FDA Rejects "Black Box" Warning for Stimulant Meds

An FDA advisory group recommends making existing stimulant labels easier to understand.

An FDA advisory panel has recommended against requiring pharmaceutical companies to add a "black box" warning label to commonly prescribed AD/HD medications. Instead, the pediatric panel recommended rewriting the current label to make risks and side effects easier to understand.

The recommendation of the panel, whose members are experts in the field of children's health, came one month after a previous FDA panel, composed of drug-safety experts, called for the addition of a black box warning.

The drug-safety panel said they recommended the strong warning label because they believed doctors may be overprescribing AD/HD meds. It acted after Canadian authorities briefly banned sales of Adderall XR last year, because of concerns that the drug contributed to heart failure deaths in children. Critics said no link between the drugs and heart problems had been established.

The FDA will now decide what action to take. The agency is not required to follow the recommendations of its advisory panels.