Focalin (dexmethylphenidate) is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy (Focalin Medication Guide). A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and were present before age 7 years. The symptoms must cause clinically significant impairment in social, occupational or academic functioning. Dexmethylphenidate is used as a treatment for ADHD, usually along with psychological, educational, behavioral or other forms of treatment.
Focalin is a central nervous system (CNS) stimulant. Its therapeutic effects is achieved by blocking the reuptake norepinephrine and dopamine into the pre-synaptic neuron and increase the release of these monoamines into the extra-neuronal space. The mode of therapeutic action in ADHD is unknown.
Focalin is contraindicated in patients with tension or agitation, since it may exacerbate these symptoms. Additionally, it is contraindicated in patients with a family history or diagnosis of Tourette’s syndrome or with motor tics. Focalin is also contraindicated during treatment with monoamine oxidase inhibitors (MAOIs), as hypertensive crises may result.
- Sudden Death and Preexisting Structural Cardiac Abnormalities or Other Serious Heart Problems - The U.S. Food and Drug Administration issued a warning in a February 2011 Drug Safety Communication that simulant products for ADHD should be avoided in patients diagnosed with serious heart problems, or for whom an increase in blood pressure or heart rate would be problematic, and advised that patients receiving ADHD medications should be periodically monitored for changes in heart rate or blood pressure. There was below the threshold of clinical concern for QT interval prolongation in a normal population
- Psychiatric Adverse Events - Preexisting Psychosis Administration of CNS stimulants in patients with a preexisting psychotic disorder may exacerbate symptoms of behavior disturbance and thought disorder. In particular, care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder, as a mixed or manic episode in such patients can result from CNS stimulant use. Additionally, treatment emergent manic or psychotic symptoms in adolescents or children without a prior history of mania or psychotic illness can be caused by stimulants at usual doses. Aggression and hostility have often been observed in children and adolescents with ADHD. While there is no systematic proof that stimulant medications cause aggressive behavior or hostility, patients starting pharmacotherapy ADHD should nevertheless be monitored for behavioral changes.
- Long-Term Suppression of Growth - Data show that children receiving treatment with CNS stimulants experience slowing in growth rate with no evidence of growth rebound.
- Seizures - Stimulants may lower seizure threshold particularly in patients with prior history of seizures, in patients with prior EEG abnormalities.
- Priapism - Prolonged and painful erections, sometimes requiring emergency treatment including surgical intervention, have been reported with methylphenidate products in both adult and pediatric patients.
- Peripheral Vasculopathy - Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. These are generally mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown.
- Visual Disturbance - Difficulties with accommodation and vision blurring have been reported with stimulant pharmacotherapy.
Addiction and Dependence
Focalin, like all CNS stimulants, carries a high potential for addiction and abuse and thus should be used cautiously in patients with a history of drug dependence or alcoholism. Chronic, abusive use can result in marked tolerance and psychological dependence with varying degrees of abnormal behavior.
Methylphenidate is generally well tolerated. Nervousness and insomnia are the most frequently reported adverse reactions. In children, abdominal pain, loss of appetite, weight loss, insomnia, and tachycardia may occur more frequently. Adverse Events occurring at an Incidence of 5% or More Among Focalin-Treated Patients, both in the adult and pediatric population, include:
- Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis
- Adverse Events with Other Methylphenidate HCl Products
- Musculoskeletal: rhabdomyolysis
Other adverse reactions include:
- Gastrointestinal: nausea
- Cardiac: angina, arrhythmia, palpitations, pulse increased or decreased, tachycardia
- Immune: hypersensitivity reactions including erythema multiforme with histopathological findings of necrotizing vasculitis, skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, and thrombocytopenic purpura
- Nervous System: dyskinesia, headache, dizziness, drowsiness, Tourette’s syndrome (rare), serotonin syndrome in combination with serotonergic drugs, toxic psychosis
- Vascular: blood pressure increased or decreased, cerebral arteritis and/or occlusion
Although a causal relationship has not been definitely established, the following adverse effects have been reported in patients taking Focalin/methylphenidate:
- Hepatobiliary: abnormal liver function, including severe hepatic injury
- Psychiatric: transient depressed mood, aggressive behavior
- Skin/subcutaneous: scalp hair loss
- Blood/lymphatic: leukopenia and/or anemia
- Urogenital System: priapism
- Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS
Genetic Testing for Focalin
MD Labs' pharmacogenetics program helps health care professional more effectively personalize treatment by identifying patients who may benefit from an alternative drug or dose. Read more about genetic testing for Focalin side effects with MD Labs' pharmacogenetic testing program.