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Shire Reports Tolerability and Clinical Effects Results of Daytrana(R) (methylphenidate transdermal system) from Study in Adolescents with ADHD
Date:10/30/2009

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All treatment-emergent adverse events were of mild to moderate intensity and none led to discontinuation from the study. No deaths or serious adverse events were reported. Eighteen children reported at least one treatment-emergent adverse event, and the most frequently reported was decreased appetite (27.3 percent of participants receiving OROS MPH and 8.3 percent of participants receiving both escalating doses and multiple fixed doses of Daytrana). Nineteen adolescents reported at least one treatment-emergent adverse event, and the most frequently reported was headache (27.3 percent of participants receiving OROS MPH and 16.7 percent of participants receiving escalating doses of Daytrana, and none of the participants receiving multiple fixed doses of Daytrana).

This study was not designed to make comparisons between Daytrana and OROS MPH.

Important Safety Information about Daytrana

Daytrana is indicated for the treatment of ADHD in children aged 6 to 12 years.

Daytrana should not be used in patients with allergy to methylphenidate or patch components; marked anxiety, tension and agitation; glaucoma; tics, diagnosis or a family history of Tourette's syndrome; seizures; or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs).

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Physicians should take a careful patient history, including family history, and physical exam to assess the presence of cardiac disease. Patients who report symptoms of cardiac disease such as exertional chest pain and unexplained syncope should be promptly evaluated. Use with caution in patients whose underlying medical condition migh
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SOURCE Shire plc
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