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adverse reactions
6 ADVERSE REACTIONS Children ages 6 to 12: Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) were decreased appetite, dizziness, dry mouth, irritability, insomnia, upper abdominal pain, nausea, vomiting, and decreased weight. ( 6.1 ) Adolescents ages 13 to 17: Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) were decreased appetite, insomnia, and decreased weight. ( 6.1 ) Adults: Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) were upper abdominal pain, diarrhea, nausea, fatigue, feeling jittery, irritability, anorexia, decreased appetite, headaches, anxiety, and insomnia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience The premarketing development program for Vyvanse included exposures in a total of 995 participants in clinical trials (348 pediatric patients aged 6 to 12 years, 233 adolescent patients aged 13 to 17 years, 358 adult patients and 56 healthy adult subjects). Of these, 348 pediatric (aged 6 to 12) patients were evaluated in two controlled clinical studies (one parallel-group and one crossover), one open-label extension study, and one single-dose clinical pharmacology study, 233 adolescent (aged 13 to 17) patients were evaluated in one controlled clinical study, and 358 adult patients were evaluated in one controlled clinical study and one open-label extension study. The information included in this section is based on data from the 4-week parallel-group controlled clinical studies in pediatric and adult patients with ADHD. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs. Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized reactions categories. In the tables and listings that follow, MedDRA terminology has been used to classify reported adverse reactions. The stated frequencies of adverse reactions represent the proportion of individuals who experienced a treatment-emergent adverse reaction of the type listed at least once. Adverse Reactions Associated with Discontinuation of Treatment in Clinical Trials In the controlled pediatric (aged 6 to 12) trial, 9% (20/218) of Vyvanse-treated patients discontinued due to adverse reactions compared to 1% (1/72) who received placebo. The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, and rash (2/218 each; 1%). In the controlled adolescent (aged 13 to 17) trial, 4% (10/233) of Vyvanse-treated patients discontinued due to adverse events compared to 1% (1/77) who received placebo. The most frequent adverse reactions leading to discontinuation and considered to be drug-related were irritability (3/233; 1%), decreased appetite (2/233; 1%), and insomnia (2/233; 1%). In the controlled adult trial, 6% (21/358) of Vyvanse-treated patients discontinued due to adverse events compared to 2% (1/62) who received placebo. The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that of placebo) were insomnia (8/358; 2%), tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358; 1%), anxiety (2/358; 1%), and dyspnea (3/358; 1%). Adverse Reactions Occurring at an Incidence of 2% or More Among Vyvanse Treated Patients in Clinical Trials Adverse reactions reported in the controlled trials in pediatric (aged 6 to 17 years) and adult patients treated with Vyvanse or placebo are presented in Tables 1, 2, and 3 below. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse reactions in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatment uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse reaction incidence rate in the population studied. Pediatric Table 1 Adverse Reactions Reported by 2% or More of Children (Aged 6 to 12 Years) Taking Vyvanse in a 4-Week Clinical Trial Body System Preferred Term Vyvanse (n=218) Placebo (n=72) Gastrointestinal Disorders Abdominal Pain Upper 12% 6% Vomiting 9% 4% Nausea 6% 3% Dry Mouth 5% 0% General Disorder and Administration Site Conditions Pyrexia 2% 1% Investigations Weight Decreased 9% 1% Metabolism and Nutrition Decreased Appetite 39% 4% Nervous System Disorders Dizziness 5% 0% Somnolence 2% 1% Psychiatric Disorders Insomnia a 23% 3% Irritability 10% 0% Affect lability 3% 0% Tic 2% 0% Skin and Subcutaneous Tissue Disorders Rash 3% 0% a Insomnia includes the following preferred terms reported in the study: Initial Insomnia, Insomnia. Note: This table includes those reactions for which the incidence in patients taking Vyvanse is at least twice the incidence in patients taking placebo. Table 2 Adverse Reactions Reported by 2% or More of Adolescent (Aged 13 to 17 Years) Patients Taking Vyvanse in a 4-Week Clinical Trial Body System Preferred Term Vyvanse (n=233) Placebo (n=77) b Insomnia includes the following preferred terms reported in the study: Initial Insomnia, Insomnia. Note: This table includes those reactions for which the incidence in patients taking Vyvanse is at least twice the incidence in patients taking placebo. Gastrointestinal Disorders Dry Mouth 4% 1% Investigations Weight Decreased 9% 0% Metabolism and Nutrition Decreased Appetite 34% 3% Psychiatric Disorders Insomnia b 13% 4% Adult Table 3 Adverse Reactions Reported by 2% or More of Adult Patients Taking Vyvanse in a 4-Week Clinical Trial Body System Preferred Term Vyvanse (n=358) Placebo (n=62) Gastrointestinal Disorders Dry Mouth 26% 3% Diarrhea 7% 0% Nausea 7% 0% General Disorder and Administration Site Conditions Feeling Jittery 4% 0% Investigations Blood Pressure Increased 3% 0% Heart Rate Increased 2% 0% Metabolism and Nutrition Disorders Decreased Appetite 27% 3% Anorexia 5% 0% Nervous System Disorders Tremor 2% 0% Psychiatric Disorders Insomnia c 27% 8% Anxiety 6% 0% Agitation 3% 0% Restlessness 3% 0% Respiratory, Thoracic, and Mediastinal Disorders Dyspnea 2% 0% Skin and Subcutaneous Tissue Disorders Hyperhidrosis 3% 0% c Insomnia includes the following preferred terms reported in the study: Initial Insomnia, Insomnia, Middle Insomnia. Note: This table includes those events for which the incidence in patients taking Vyvanse is at least twice the incidence in patients taking placebo. In addition, adverse reactions observed at a rate of less than 2% included decreased libido and erectile dysfunction. Vital Signs Weight Loss - In the controlled adult trial, mean weight loss after 4 weeks of therapy was 2.8 lbs, 3.1 lbs, and 4.3 lbs, for patients receiving final doses of 30 mg, 50 mg, and 70 mg of Vyvanse, respectively, compared to a mean weight gain of 0.5 lbs for patients receiving placebo. 6.2 Postmarketing Reports The following adverse reactions have been identified during post approval use of Vyvanse. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders - Palpitation Eye Disorders - Vision blurred, mydriasis, diplopia General Disorders and Administration Site Conditions - Fatigue Hepatobiliary Disorders - Eosinophilic Hepatitis Immune System Disorders - Anaphylactic reaction, hypersensitivity Nervous System Disorders - Somnolence, seizure, dyskinesia Psychiatric Disorder - Psychotic episodes, mania, hallucination, depression, aggression, dysphoria, euphoria, logorrhoea, dermatillomania Skin and Subcutaneous Tissue Disorder - Stevens-Johnson Syndrome, angioedema, urticaria 6.3 Adverse Reactions Associated with the Use of Amphetamine Cardiovascular Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses, overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, depression, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome, seizures, stroke. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Allergic Urticaria, rashes, and hypersensitivity reactions, including angioedema and anaphylaxis. Serious skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been reported. Endocrine Impotence, changes in libido.