The U.S. Food and Drug Administration announced Friday that the approved uses for Vyvanse (lisdexamfetamine dimesylate) has been expanded to include treatment for binge-eating disorder, making Shire's ADHD pill the first to be approved by the agency for treating the eating disorder.
Vyvanse was first approved for use in 2007 as a once-a-day drug for treating attention deficit hyperactivity disorder in patients six years old and older. It was assessed under the priority review program of the FDA after it was shown in two studies to lead to a drop in binge-eating instances.
"Binge eating can cause serious health problems and difficulties with work, home, and social life. The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating," said Mitchell Mathis, M.D., Division of Psychiatry Products director from the Center for Drug Evaluation and Research at the FDA.
Vyvanse will include a medication guide to inform patients about the proper use of the drug as well as the risks accompanying its use.
Some of the most serious health risks associated with Vyvanse are heart complications, which can lead to sudden death in those with heart defects or problems. Psychiatric problems have also been reported as possible side effects of using the stimulant, leading to manic or psychotic symptoms like mania, delusional thinking or hallucinations, even when a patient does not have a history of psychotic illness.
Other side effects reported in the studies include anxiety, constipation, jittery feelings, increased heart rate, sleeplessness (insomnia) and dry mouth.
Binge-eating disorder prompts an individual to compulsively overeat, leading them to consume larger than usual amounts of food. After doing so, they are filled with guilt and shame, resulting in social isolation.
As the disorder causes too much food to be consumed, weight gain and obesity-related health problems are common in those who binge-eat. Taking Vyvanse lessens the number of binge-eating episodes in a week, which will naturally lead to weight loss. However, the medication is not recommended directly as a weight loss supplement and must not be taken outside its prescribed use.
More severe than the usual overeating that afflicts many Americans, binge-eating disorder affects about 5 million women and 3 million men in the United States. It is also an "equal opportunity" disorder, affecting men and women regardless of race. Binge-eating disorder is different from bulimia nervosa in that patients suffering from the former do not purge.