New ADHD Drug VYVANSE Approved by FDA

February 27th, 2007

The recently approved a new amphetamine-based drug for hyperactivity disorder that will be harder to abuse than older stimulants, according to pharmaceutical company Shire. Vyvanse remains inactive until swallowed, after which it gradually releases its active ingredient d-amphetamine. It is activated after coming into contact with enzymes in the digestive tract.

Vyvase is expected to stop the potential for abuse by individuals who snort or inject crushed pills. The newly developed drug will be listed as a Schedule II drug, a category including cocaine, methadone, methamphetamines, and other ADHD medicines such as Adderall and Ritalin. Vyvanse will carry a “black-box” warning because of safety concerns related to amphetamine abuse, as well as the risk of sudden death in patients with heart defects.

The FDA approval of Vyvanse took place in the same week when the agency required manufacturers of other ADHD drugs to warn patients and parents of potential mental and heart problems associated with these medications in a small percentage of users.

FDA statistics indicate that ADHD affects about 3 to 7% of schoolchildren and 4% of adults. The principal symptoms are hyperactive behavior, difficulty paying attention, and problems with impulse control. Medications approved to treat ADHD have major benefits for many patients but for some, they can also pose serious risks.

New warning instructions required for ADHD medications will be included for Adderall, Concerta, Daytrana, Dexedrine, Focalin, Metadate, Methylin, Ritalin, and Strattera.  It is hoped these new cautionary guidelines will not keep people who need these drugs from taking them.

Sources:  Yahoo News; Medical News Today

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Entry Filed under: ADHD,ADHD,CHILDREN'S HEALTHCARE,Heart Conditions,PRESCRIPTION DRUGS

2 Comments Add your own

  • 1. Todd  |  September 24th, 2007 at 5:02 am

    Dr. Sears’ ADD & Nutrition

    My mother reads your blog routinely. I wanted to share this article with you. It’s very interesting. By bringing out the good points, a doctor explains how nutrition is all anyone ever needs to fight ADD.

    The doctor starts out by referring to Paris Hilton’s infamous run-in with a DUI felony. Paris has been on medication for ADD since she was a child and all of the drugs come with nasty side-effects. Dr. Sears directs patients to the “Modern Diet,” stating that nutrition works as an alternative solution.

    He makes a convincing argument. Can society really have been duped by the medical prescription field for so long?

    Check it out. http://www.alsearsmd.com/signup/ADHD/ADHDpress2.html

    I am anxious to hear your feedback. Thanks, -Todd

  • 2. Anna Dabney  |  September 24th, 2007 at 3:56 pm

    Dear Todd,
    I try to present an unbiased viewpoint and report on news on drugs, both positive and negative. I don’t believe that you can use a “one size fits all” approach to individual health problems. Some can be greatly helped by ADD-type medications, with benefits outweighing the risks that come with any prescription drug. For some, perhaps a change in diet would be helpful. It certainly isn’t the solution for everyone.

    As a parent of grown children and a former teacher, I can tell you that I am grateful my son and daughter never required these drugs. Many of these prescriptions were not available in the 1970s and early 1980s. They may well be overutilized today.

    In my opinion, smaller class sizes, behavior modification training, more actively involved parenting, and teachers with more challenging lesson plans could help to resolve the attention deficit disorders that some children exhibit early. Sometimes, it is the brightest, most creative children who become restless in class. Teachers who have 38 or more students in a class can be under great stress and may unduly refer “ADD” students to be considered for amphetamine-based drugs.

    The child’s physician would be wise to proceed cautiously, pursuing other avenues first before prescribing drugs that may be quite difficult to get off further down the road. Parents should not pressure their child’s physician to make their child more manageable through drug use before they have looked into other alternatives. When medications are definitely called for, ADHD type drugs have the potential to make positive changes in the ADD child, his family life, and the school classroom.

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