation to initial treatment with an SSRI (TORDIA study; Brent Child/Adolescent: None symptoms — especially anxiety and insomnia, et al, 2008). The second SSRI and venlafaxine showed decreased appetite and weight, height deceleration comparable efficacy, however, venlafaxine was Uses: Anxiety, MDD activation of mania/hypomania, hyponatremia, associated with more adverse events and Monitoring: BP, HR, Ht, Wt, suicidality seizures, increased risk of bleeding events, serum discontinuations. cholestoral elevation, interstitial lung disease and eosinophilic pneumonia Adverse Events: Asthenia, sweating, nausea, constipation, anorexia, vomiting, somnolence, dry mouth, dizziness, nervousness, anxiety, tremor, blurred vision, abnormal ejaculation/orgasm and impotence in men Boxed Warnings: Suicidality The most selectively of the TCAs, Indications: Warnings and Precautions: Seizures, orthostatic clomipramine is used for refractory OCD. Adult: OCD decreases in BP and increases in HR, , Child/Adolescent: OCD (8-17 years) confusion, mania or hypomania, hepatic enzyme increases, hematologic changes, hyperthermia, sexual Uses: Refractory OCD dysfunction, , withdrawal symptoms with Monitoring: Orthostatic BP, HR, blood levels, EKGs to rule out abrupt discontinuation prolonged QTc, suicidality Adverse Events: Gastrointestinal, including dry mouth, constipation, nausea, dyspepsia, and anorexia; complaints, including somnolence, tremor, dizziness, nervousness, and myoclonus; genitourinary complaints, including changed , ejaculatory failure, impotence, and micturition disorder; and other miscellaneous complaints, including fatigue, sweating, increased appetite, weight gain, and visual changes Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011.

Medication Warnings, Precautions, and Adverse Events Comments Class: OTHER ANTIDEPRESSANTS Buproprion Boxed Warnings: Suicidality Because of its structural similarity to , Indications: Warnings and Precautions: Seizures, , is sometimes used to treat both depression Adult: MDD agitation and insomnia, psychosis and confusion, and symptoms of ADHD. Child/Adolescent: None weight gain or loss, allergic reactions, hypertension Uses: Depression, ADHD Adverse Events: Agitation, dry mouth, insomnia, /, nausea/vomiting, constipation, Monitoring: BP, HR, HT, WT, suicidality and tremor Adverse Events: Somnolence, increased appetite, Mirtazapine is a tetra-cyclic atypical . It is Indications: weight gain, dizziness associated with more somnolence, appetite increase and Adult: MDD weight gain than other antidepressants. Child/Adolescent: None Uses: Depression Monitoring: Ht, Wt, suicidality

Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011.

Medication Warnings, Precautions, and Adverse Events Comments Class: (azaspirone ) Boxed Warnings: None Buspirone is one of the safest and easiest to monitor of Indications: Warnings: Co-administration with an MAOI can psychiatric medications used to treat children and Adult: Anxiety cause elevated blood pressure adolescents. However, two large, multisite 6-week Child/Adolescent: None Precautions: Interference with cognitive and motor RCTs found no significant differences between

performance, potential for withdrawal reactions in buspirone and with regard to the symptoms of Uses. Anxiety //anxiolytic -dependent patients, generalized (GAD) following doses Monitoring: None beyond general health possible concerns (e.g., a syndrome of restlessness) recommended for the treatment of GAD in adults. shortly after initiation of treatment () Boxed Warnings: None Primarily because of the possibility of physical and Indications: Warnings: Worsening or emergence of depression, psychological dependence with prolonged use of Adult: Acute anxiety suicidality, respiratory depression, interference with , lorazepam is generally recommended Child/Adolescent: None cognitive and motor performance, physical and only for short-term use (days to a few weeks) for Uses: Acute anxiety psychological dependence, risk of use in pregnancy, treatment of acute and severe anxiety following a withdrawal symptoms trauma or preceding a medical procedure. Monitoring: Pregnancy testing Precautions: Paradoxical reactions (i.e., behavioral disinhibition), should not be used with . Adverse Events: In a sample of about 3500 adult patients treated for anxiety, the most frequent adverse reaction was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%) (benzodiazepine) Boxed Warnings: None Clonazepam is similar to lorazepam, except for its Indications: Warnings: Interference with cognitive and motor shorter half-life and once daily dosing. Adult: Panic disorder performance, suicidality, physical and psychological Child/Adolescent: None dependence, risk of use in pregnancy, withdrawal

symptoms. Uses: Acute anxiety Precautions: Worsening of seizures, hypersalivation,

should not be used with alcohol Monitoring: Pregnancy testing Adverse Events: Somnolence, coordination abnormal, ataxia, depression Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011.

Medication Warnings, Precautions, and Adverse Events Comments Class: SECOND GENERATION Boxed Warnings: None Risperidone was the first second generation Indications: Warnings and Precautions: Neuroleptic malignant (SGA) approved by the FDA (in 1993) for Adult: Schizophrenia, acute manic or mixed episodes associated syndrome, tardive dyskinesia, hyperglycemia and marketing in the United States. It, along with the other with mellitus, hyperprolactinemia, orthostatic SGAs, is most commonly used to treat bipolar spectrum Child/Adolescent: Schizophrenia (13-17 years), acute manic or , leucopenia, neutropenia and disorders. It is generally effective and safe for short- mixed episodes (10-17 years), “irritability” associated with agranulocytosis, potential for cognitive and motor term use, but there are concerns about adverse effects of autistic disorder (5-16 years) impairment, seizures, dysphagia, , TTP, long-term use, such as , diabetes, metabolic Uses: Schizophrenia spectrum disorders, bipolar spectrum disruption of body temperature regulation, syndrome and tardive dyskinesia. disorders, “irritability” in effect, suicidality Adverse Events: Most common adverse reactions in Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL clinical trials (≥10%): somnolence, increased appetite, cholesterol, triglycerides, abnormal involuntary movements fatigue, insomnia, sedation, parkinsonism, , vomiting, cough, constipation, nasopharyngitis, drooling, rhinorrhea, dry mouth, abdominal pain upper, dizziness, nausea, anxiety, headache, nasal congestion, rhinitis, tremor, rash Boxed Warnings: Suicidality with antidepressant Marketed since 1997, quetiapine is associated with more Indications: somnolence than other SGAs. Adult: Schizophrenia, manic episodes associated with bipolar I or Warnings and Precautions: Neuroleptic malignant II disorder syndrome, hyperglycemia and diabetes mellitus, Child/Adolescent: Schizophrenia (13-17 years), manic episodes hyperlipidemia, weight gain, tardive dyskinesia, associated with bipolar I disorder (10-17) , increased blood pressure, Uses: Schizophrenia & bipolar spectrum disorders leucopenia, neutropenia and agranulocytosis, cataracts Adverse Events: Most common adverse events in Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL clinical trials in children and adolescents (incidence cholesterol, triglycerides, abnormal involuntary movements ≥5% and twice placebo): somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased Boxed Warnings: Suicidality with antidepressant Marketed since 2002, aripiprazole has a somewhat Indications: drugs different than other SGAs. It is Adult: Schizophrenia, acute treatment-manic or mixed episodes Warnings and Precautions: Neuroleptic malignant associated with less weight gain than other SGAs except of bipolar I disorder, maintenance treatment-bipolar I disorder, syndrome, tardive dyskinesia, hyperglycemia and . adjunct treatment-MDD diabetes mellitus, orthostatic hypotension, leucopenia, Child/Adolescent: Schizophrenia (13-17 yrs), manic or mixed neutropenia and agranulocytosis, episodes (10-17 yrs), “irritability” associated with autistic seizures/convulsions, potential for cognitive and disorder (6-17 yrs) motor impairment Adverse Events: Most common adverse reactions in Uses: Schizophrenia & bipolar spectrum disorders, “irritability” clinical trials in children and adolescents (incidence in autism ≥5% and twice placebo): somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL salivary hypersecretion, dizziness , tremor, sedation, cholesterol, triglycerides, abnormal involuntary movements fatigue, drooling

Ziprasidone Boxed Warnings: None Marketed since 2001, ziprasidone is associated with less Indications: Warnings and Precautions: QT interval weight gain than other SGAs. Because of its potential Adult: Schizophrenia, manic or mixed episodes associated with prolongation, neuroleptic malignant syndrome, to prolong the QT interval, ECG monitoring is needed. bipolar I disorder, adjunctive maintenance therapy of bipolar I tardive dyskinesia, hyperglycemia and diabetes disorder, agitation in schizophrenic patients (intramuscular mellitus, rash, orthostatic hypotension, leucopenia, injection) neutropenia and agranulocytosis, seizures, potential Child/Adolescent: None for cognitive and motor impairment Uses: Schizophrenia and bipolar spectrum disorders Adverse Events: Most common adverse reactions in clinical trials (incidence ≥5% and twice placebo): Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL Somnolence, extrapyramidal symptoms, dizziness, cholesterol, triglycerides, abnormal involuntary movements, QTc akathisia, abnormal vision, asthenia, vomiting on ECG Boxed Warnings: None Marketed since 1996, olanzapine is associated with Indications: Warnings and Precautions: , neuroleptic more weight gain and related metabolic in Adult: Schizophrenia, acute treatment of manic or mixed malignant syndrome, hyperglycemia, hyperlipidemia, adolescents than other SGAs (Sikich et al 2008; Correll episodes associated in bipolar I disorder weight gain, tardive dyskinesia, orthostatic et al 2009). Child/Adolescent: Schizophrenia (13-17 years), manic or mixed hypotension, leucopenia, neutropenia and episodes of bipolar I disorder (13-17 years) agranulocytosis, seizures, potential for cognitive and Uses: Schizophrenia & bipolar spectrum disorders motor impairment, hyperprolactinemia. Adverse Events: Most common adverse reactions in Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL clinical trials of adolescents (≥5% and at least twice cholesterol, triglycerides, abnormal involuntary movements that for placebo): sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth. Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011.

Medication Warnings, Precautions, and Adverse Events Comments Class: FIRST GENERATION ANTIPSYCHOTICS Boxed Warnings: None Perphenazine, a “mid-potency” antipsychotic, was Indications: Warnings and Precautions: Tardive dyskinesia, shown to have comparable effectiveness as the SGAs in Adult: Schizophrenia neuroleptic malignant syndrome, leucopenia, a large study of adults with schizophrenia (the “CATIE” Child/Adolescent: None neutropenia, agranulocytosis, hyperprolactinemia, study; Lieberman et al. 2005). In the CATIE study, Uses: Schizophrenia spectrum disorders, bipolar spectrum potential for cognitive/motor impairment, impaired perphenazine was associated with less weight gain and disorders liver function metabolic side effects than the SGAs. Adverse Events: Acute dystonic reaction, Monitoring: HT/WT, glucose, HbA1c, cholesterol extrapyramidal symptoms, withdrawal-emergent (total/LDL/HDL), triglycerides, liver enzymes, abnormal dyskinesia, akathisia, somnolence, drowsiness, involuntary movements autonomic effects (e.g., dry mouth, GI upset, blurry vision) Boxed Warnings: None Haloperidol, a “high potency” antipsychotic, has been Indications: Warnings and Precautions: QT interval prolongation, marketed in the US for over 50 years; it was the most Adult: Schizophrenia, control of tics in Tourette’s Disorder tardive dyskinesia, neuroleptic malignant syndrome, commonly prescribed antipsychotic in children and Child/Adolescent: None leucopenia, neutropenia and agranulocytosis, adolescents prior to the introduction of the SGAs in the

hyperprolactinemia, seizures, potential for cognitive 1990s. It is associated with more neurologic adverse Uses: Schizophrenia spectrum disorders, bipolar spectrum and motor impairment, impaired liver function events, but less weight gain and metabolic adverse disorders, tics Adverse Events: Acute dystonic reaction, events than the SGAs.

extrapyramidal symptoms, withdrawal emergent Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL dyskinesia, akathisia, somnolence, drowsiness, cholesterol, triglycerides, liver enzymes, abnormal involuntary various autonomic effects (e.g., dry mouth, GI upset, movements, QTc on ECG blurry vision) Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011.

Medication Warnings, Precautions, and Adverse Events Comments Class: MOOD STABILIZERS (Element of the alkali-metal group) Boxed Warnings: Toxicity closely related to serum Introduced in the US in the early 1960s, it was the Indications: levels; can occur close to therapeutic dose levels original mood stablilizer. It has clear, documented Adult: Manic episodes of , maintenance treatment Warnings: Very high risk of toxicity: significant evidence of effectiveness for acute and maintenance for BPAD cardiovascular or renal disease, severe debilitation, treatment for mania and bipolar disorder in adults. Child/Adolescent: Appears to have “grandfathered” indication dehydration, sodium depletion, taking or There has been no well-powered study for mania in for mania for ages >12 angiotensin converting enzyme (ACE) inhibitors. children and adolescents, in large part because of the Uses: Acute mania in bipolar disorder, also maintenance therapy Chronic use may lower renal concentrating ability, ethical and practical difficulties with doing placebo- can present as nephrogenic diabetes insipidus, with controlled studies. Evidence is mixed from several Monitoring: Pregnancy testing, serum levels, ECG, CBC, polyuria/polydipsia. Encephalopathic syndrome (i.e., smaller studies (Geller et al 1998, Kafantaris et al 2004, functions, renal function weakness, lethargy, fever, tremulousness and Kowatch et al 2007). Its indication for 12-17 year olds

confusion, leukocytosis, extrapyramidal symptoms, is not based on rigorous safety and efficacy data. elevated serum enzymes, BUN and FBS) may occur Unpopular with children and adolescents because of with lithium and a neuroleptic, often haloperidol. common side effects and the need for repeated Precautions: Hypothyroidism, impaired mental or venipunctures for serum level monitoring. physical abilities, any concomitant medications, i.e., diuretics, ACE inhibitors, , Adverse Events: Mild <1.5 mEq/L; Mild/moderate 1.5-2.5 mEq/L; Moderate/severe ≥2.0 mEq/L. <2.0 mEq/L: early signs of toxicity-diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination; At higher levels: giddiness, ataxia, blurred vision, , large output of dilute urine; At >3.0 mEq/L: complex clinically with multiple organs and organ systems Valproic Acid () Boxed Warnings: Hepatotoxicity — can be fatal, Valproic acid to treat mania in adults is supported by Indications: usually in first 6 months of use in children <2 years. substantial data. A yet unpublished, 24-week RCT had Adult: Acute treatment of manic episodes associated with bipolar Teratogenic, includes neural tube defects, e.g., spina response rates of divalproex = 54%, lithium = 42% and disorder, therapy of complex partial seizures and simple and bifida. Pancreatitis — can be fatal, hemorrhagic cases placebo = 29% (Kowatch et al 2007). A recent, complex absence seizures, prophylaxis of migraine Warnings and Precautions: Suicidality, industry-funded, multisite RCT in youth with mania and Child/Adolescent: None for psychiatric disorders thrombocytopenia, multiorgan hypersensitivity bipolar disorder did not show efficacy of valproic acid Uses: reaction, hypothermia, hyperammonemia, CNS versus placebo (Wagner et al 2009). The usefulness of “depression” when used with sedating drugs. Hepatic valproic acid in child psychiatric disorders is debatable Monitoring: Pregnancy testing, serum levels, CBC, liver function enzyme induction can affect many other drug levels given that the only published RCT of valproate for tests Adverse Events: Most common adverse reactions in mania in youth found no effect. clinical trials of mania (incidence ≥5% & >5% above placebo): Nausea, vomiting, somnolence, dizziness Carbamazepine/Oxycarbamazepine (anticonvulsant) Boxed Warnings: Serious, potentially fatal Carbamazepine was introduced in the US in 1968 for Indications: dermatologic reactions (toxic epidermal necrolysis treatment of seizures but has well-documented efficacy Adult: None for psychiatric disorders and Stevens-Johnson Syndrome), aplastic anemia, for treating mania in bipolar disorder in adults. There Child/Adolescent: None for psychiatric disorders agranulocytosis have been no RCTs in children and adolescents with Uses: Mood dysregulation Warnings and Precautions: Suicidality. Can affect bipolar disorder. The medication can be difficult to plasma levels of concomitant agents manage because of its numerous drug interactions Monitoring: CBC with , serum levels, Chinese ancestry- Adverse Events: The most frequently observed mediated by hepatic P450 enzymes. test for HLA-B*1502 before starting treatment adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting Lamotrigine (anticonvulsant) Box Warnings: Life-threatening rash (e.g., Stevens- There are no RCTs of lamotrigine in children and Indications: Johnson syndrome), toxic epidermal necrolysis, adolescents. Adult: Maintenance treatment of bipolar disorder, including higher risk in: youth than adults, use with valproate, depressed mood exceed recommended initial dose/dose escalation. Child/Adolescent: None in psychiatry May be benign — unable to predict if serious rash, Uses: Mood stabilizer stop at first sign unless clearly not drug-related. Warnings and Precautions: Hypersensitivity reaction, Monitoring: CBC and liver function studies suicidality, acute multiorgan failure, blood dyscrasias, clinicial worsening and emergence of new symptoms in bipolar disorder, aseptic meningitis, medication errors because of name similarities to other drugs Adverse Events: >5% in adult bipolar studies: nausea, insomnia, somnolence, back/abdominal pain, fatigue, rhinitis, Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011.