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FDA Approves ADHD Patch

April 10, 2006

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The Food and Drug Administration has approved Daytrana, the first skin patch for treating Attention Deficit Hyperactivity Disorder in children six to 12 years of age. Daytrana is a once-daily treatment containing the drug methylphenidate, a central nervous system stimulant.

ADHD is a condition that affects approximately three to seven percent of school-aged children. The three main symptoms of ADHD are inattention, hyperactivity, and impulsivity. Children with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

The manufacturer said Daytrana should be applied each morning to the alternating hip, and worn for nine hours. Parents and caregivers will be provided a chart to track the application and removal of the patch.

The FDA said the prescriber may change the amount of time the patch is worn to help manage how long the medication works each day and some of the side effects that may be caused by methylphenidate.

If the patch is worn for longer than the recommended nine hours, methylphenidate-induced side effects such as insomnia may occur with greater frequency in some children. Other possible side effects include blurred vision, mild skin irritation or an allergic skin rash and slower weight gain and height growth.

Stimulant products generally should not be used in children with known structural cardiac abnormalities because of a concern that stimulants may further increase the risk of sudden death above the risk that is already present with such abnormalities.

Daytrana should not be used if the child:

• Has significant anxiety, tension, or agitation, since methylphenidate may make these conditions worse.

• Has allergies to methylphenidate or other ingredients in Daytrana.

• Has glaucoma, an eye disease.

• Is currently taking a monoamine oxidase inhibitor (MAOI), a treatment for depression, or has discontinued a MAOI in the last 14 days.

• Has motion or verbal tics or Tourette's syndrome, or a family history of Tourette's syndrome.

The FDA said Daytrana has been shown to be safe and effective in two placebo controlled studies in children six to 12 years of age with ADHD. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures such as psychological, education and social, for patients with ADHD.

Daytrana is manufactured for Shire US. Inc., by Noven Pharmaceuticals Inc.

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