Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) Becomes First and Only Treatment Approved by the FDA for Adults with Moderate to Severe Binge Eating Disorder - Seite 3

B.E.D. is the most common eating disorder in the United States, affecting an estimated 2.8 million adults, according to a national survey. B.E.D. occurs in both men and women, and is more common than anorexia and bulimia combined. B.E.D. can occur in normal weight,

overweight, and obese adults, and is seen across racial and ethnic groups. Medication is not appropriate for all adults with B.E.D.

More About Vyvanse (lisdexamfetamine dimesylate) B.E.D. Clinical Trials 

In the two 12-week studies, patients were confirmed with a diagnosis of B.E.D. using DSM-IV-TR^® criteria for B.E.D. For both studies, a binge day was defined as a day with at least 1 binge episode, as determined from the subject's daily binge diary and confirmed by the clinician.

About VYVANSE (lisdexamfetamine dimesylate) 

INDICATION 

Vyvanse is a prescription medicine for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults.

Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

IMPORTANT SAFETY INFORMATION 

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal. 

• Do not take Vyvanse if you: 
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI
  • are sensitive to, allergic to, or had a reaction to other stimulant medicines

• Some people have had the following problems when taking stimulant medicines, such as Vyvanse: 
  • Heart-related problems including:  
    • sudden death in people who have heart problems or heart defects 
    • sudden death, stroke and heart attack in adults 
    • increased blood pressure and heart rate 

Tell your doctor if you have any heart problems, heart defects, high blood pressure, or a family history of these problems. The doctor should check your blood pressure and heart rate regularly during treatment. Call your doctor right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.

• Mental (psychiatric) problems including: 
  • new or worse behavior and thought problems 
  • new or worse bipolar illness 
  • new psychotic symptoms such as:  
    • seeing things or hearing voices that are not real 
    • believing things that are not true 
    • being suspicious 
  • new manic symptoms 

Tell your doctor about any drug abuse, alcohol abuse or mental problems that you have had, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you have any new or worsening mental symptoms or problems while taking Vyvanse.