Black box warning on ADHD medications (?)

Discussion in 'General Parenting' started by flutterbee, Apr 12, 2008.

  1. flutterbee

    flutterbee Guest

    I saw a blip on Discovery Health at around 4am but can't find an article. Anyway it sounded like they were saying that the FDA is going to be adding a black box warning to ADHD medications for a couple of reasons, one of them being irritability and agitation (don't quote me exactly). Also said that the medications are overprescribed and should be used at the smallest possible dose for the shortest amount of time possible. I'll keep looking.
  2. flutterbee

    flutterbee Guest

    I found this - don't know how new it is:

    What is the most important information I
    should know about RITALIN LA®?
    The following have been reported with use of
    methylphenidate hydrochloride and other
    stimulant medicines.
    1. Heart-related problems:
    • sudden death in patients who have heart
    problems or heart defects
    • stroke and heart attack in adults
    • increased blood pressure and heart rate
    Tell your doctor if you or your child have any heart
    problems, heart defects, high blood pressure, or a
    family history of these problems.
    Your doctor should check you or your child
    carefully for heart problems before starting
    Your doctor should check your or your child’s
    blood pressure and heart rate regularly during
    treatment with RITALIN LA®.
    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 RITALIN LA®.
    2. Mental (Psychiatric) problems:
    All Patients
    • new or worse behavior and thought
    • new or worse bipolar illness
    • new or worse aggressive behavior or
    Children and Teenagers
    • new psychotic symptoms (such as hearing
    voices, believing things that are not true, are
    suspicious) or new manic symptoms
    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 RITALIN LA®, especially
    seeing or hearing things that are not real,
    believing things that are not real, or are
  3. Sara PA

    Sara PA New Member

    This Ritalin Medication Guide which you linked was last updated in April, 2007.

    Two years ago one committee at the FDA recommended the additional black box warning for aggression for stimulants but a second committee voted it down. It was related to cardiovascular risk. It was also considering a black box warnings for aggressive events and suicidal behavior but they weren't added either.

    All the amphetamine/amphetamine-like stims have a black box waring about potential for addiction. Adderall XR and Dexedrine carry an additional warning about cardiovascular events and sudden death. This is from Adderall XR:
    The prescribing informations for all the stims have always said that the drugs should be started at low dose and increased only if the low dose isn't effective and that doctors must periodically reevaluate need when the drug is taken over a long period of time. And they say that the doses should be lowered or, if necessary, discontinued of side effects occur.