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Shire Reports Positive Signal Finding Study of Investigative Use of Vyvanse(R) (lisdexamfetamine dimesylate) Capsules as Adjunctive Treatment in Major Depressive Disorder
Date:10/29/2010

aucoma, agitated states, a history of drug abuse, taken an anti-depression medicine called a monoamine oxidase inhibitor (MAOI) within the last 14 days, or sensitivity to, are allergic to, or had a reaction to other stimulant medicines.

- Vyvanse is a stimulant medicine. The following have been reported with use of stimulants.

Heart-related problems:

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.

Mental (Psychiatric) problems:

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Vyvanse, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

- Serious side effects have been reported with use of stimulant medicines such as Vyvanse, including: - seizures, mainly in patients with a history of seizures - eyesight changes or blurred vision - motion and verbal tics. Patients with tics or Tourette's syndrome may experience a worsening of symptoms while taking Vyvanse. - slowing of growth. Your child should have his or her height and weight checked often while taking Vyvanse. The doctor may stop treatment if a problem is found during these check-ups. - The most common side effects reported in studies of Vyvanse were: - upper belly pain - nausea - dry mouth - dizziness - weight loss - trouble sleeping - irritability - decreased appetite - vomiting

For additional safety information, please see Full Prescribing Information (http://pi.shirecontent.com/PI/PDFs/Vyva
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SOURCE Shire plc
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