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FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD
Date:6/1/2009

Vyvanse should not be taken if you or your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.

Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought 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 the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.

Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.

Talk to your health care provider if your child experiences slowing of growth (height and weight). Children should have their height and weight checked periodically while taking Vyvanse. Your healthcare provider may stop Vyvanse treatment if a problem is found during these check-ups.

Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth.

Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics,
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SOURCE Shire plc
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