Black box warning on ADHD medications (?)

F

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.
 
F

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
RITALIN LA®.
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
problems
• new or worse bipolar illness
• new or worse aggressive behavior or
hostility
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
suspicious.
 

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:
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS
CARDIOVASCULAR ADVERSE EVENTS.
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.
 
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