Stimulant Medications Increase Risk for Sudden Death in Children

Stimulant Medications Increase Risk for Sudden Death in Children

There has been quite a recent string of activity surrounding the recent publication in the American Journal of Psychiatry showing a 7 fold increase in the incidence of sudden death in children who are on stimulant medications (Concerta, Ritalin, Adderall, Focalin and Dexedrine).

Recently the FDA urged “caution” in interpreting this study due to parents “bias” in reporting the medications their children were on. The study screened parents by asking them what medications their children were on at time of death. The FDA Director Dr. Robert Temple, MD highly stressed that this screening is “subject to recall bias” and that these results should not serve as a basis for parents stop medication their children due to other “risk behavior associated with ADHD.”

The lead author, Dr. Madelyn Gould, PhD rebuts this argument and states that “This study had enough statistical power to detect an association. My confidence in the results is not diminished, since it has been peer-reviewed [and published].” Incidentally this study was funded by the FDA and the National Institute of Mental Health. Looks like maybe the results were not what they hoped for.

This controversy began when last year a study, similar to this one, found that stimulant medication exacerbated underlying heart abnormalities previously not detected – leading to fatal arrhythmias (abnormal heart beats).  After this study the American Heart Association (AHA) recommended that physicians order an ECG (to monitor the heart) if a child was to be put on stimulant medications – which is still their recommendations today. The American Association of Pediatrics (AAP) released their own statement saying ECGs are not warranted.

So who are we to believe? After two highly controlled studies dealing with the most severe side effect (DEATH) – it would seem that erring on the side of caution is warranted. I mean after all, an ECG is one of the most simple diagnostic testing that can be performed. But honestly – wouldn’t you think twice if your doctor said “Let’s put your child on Ritalin, but first we need to do an ECG to make sure his heart is strong because if not, it raises the risk of sudden death 6 times.” I guarantee most parents would run out of the door.

It doesn’t make any sense to me why the FDA seems to have the attitude of a drug being safe until proven otherwise – backward to me. At the same time, don’t they know that in August of 2008 the AAP admitted that they were wrong in denying the association of food preservatives and dyes with ADHD. Don’t they know multiple studies have shown that the omega-3 oil EPA out beats Ritalin in the Connors Scale (the standard test that rates severity of ADHD) with diarrhea being the most severe side effect? Oh let’s not forget about lasts year study showing pycnogenol (an antioxidant from the Pine Tree) again, outperformed Concerta with no side effects.  I could go on and on!

It makes more sense (then again maybe these guys are so lost in statistical numbers to think logically) to try the above measures FIRST – which have NO association and NO reported side effects that are life threatening at all. Our Federal Drug Association is severely lost.

References:

Am J Psychiatry. June 15 2009