Non-Safety-Related Voluntary Recall of a Limited Portion of DAYTRANA(TM) (Methylphenidate Transdermal System) Patches... (t heart problemssuch as chest pain or fa...)

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Non-Safety-Related Voluntary Recall of a Limited Portion of DAYTRANA(TM) (Methylphenidate Transdermal System) Patches Announced

Date:6/9/2008

t heart problems, such as chest pain or fainting.

Daytrana should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of Daytrana; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette's syndrome.

Tell your doctor before using Daytrana if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell your doctor immediately if the child develops any of these conditions/symptoms while using Daytrana.

In clinical studies, side effects were generally mild to moderate. The most common side effects reported with Daytrana were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics, and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Tell your doctor if the child has blurred vision while using Daytrana.

Abuse of Daytrana can lead to dependence.

Daytrana should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin redness or itching is common with Daytrana. Allergic skin rash may occur.

SHIRE LIMITED

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to
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Non-Safety-Related Voluntary Recall of a Limited Portion of DAYTRANA(TM) (Methylphenidate Transdermal System) Patches...(t heart problemssuch as chest pain or fa...)