Clinical Summary of Pediatric Metabolic AERS Reports. Judith Cope, MD, MPH Office of Pediatric Therapeutics/FDA

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1 Clinical Summary of Pediatric Metabolic AERS Reports Judith Cope, MD, MPH Office of Pediatric Therapeutics/FDA 1

2 Clinical Summary of Pediatric Metabolic AERS Reports: Atypical Antipsychotics n=100 reports; 9/1/08-8/31/09 Pediatric Review for 5 atypical antipsychotics Seroquel (quetiapine): Abilify (aripiprazole): Risperdal (risperidone); Zyprexa (olanzapine) and Geodon (ziprasidone) Serious & Non-serious AERS reports (note: this encompasses all events) Pediatric age 17 years 2

3 Normal Physical Growth for 2-20 Years of Age height height weight Males weight Females Height and Weight Gain Each Year Childhood: males & females 2-3 inches; 5-6 lbs Adolescence: males inches; lbs females inches; lbs 3

4 Summary 9/1/2008-8/31/09 Pediatric Serious & Non-serious Metabolic AEs n=100 Deaths=6 Hospitalizations=13 Concomitant Medications (42 of 100 reports) 4

5 Points to Consider in the Review of Metabolic Events Concomitant medications Many patients had multiple psychiatric disorders Many of the most severe cases were reports submitted by personal injury attorneys Limitations in identification and definition Symptoms frequently subtle & develop over long time period Definition of serious weight gain may vary by age Definition of serious glucose elevation may also vary Increase in cholesterol/triglyceride may be asymptomatic 5

6 Total Number of Prescriptions Dispensed for Atypical Antipsychotic Agents in the Pediatric Population (Ages 0-17 Years) from U.S. Outpatient Retail Pharmacies, Years Source: SDI: Vector One: National. Data Extracted TRx (millions) risperidone aripiprazole quetiapine ziprasidone olanzapine paliperidone The greatest increase for aripiprazole at 96% Year 6

7 Pediatric Metabolic AERS Reports: Serious and Non-serious Reports, Ages 6-17 years; 9/1/08-8/31/09 Seroquel n=48 reports 5 Deaths (complex clinical history) 13 Weight gain specifically mentioned 36 Diabetes: child developed, experienced or had Other: 1 Gastric bypass surgery Concomitant medications mentioned in 28 of 48 reports *Note: Patient may have more than one AE 7

8 Pediatric Metabolic AERS Reports: Serious and Non-serious Reports, Ages 6-17 years; 9/1/08-8/31/09 Abilify n=33 reports 5 Hospitalized (2 for hyperglycemia; one had blood glucose >600 mg/dl and diabetes) 22 Weight gain specifically mentioned 3 Developed diabetes 8 others (e.g., hypertriglyceridemia) Concomitant medications mentioned 2 of 33 reports *Note: Patient may have more than one AE 8

9 Pediatric Metabolic AERS Reports: Serious and Non-serious Reports, Ages 6-17 years; 9/1/08-8/31/09 Risperdal n=11 reports 3 Hospitalized (behavioral & high glucose) 4 Weight gain specifically mentioned 7 Diabetes: child developed/experienced or had Concomitant medications mentioned 5 of 11 reports *Note: Patient may have more than one AE 9

10 Zyprexa n=7 reports 1 Death Pediatric Metabolic AERS Reports: Serious & Nonserious Reports, Ages years; 9/1/08-8/31/09 4 Hospitalized 3 Diabetes: child developed/experienced or had 1 Weight gain specifically mentioned Other: 1 each with pancreatitis, hyperprolactinemia Concomitant medications mentioned 6 of 7 *Note: Patient may have more than one AE 10

11 Pediatric Metabolic AERS Reports: Serious and Non-serious Report, Age 13 years; 9/1/08-8/31/09 Geodon n=1 report Hospitalized Patient reported to have diabetes, high cholesterol, triglyceride and hospitalized for injurious behavior/suicidal ideation Concomitant medication mentioned *Note: Patient may have more than one AE 11

12 Case Examples of Excess Weight Gain - AERS Seroquel 8 yo m: Family reported 4-5 lbs in 1 month. lethargy 16 yo f: Hospitalized. 15 lb in 1 month after starting Seroquel. Abilify 6 yo m: 40 lbs in 6 mos (6.6 lb/mo). Dr. says liver disease 2 to wt gain. 15 yo f: 13 lbs in 1-2 mos (6.5lb/mo). Ankle edema, tremor, BP. Risperdal 7 yo m: 12 lbs in 1 month. On stimulant medications for ADD and ODD yo f: 65 lbs weight gain. On risperidone for 1 year for anxiety. Zyprexa 13 yo f: 81 lbs in 4 mos (went from 89 to 170 lbs) 1 ODD oppositional defiance disorder 12

13 Limitations to the Adverse Event Reporting System (AERS) FDA does not receive all adverse event reports that occur with a product. Time on the market and publicity surrounding a particular adverse event can influence the reporting of the event. Reports do not always contain enough detail to properly evaluate an event. There is no certainty that the reported event was actually due to the product. Spontaneous reports cannot be used to calculate the absolute incidence of an adverse event or be used to measure quantifiable differences in known risk among products. 13

14 In Summary. Clinical data from the hands-on review of pediatric serious & non-serious metabolic events from the FDA AERS database over the past year provided examples of extreme weight gain, onset of diabetes and additional support for the need of longer-term comparative study data in the child and adolescent age groups. 14

15 Acknowledgements Co-Reviewer Suzanne Malli, BA, BSN OPT Additional Input, Review & Recommendations by Office of Pediatric Therapeutics Office of Surveillance & Epidemiology Pediatric Maternal Health Staff Division of Psychiatric Products Office of Science Health Coordination 15

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