Are you a binge eater who’s looking for a way to control your binge-eating ways? The Food and Drug Administration has approved a drug, Vyvanse (lisdexamfetamine dimesylate), that could help you.
The drug was originally marketed to treat attention deficit hyperactivity disorder (ADHD) among adults and children (at least 6 years old), but new studies have determined that it is also an effective treatment for binge-eating in adults.
From the FDA media release:
The efficacy of Vyvanse in treating binge-eating disorder was shown in two clinical studies that included 724 adults with moderate-to-severe binge-eating disorder. In the studies, participants taking Vyvanse experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviors compared to those on the inactive pill (placebo).
Want more technical details? This one’s from the media release of the drug’s manufacturer, shire.com:
The efficacy of Vyvanse in the treatment of B.E.D. was demonstrated in two 12-week randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies in adults aged 18 to 55 years (Study 1: N=374, Study 2: N=350) with protocol-defined moderate to severe B.E.D. (severity was defined as having at least 3 binge days per week for 2 weeks prior to the baseline visit and a Clinical Global Impression Severity score of ≥4 at baseline). The primary efficacy outcome for the two studies was defined as the change from baseline at week 12 in the number of binge days per week. Baseline is defined as the weekly average of the number of binge days per week for the 14 days prior to the baseline visit.
Subjects from both studies on Vyvanse had a statistically significant greater reduction from baseline in mean number of binge days per week at Week 12. In study 1, Vyvanse reduced the mean number of binge days per week from 4.79 at baseline to 0.78 at study endpoint compared with 4.60 to 2.22 for placebo. The least squares mean change from baseline in binge days per week was –3.87 and –2.51 for Vyvanse and placebo, respectively. Similar results were seen in study 2.
Can Vyvanse be used for weight loss? Weight loss is a metabolic side effect of the drug but Vyvanse should not be used for weight loss. At least until future studies show that it is safe to do so. In the words of the FDA, Vyvanse is “not approved for, or recommended for, weight loss. Its efficacy for weight loss has not been studied.”
The drug maker echoes the FDA’s cautionary warning with the following statement: “Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.”
It also said this: “Vyvanse is not indicated or recommended for weight loss or the treatment of obesity. Other sympathomimetic drugs used for weight loss have been associated with serious cardiovascular reactions.”
Since our website is mainly about side effects, we won’t be doing our job if we don’t tell you more about Vyvanse Binge Eating Disorder Drug Side Effects.
Well, check out this VYVANSE IMPORTANT SAFETY INFORMATION from vyvanse.com:
I. Tell the doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.
II. 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:
1. 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.
2. 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.
3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:
- Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red
- Call your doctor right away if you have any of these signs or symptoms or develop unexplained wounds on fingers or toes while taking Vyvanse.
III. The Most Common Side Effects of Vyvanse reported in studies of adults with moderate to severe B.E.D. were:
- dry mouth
- trouble sleeping
- decreased appetite
- increased heart rate
- feeling jittery