We ll Be Discussing. Pregnancy 4/24/2013

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1 Joe Wegmann, PD, LCSW The PharmaTherapist Are you receiving our free monthly e-newsletter? We ll Be Discussing The safety and efficacy track record of psychiatric medication in expectant mothers, older adults and youth Benefits, risks, and controversies associated with medication use in each of these groups will be analyzed Pregnancy There s a paucity of reliable data associated with psychiatric medication use during pregnancy Unknown risks engender physician reluctance to prescribe psychotropics 50 percent of all pregnancies are unplanned A considerable number of women are becoming pregnant while they re being treated for a mental illness 1

2 Pregnancy The best available evidence-based and anecdotal information indicates that most psychotropicsare relatively safe during pregnancy Treat or not to treat? In spite of safety factors, NOT treating pregnant women with a psychiatric diagnosis may be far riskier The most important indicator of a healthy baby is a healthy mother Important Risk Factors Psychiatric medications fall into FDA category C potential fetal risk cannot be ruled out Major risk factor is Teratogenesis (malformation of the fetus or fetal organs) Spinabifida (cleft spine); facial deformity; cleft palate Risk Factors (Cont) Behavioral teratogenesis Learning difficulties; developmental delays Residual effects on the newborn post-birth withdrawal symptoms (lack of crying, poor sleep, irritability) Drug effects on the breastfed infant 2

3 Psychotropic Medication Guidelines During Pregnancy All psychiatric medications cross the placental barrier All are secreted in breast milk Antidepressants Antidepressants do not increase the baseline rate (1% - 3%) for major malformations Increased rate of spontaneous abortion in some studies SSRIs (Prozac, Zoloft, Paxil, Lexapro, etc.) are not associated with any teratogenesis Paxil is an exception and is off limits in the first trimester because of Category D status 30 percent of infants with third trimester exposure demonstrate post-birth withdrawal Zoloft is safest AD during pregnancy Present in breast milk Lithium Generally not recommended during pregnancy First trimester exposure associated with fetal cardiac irregularities (abnormal heart rate, EKG changes) Neonatal effects include impaired respiration and renal impairment Significant concentrations in breast milk; nursing contraindicated 3

4 Antipsychotics Haldol is the agent most studied and is not linked to congenital malformations during the first trimester Haldol is the preferred antipsychotic for use during pregnancy, but EPS a problem Second-generation antipsychotics (Risperdal, Zyprexa, Abilify, etc.) have not been sufficiently studied All of the newer antipsychotics carry a risk of metabolic syndrome but less movement disorders Benzodiazepines First trimester exposure increases the risk of cleft palate development Significant concerns are neonatal CNS depression and withdrawal symptoms Breast milk concentrations can cause sedation and slowed heart rate Anticonvulsants Depakote is an established teratogen and should be totally avoided during pregnancy Linked to long-term neurodevelopmental effects well into adolescence (expressive language and developmental delays; impaired intellectual performance) Lamictalappears to be more promising; does not increase the risk of major birth malformations 4

5 Psychotropic Medication Use In Older Adults The obvious first: Safe medication use in an aging population requires vigilance due to physiological factors Dosing concerns arise due to: Changes in body weight Slowed metabolism 40% reduction in liver and kidney drug clearance Start low; go slow is a must as a prescribing habit Older Adults Medication use generally increases with age Higher incidence of OTC and alternative drug use (Herbals and Supplements) In the U.S., those 65 and older make up 13% of the population. They account for 30% of prescriptions written and 60% of all OTCs purchased The incidence of drug interactions increases to 50% in those taking five medications per day Older Adults Changes in mental status can be drug-related Benzodiazepines and sedating antidepressants have been linked to falls and fractures Slowed response rates to medication can foster non compliance Advancing age is accompanied by less patience 5

6 Older Adults Memory decline makes collateral support a must Multiple pharmacies can be a significant problem: Encourage use of one source for the purchase of all medications Rx and OTC Children and Adolescents Mood Disorders Depression, using the same criteria as used for adults, is unquestionably diagnosable in children and adolescents Biological Vs. environmental Only Prozac consistently outperforms placebo for MDD and OCD in children and adolescents ages 8 and older Antidepressants and suicide Medications of choice in childhood onset Bipolar are lithium and Depakote Childhood Bipolar Disorder diagnosis has undergone a 40X increase in a decade and has become a fad. This has been fueled by influential prophets with an engaging storyline Disruptive Mood Dysregulation Disorder a lame cop-out that will foster DSM 5 s propensity for over-medicalization 6

7 Anxiety Disorders Medication management studies are sparse and inconclusive Mood stabilizer, second-generation antipsychotic use on the rise for the treatment of severe aggression, tantrums, destructive behavior Psychotic Disorders Adolescent onset between the ages of 11 and 15 Rare in children always question, it s likely something else Benefit-vs.-risk associated with antipsychotic use is a concern Attention Deficit Hyperactivity Disorder Some children are more scheduled than us Onset by age 7-8, as early as age 4 Untreated ADD: fifty percent of children develop substance abuse problems in late adolescence or early adulthood A disorder of executive dysfunction Overdiagnosed vs. underdiagnosed What parents should consider first 7

8 What Causes ADHD? Possible Causes Weak circuitry in the frontal lobes Manifests as deficits in norepinephrineand dopamine Genetic component increased risk for ADHD in first degree relatives Subtypes Predominantly inattentive type Combined type Predominantly hyperactive/impulsive type 8

9 ADHD Core Features Basic Issue: Mental distractibility Inattention Carelessness Difficulty sustaining attention Difficulty listening Failure to follow through on tasks Difficulty organizing activities Avoidance of activities requiring prolonged mental effort Forgetfulness Frequent distraction Frequent loss of materials required for activities Hyperactivity Fidgeting Leaving seat in class Inappropriate activity, such as running and climbing Difficulty playing quietly 9

10 Impulsivity Answering questions before they are completely stated Difficulty waiting for turn Often interrupts or intrudes on others Medications If it s ADD, meds work immediately Meds make life less hard for these kids 70-90% response rate Stimulants wake up the brain Mounting evidence of Omega3s in symptom reduction Generic name Trade name Dose forms available Usual dosing Bupropion Wellbutrin Wellbutrin75mg, 100mg BID or TID (at least 6 hours between doses) Wellbutrin SR, LA Wellbutrin100mg, 150mg, 300mg QD-TID (at least 8 hours between doses) Dextroamphetamine Dexedrine = Dextrostat Dextroamphetamine/ Amphetamine Dexedrine Spansule Adderall Dexedrine 5mg, 10mg Dextroamphetamine5mg, 10mg Dextrostat 5mg, 10mg Dexedrine Spansule5mg, 10mg, 15mg Adderall5mg, 10mg (and others) QD-TID (4-6 hour interval between doses) QD in AM QD, BID, TID (4-6 hour interval between doses) QD in AM Adderall XR AdderallXR 10mg, 20mg, 30mg Methylphenidate Ritalin Ritalin 5mg, 10mg, 20mg BID-TID Methylphenidate 5mg, 10mg, 20mg Ritalin SR Ritalin SR 20mg 8 hour duration 10

11 Generic name Trade name Dose forms available Usual dosing Ritalin LA Ritalin LA 20mg, 30mg, 40mg QD in AM MTS Metadate CD Metadate CD 20mg Concerta Daytrana Concerta18mg, 27mg, 36mg, 54mg Daytrana10mg, 15mg, 20mg, 30mg QD in AM QD in AM QD Dexmethylphenidate Focalin Focalin2.5mg, 5mg, 10mg 6 hour duration Atomoxetine NRI FocalinXR FocalinXR 5mg, 10mg, 20mg 12 hour duration Strattera (Nonstimulant) Strattera Capsules 10mg, 18mg, 25mg, 40mg, 60mg Single daily dose in AM or divided doses in AM and late PM Clonidine Catapres 0.1mg, 0.2mg, 0.3mg TID-QID Guanfacine Tenex 1mg, 2mg, 3mg BID-TID Enhancing Compliance Stimulants: Dosing after noon contraindicated Weight loss likely to be transient Claims regarding growth retardation are unfounded Common side effects: Insomnia, poor appetite, initial weight loss, GI upset Drug Holidays Dosage Range Chart Medications for ADD/ADHD BRAND NAME GENERIC NAME DAILY DOSAGE RANGE * Adderall dextroamphetamine/ amphetamine 5 mg 40 mg Adderall XR dextroamphetamine/ amphetamine 10 mg 30 mg Catapres clonidine 0.1 mg mg ** Concerta methylphenidate 18 mg mg Daytrana methylphenidate 10 mg 30 mg (transdermal) Dexedrine dextroamphetamine 5 mg 40 mg Focalin dexmethylphenidate 5 mg 40 mg Focalin XR Intuniv dexmethylphenidate guanfacine LA 10 mg 40 mg 1mg 4mg Metadate CD methylphenidate 20 mg 60 mg Methylin methylphenidate 10 mg 60 mg Ritalin methylphenidate 5 mg 50 mg Ritalin LA methylphenidate 20 mg 40 mg Strattera atomoxetine 60 mg 120 mg Tenex guanfacine 0.25 mg mg *** Vyvanse lisdexamfetamine 30 mg 70 mg Wellbutrin SR, LA bupropion 150 mg 300 mg * Suggested adult dose, ** Dosed 2 to 4 times daily, *** Dosed 2 to 3 times daily. Note: Dosage ranges may vary depending on source, and may also vary according to age. 11

12 Vyvanse(lisdexamfetamine) Pro-drug of dextroamphetamine Rapidly absorbed from GI tract and converted to dextroamphetamine and l-lysine 8 hour symptom coverage 30mg, 50mg, 70mg preparations Intuniv(guanfacine LA) FDA approved for treatment of ADHD in those ages 6-17 Available in 1 mg, 2mg, 3mg, 4mg tablets; dosed once daily FDA approved in September, 2009 Joe Wegmann, PD, LCSW 12

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