Summary of the FDA Report February 9, 2006
The FDA had an advisory panel which was going to review how to study the safety of ADHD medications. Instead, the committee came back with a surprising vote, recommending that the FDA provide a black box warning on the stimulant medications, out of concern for cardiac risks.
The stimulant medicines include: Ritalin, Concerta, Metadate, Methylin, Adderall, and Adderall XR.
ADHD is a significant disorder which affects approximatly 5-7% of children, and 4% of American adults.
Please listen to the audio special report for a full review of this issue - and the implications of the suggestion today.
Take home messages:
1) Safety comes first: Of course, no one wants medicine prescribed if it is going to harm. The issue is that there are insufficient data at this time to say that ADHD medications cause cardiac risks. We need the complete studies to be done to understand the risks.
2) Please do not stop an ADHD medicine abruptly: If you or someone you care about is taking an ADHD medication, and there are no side effects or concerns - do not stop the medication abruptly just because of this report. Please speak to your doctor.
3) Cardiac concerns: If there is any history of cardiac concerns and you are taking ADHD medication, please see your doctor to review the safety and see if an alternative medication may be necessary.
4) If you are now considering medication for ADHD: Please review the options fully. Having ADHD untreated leads to significant risks. The medications have side effects, however the risks are low and the benefit can be significant. Please review the use of medication in the context of a comprehensive treatment plan - including behavioral, psychological and academic treatments.
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