Dopamine Agonists: US FDA Orders Safety Labeling Changes But Not Boxed Warnings

23 Oct 2019

Agency denies citizen petition requests for boxed warning on risk of impulse control behaviors and other psychiatric disorders with the class of drugs used to treat Parkinson’s disease and restless legs syndrome, but agrees with one petitioner that some safety-related changes are warranted.

Warning sign with exclamation mark on striped caution tape — US FDA is broadening some dopamine agonist warning language to patients with restless legs syndrome. • Source: Shutterstock

The US Food and Drug Administration is requiring labeling changes, but not boxed warnings, for some dopamine agonists to better reflect the risks of impulse control disorders (ICD) and other psychiatric disorders.

The agency’s action comes in a joint response to two citizen petitions that sought boxed warnings about impulse control behaviors...