Adderall: FDA Issues Stronger Warnings for ADHD Stimulants

Adderall: FDA Issues Stronger Warnings for ADHD Stimulants

The FDA now requires the manufacturers of amphentamine-containing ADHD drugs (Adderall) to include a black box warning, which is found in the package insert, informing patients about the possibility of sudden death and serious cardiovascular problems associated with these drugs.

A black box warning is the strongest type of warning that the FDA can request on a drug's professional product label. However, the statement "misuse of amphetamines may cause sudden death and serious cardiovascular adverse events" is extremely misleading because it doesn't tell patients that the drugs can also cause sudden death in those using the medication properly.

Sudden death has been reported in association with the use of stimulant ADHD drugs in the recommended doses in children, adolescents, and adults with structural heart abnormalities or other serious heart problems, such as a heart murmur or abnormal heart rhythm - not just in those who misuse stimulants.

The FDA should immediately take steps to change this statement to say that sudden death and serious complications can occur in a wide variety of people who are not misusing the drugs.

In addition to the new black box warning, the un-boxed warnings section of the labels for amphetamine-containing drugs now require that children, adolescents or adults who are being considered for treatment with stimulant drugs for ADHD have a careful medical history assessment, including assessment for a family history of sudden death or heart rhythm disturbance. Patients should undergo a physical examination to assess for the presence of heart disease. Further evaluation could be necessary if the findings of an electrocardiogram and echocardiogram do suggest heart disease. (subscription required)