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adverse reactions
ADVERSE REACTIONS The premarketing development program for methylphenidate capsules (CD) included exposures in a total of 228 participants in clinical trials (188 pediatric patients with ADHD, 40 healthy adult subjects). These participants received methylphenidate capsules (CD) 20 mg/day, 40 mg/day, and/or 60 mg/day. The 188 patients (ages 6 to 15) were evaluated in one controlled clinical study, one controlled, crossover clinical study, and one uncontrolled clinical study. Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs. Adverse events 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 events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse events. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Adverse Findings in Clinical Trials With Methylphenidate Capsules (CD) Adverse Events Associated With Discontinuation of Treatment In the 3 week placebo-controlled, parallel-group trial, two methylphenidate capsule (CD)-treated patients (1%) and no placebo-treated patients discontinued due to an adverse event (rash and pruritus; and headache, abdominal pain, and dizziness, respectively). Adverse Events Occurring at an Incidence of 5% or More Among Methylphenidate Capsule (CD)-Treated Patients TABLE 1 enumerates, for a pool of the three studies in pediatric patients with ADHD, at methylphenidate capsule (CD) doses of 20 mg/day, 40 mg/day, or 60 mg/day, the incidence of treatment-emergent adverse events. One study was a 3 week placebo-controlled, parallel-group trial, one study was a controlled, crossover trial, and the third study was an open titration trial. The table includes only those events that occurred in 5% or more of patients treated with methylphenidate capsules (CD) where the incidence in patients treated with methylphenidate capsules (CD) was greater than the incidence in placebo-treated patients. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events 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 treatments, 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 event incidence rate in the population studied. TABLE 1: Incidence of Treatment-Emergent Events Events, regardless of causality, for which the incidence for patients treated with methylphenidate capsules (CD) was at least 5% and greater than the incidence among placebo-treated patients. Incidence has been rounded to the nearest whole number. in a Pool of 3 to 4 Week Clinical Trials of Methylphenidate Capsules (CD) Body System Preferred Term Methylphenidate Capsules (CD) (n = 188) Placebo (n = 190) General Headache 12% 8% Abdominal pain (stomach ache) 7% 4% Digestive System Anorexia (loss of appetite) 9% 2% Nervous System Insomnia 5% 2% Adverse Events With Other Marketed Methylphenidate HCl Products Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy. There have been rare reports of Tourette’s Syndrome and obsessive-compulsive disorder. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to hepatic coma; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; a few instances of scalp hair loss. Very rare reports of neuroleptic malignant syndrome (NMS) have been reported, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur. Postmarketing Experience In addition to the adverse events listed above, the following have been reported in patients receiving methylphenidate capsules (CD) worldwide. The list is alphabetized: abnormal behavior, aggression, anxiety, bruxism, cardiac arrest, depression, fixed drug eruption, hyperactivity, irritability, libido changes, migraine, obsessive-compulsive disorder, peripheral coldness, Raynaud’s phenomenon, reversible ischaemic neurological deficit, rhabdomyolysis, sudden death, suicidal behavior (including completed suicide), and thrombocytopenia. Data are insufficient to support an estimation of incidence or establish causation.