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FDA Approves Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents
Date:11/15/2010

ages 6 to 17 and adults. Vyvanse should be used as part of a total treatment program that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATIONVyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law. Vyvanse is a stimulant medication.  Misuse of stimulants may cause sudden death and serious cardiovascular adverse events.

  • Vyvanse should not be taken by patients who have:

  • Heart disease or hardening of the arteries,  moderate to severe high blood pressure,  overactive thyroid gland (hyperthyroidism),  glaucoma, 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 stimulant medicines.

  • 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
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