FDA Responds to Citizen Petitions Requesting Black Box Warnings on Dopamine Agonists for Restless Legs Syndrome

In a 39-page letter dated October 21, 2019, the US Food and Drug Administration (FDA) responded to citizen petitions filed by nonprofit health research and advocacy group Public Citizen and health economics and outcomes research company BioMedEcon LLC in December 2016 and June 2017, respectively, regarding their concerns about the dopamine agonist drug class and psychiatric adverse effects. Three dopamine agonists—Mirapex, Neupro, and Requip—are approved for the treatment of restless legs syndrome (RLS).
The FDA denied the requests for black box warnings, REMS (Risk Evaluation and Mitigation Strategy), Medication Guides, and DHCP (“Dear Health Care Provider”) letters.

The FDA partially granted a request in the BioMedEcon petition; it agreed that new safety information should be included in the labeling of dopamine agonists. The FDA is notifying Mirapex, Neupro, and Requip that they need to change language in the Warnings and Precautions, Patient Counseling Information and Patient Information sections of labeling “to clarify that patients may experience impulse control disorders (ICDs) and hallucinations/psychotic-like behavior while taking these products for the treatment of RLS.”