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Shire Developed DAYTRANA – The First Medication to Treat ADHD Symptom

ores declined 56% (24.2 points) from baseline for children treated with DAYTRANA versus a decline of 24% (10.3 points) for those treated with placebo (P < .0001). ADHD-RS-IV assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision?, a publication of the American Psychiatric Association.

In both the phase II and phase III studies, DAYTRANA was generally well tolerated during both the dose optimization and double-blind phases. Adverse events typically were mild to moderate, resolved with continued therapy and were consistent with known effects of methylphenidate.

Important Safety Information

DAYTRANA was generally well tolerated in clinical studies. As with other products containing methylphenidate (the active ingredient in DAYTRANA), common side effects reported with DAYTRANA were decreased appetite, insomnia, nausea, vomiting, weight loss, tics, and affect lability (mood swings). Abuse of methylphenidate may lead to dependence.

Parents or caregivers should tell the child's physician about any heart conditions their child or family members may have. Also parents and caregivers should tell the doctor if their child has a history of high blood pressure, problems with alcohol or drugs, depression, bipolar disorder, abnormal thoughts/behaviors, visual disturbances, or seizures. Inform the doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting. Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Methylphenidate should not be taken by children with significant agitation; glaucoma; tics, family history or diagnosis of Tourette's syndrome; or current/recent use of MAO inhibitors (a type of antidepressant). DAYTRANA should not be used by children allergic to methylphenidate or other ingredients in DAYTRANA.

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