ADHD Medications and Sudden Death Risks

The black box warning from the Food and Drug Administration (FDA) is a denotation of serious and/or life threatening adverse effects of a medication. It is called a black box or black label warning because of the black outline around the warning on the label. The FDA can require drug makers to place the label on certain medications if they find sufficient evidence of a serious side effect. ²

In February 2006, after analyzing different reports of sudden deaths in children taking stimulant medication for ADHD had been analyzed, the FDA decided to place the black box warning on these medications. However the decision was overturned the following month. ²

One study analyzed the sudden deaths in children on the medications and compared them to the same number of children who died in car accidents. The result of that study found that the risk of death in kids being treated with ADHD medications was 7.4 times higher than their peers who died in the car accidents. ¹

This study also cautioned that parents not stop the medication immediately. The reasoning being that if your child were already on the medication safely for some time they were not really at risk of sudden death. The sudden deaths were attributed to unknown underlying heart conditions in the children. ¹

Doctors concluded from the study that family history of heart problems should be taken into account more seriously. If a child had a family history then testing, such as EKGs, could be performed to assess the heart's health. If no heart conditions were found, then the child should be safe to take the medications without risk of sudden death.¹

The cases of sudden death, while frightening and unfortunate, were very rare. The study comparing accidental to sudden, unknown causes of death found that out of the 564 kids who were on ADHD medication, only 10 of the deaths were unexplainable. ¹

Still, as a parent, if it were my child I wouldn't care how rare it was. Now, however, the information is available and parents should feel safe making an informed decision about having their child either taking the medications or not. If your doctor isn't willing to run the heart tests to check for unknown conditions, you should switch physicians to find one who takes your concerns more seriously.

Sources:

¹ADHD Drugs Linked to Sudden Death in Kids, http://www.drugs.com/news/adhd-linked-sudden-death-kids-18304.html

² Black Box Warnings, http://en.wikipedia.org/wiki/Black_box_warning