FDA Warnings on Stimulants
Here is our position on the FDA warning regarding stimulant medications:
There is no new information on stimulant risks, although the media is presenting it as such. The FDA has been examining potential risks of ADD medications for the last several years. FDA sub-committees of physicians (cardiologists, psychiatrists, pediatricians) have been meeting to determine what level of labeling should be added to stimulant medications since there have been cases of “sudden death” in patients taking stimulants. Those patients who died were found to have underlying cardiac problems, so the question was did the medication cause the underlying cardiac problem or was the cardiac problem a pre-existing condition? The FDA admits it “does not have good information” indicating whether ADHD drugs caused the cardiovascular events. In fact the risk of sudden death in the general population not taking stimulants is higher than the risk of sudden death in ADD patients taking a stimulant. Therefore the FDA concluded that stimulant medications may or may not have contributed to the cardiovascular problems.
This led to the decision by the FDA not to put a “black box warning” on stimulant medications. A black box warning would have been the most serious type warning on a medication package label. Instead the FDA followed the sub-committee recommendations to add notes within the regular text of stimulant medication package inserts on potential cardiovascular risks, and order distribution of medication guides to patients and their caregivers. The warnings on the drug inserts were added LAST YEAR, but it took the FDA until now to order completion of the medication guides. Drug manufactures now have 30 days to implement this additional step, which is why the media is re-presenting this same information.
Additionally, cardiovascular risk studies at Mass General in adult ADD patients taking stimulant medication failed to show any increase risk of cardiovascular problems with long term stimulant use. Patients were followed for two year. The data is not supporting that the medications are causative.
At ADD Health and Wellness centers, we obtain a comprehensive cardiac history from all of our patients, including a thorough family cardiac history to ensure safe assessment prior to use of the medications. ADD treatment guidelines do not recommend routine EKG’s before administering stimulant medications since the data has not shown EKG changes as a side effect.
Last 5 posts by Dr. Theresa Cerulli
- American Heart Association Recommends EKG's - April 27th, 2008
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- ADHD and Sleep - March 9th, 2008
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