Reports of Sudden Unexplained Death (SUD) Involving Children Being Studied by FDA After Adderall Withdrawn in Canada

An article entitled "Myocardial infarction in an adolescent taking Adderall", by Pritesh J. Gandhi, et.al., was published recently in the American Journal of Health-system Pharmacy.

This medical journal article reports on the case of a boy who arrived at his local hospital’s emergency room with symptoms of a heart attack, or myocardial infarction (MI), after taking Adderall for his attention-deficit/hyperactivity disorder (ADHD). To the author’s knowledge, this the first published case report of an acute MI caused by oral use of Adderall without intent to overdose. The article acknowledges that there have been previous reports of patients who had heart attacks associated with amphetamines which involved intentional overdose or illicit drug use.

In more depth, a 15-year-old white male presented with some chest pain and a shortness of breath even when at rest.  At this point, we go to the article’s text:

His medical history was significant for ADHD, for which various medication regimens had been prescribed since age six years. Four months before this arrival to the ED, treatment with Adderall tablets (Shire Richwood, Inc.) was started at a total amphetamine dosage of 5 mg (1.25 mg each of amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate) p.o. twice daily. The total daily amphetamine dosage was increased by 5 mg weekly based on the patient’s clinical response. The patient stated that, for the past four weeks, he was supposed to be taking two Adderall tablets, each containing 20 mg total of amphetamine and dextroamphetamine salts, in the morning. He voluntarily stopped taking the Adderall for about three weeks because he wanted to know how he would function without the medication. However, a teacher noted aggressive behavior and asked him to resume the medication. He restarted the medication (two 20-mg tablets daily) approximately one week before this admission without notifying his physician.

As some may be aware, Adderall XR (an extended-release amphetamine–dextroamphetamine product) was withdrawn from the market in Canada after Health Canada considered reports of sudden unexplained death (SUD) in children taking Adderall or Adderall XR in the U.S.  The FDA is currently evaluating that same data for SUD cases involving children receiving Adderall, as well as other post-marketing reports of serious side effects in patients treated with Adderall, to determine whether Adderall should stay on the market, here.

Although instances of sudden unexplained death had been reported in children with underlying cardiac abnormalities during Adderall treatment, recently SUD has also been reported in a small number of children without structural cardiac abnormalities who received Adderall.  Of 12 cases of pediatric sudden death reported to the FDA, only five of those cases occurred in children with underlying structural cardiac abnormalities. Several of the remaining cases were complicated by other medical conditions and factors, such as family history of ventricular tachycardia.

Read more about the withdrawal of Adderall from the market in Canada and the FDA’s Adderall Alert.

(Posted by: Tom Lamb)