The Federal Drug Administration (FDA) recently released information on the side-effects of Concerta. The list is not new. It’s actually existed for many years. The problem is that it’s only part of the whole story. Here’s the rest of the story.

First, they don’t tell you that the FDA’s policy is to inform the public of any and every side effect that has ever occurred with a particular drug.  This means that even if only one of all the people tested had a particular reaction they will report it. 

Second, they don’t tell you that they will report a reaction ("side effect") despite the fact that the person had that reaction partly or wholly as a result of some other factor (something having nothing to do with the medication under scrutiny). So, it appears that the "side effect" is directly due to the medication, when this may not be true at all.

Third, the only place that the actual degree of risk (percentage of occurrence in those tested) of a particular side effect is listed is in the "Physician’s Desk Reference (PDR); and, even there they do not give a complete list. 

Fourth, there is information that seems only available to clinicians. 

There have been many studies conducted over the past 20 years regarding the issue of addiction to, abuse of, and dependence on medications like Concerta.  All these studies show the same finding:  people with ADD/ADHD do not become addicted to, do not abuse (the majority), and do not develop any dependency on ADD/ADHD medications.  In fact, proper treatment of ADD/ADHD actually reduces the risk that ADD/ADHD people will abuse drugs or alcohol.

Regarding the cardio-vascular effects of Concerta – There was a recent review of all the data gathered to-date regarding this issue.  The conclusion was that Concerta and medications like it do not raise the risk of cardio-vascular incidents.  In my experience, I have mostly seen patient’s whose blood-pressure was lowered by Concerta as a result of lowering their overall stress, depression, and improving their sleep!

Regarding the issue of Concerta possibly causing severe mental illness – The "real" issue here is improper use of Concerta.  If Concerta is given to someone with Bipolar Disorder or some psychotic disorder (like Schizophrenia), it can worsen their condition.  It will not "cause" either condition, just worsen it.  Unfortunately, events like this have occurred, but, again, they have happened not because of Concerta, but because some clinician mis-diagnosed the patient. 

Regarding the issue of Concerta’s possible effect on the GI system – The only GI effect caused by Concerta is mild stomach distress, usually resulting from taking it on an empty stomach, and, usually only in the first week when starting. 

Regarding the other listed side effects –

Seizures – In my experience I have never seen this, nor have I ever heard of this occurring.

Eye-sight blurring/changes – I have never seen this nor heard of this occurring.  However, Concerta can cause eye dryness in a small number of people.

Blockage of esophagus, small or large intestine – I have never seen this nor heard of it occurring.

Headache – This is rare.  If it happens it is usually only within the first week.  Considered an "acclimation" effect.

Stomachache – A rare occurrence.  Usually only in first week.  Problematic only in those with a history of having stomachaches in response to many substances.

Trouble sleeping – Only if taken too late in the day.  Concerta is meant to be taken in the morning.

Nervousness – Only if taken in too high a dose.

Dizziness – Only if taken in too high a dose.

The "real" problem to me as a Specialist in this area are the physicians (family practitioners, physician assistants, nurse practitioners, internists, and other non-psychiatrist clinicians) most of whom know very little about ADD/ADHD and about the medications used to treat it.  Yet, they are the one’s who do most of the "diagnosing" of ADD/ADHD and dispensing of the medications in our country.  They tend to diagnose quickly (sometimes within 15 minutes) or only partially diagnose (miss conditions that frequent co-occur with ADD/ADHD). Then they prescribe medication and more often than not do very little education with the patient (regarding the medication), and, almost no monitoring (ADD/ADHD medications should be monitored very closely in the first few weeks).  I can give you a recent example – 15y/o boy; nurse practitioner gave him a dose based on his body-weight; he had several negative reactions, e.g., dizziness; NP determined dose by the mg/kg method (all psychotropic medications are dosed according to the "dose-response" method).

Michael G. Gingerich, LCSW, Ph.D.